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Pilot Study to Evaluate the Contribution of Gene Variants to Idiopathic Urolithiasis
Jacksonville, FL
Recent investigations from this group have identified that genetic variants of genes associated with monogenic forms of nephrolithiasis are expressed in idiopathic calcium oxalate kidney stone patients and could influence stone forming risk. Utilizing patient samples from the Mayo Clinic Florida Kidney Stone Registry, we will demonstrate that expression of these heterozygous mutations in idiopathic nephrolithiasis act as genetic modifiers of disease presentation increasing risk of kidney stone formation. Complimented by the analysis of environmental and lifestyle risk factors, these studies will define environmental and genetic susceptibility factors involved in kidney stone formation and reoccurrence.
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Ixabepilone and Temsirolimus in Treating Patients with Solid Tumors that are Metastatic or Cannot ce Removed by Surgery
Jacksonville, FL; Rochester, MN
This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in treating patients with solid tumors that have spread from the primary site to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with temsirolimus may kill more ...
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A Study to Evaluate the Impact of a Pharmacist-led Oral Anticancer Medication (OAM) Program on Patient Outcomes
La Crosse, WI
The purpose of this study is to evaluate the impact of integrating a pharmacist-led OAM education program within the interdisciplinary oncology team at the Stephen and Barbara Slaggie Family Cancer Center and Blood Disorders Center within Mayo Clinic Health System – La Crosse.
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Financial Toxicity Among Patients In Phase I Clinical Trials
Rochester, MN
As medical care in the United States becomes increasingly expensive, cost stewardship is a necessary component of delivering high value care. Cancer patients require additional protection from unmanageable costs, as the average out of pocket (OOP) cost during the first month of diagnosis is as high as $2900. Financial toxicity (FT) describes the adverse impact that the cost of treatment imposes upon our patients. Over the last five years, FT has become a well-recognized adverse impact of a cancer diagnosis. FT not only decreases the patient's quality of life, but also patients who file bankruptcy during cancer treatment ...
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Gut Microbiome In Solid Tumor Management
Rochester, MN
The purpose of this research is to study the impact of the bacteria in the intestine (gut) on the efficacy and side effects of the anticancer therapies.
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A Study To Evaluate Accelerated Resolution Therapy In Cancer And Palliative Care
Jacksonville, FL
The following research questions will guide this study: 1) Is ART feasible and acceptable for use with distressed patients and/or family caregivers in oncology and palliative care clinical settings? 2) What is the mean dose of ART provided to distressed patients and/or family caregivers? 3) What are the patient and family stressors that result in a recommendation for ART? 4) Does ART reduce symptoms of psychological trauma, anxiety and depression, when used with distressed patients and family caregivers in oncology and palliative care clinical settings? 5) Does ART improve resilience when used with distressed ...
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Collection and Storage of Tissue and Blood Samples From Patients With Cancer
Rochester, MN
This research trial collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.
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Effectiveness of Nurse-based Care Coordination on Readmissions among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
Rochester, MN
The purpose of this study is to evaluate nurse-based care coordination compared to usual care on 30-day risk-adjusted readmission rates among high risk patients.
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Long Term Follow-Up Of Subjects Exposed To GSK3377794
Jacksonville, FL; Rochester, MN
The purpose of this long-term, followup study is to evaluate subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
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Study Of MRTX1133 In Patients With Advanced Solid Tumors Harboring A KRAS G12D Mutation
Scottsdale/Phoenix, AZ
The purpose of this study is to characterize the safety and tolerability of MRTX1133 as monotherapy or combined with cetuximab in patients with advanced KRAS G12D-mutant solid tumors, and to evaluate the pharmacokinetics (PK) of MRTX1133.
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Virtual Mindfulness And Weight Management Program In Patients With Cancer Histories
La Crosse, WI
The purpose of this study is to improve well-being and promote weight loss using a virtual mindfulness and activity promotion program among rural patients with a history of cancer.
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Using Virtual Community Health Workers To Connect Patients To Cancer Research Studies
Jacksonville, FL
The purpose of this study is to quantitatively examine, via a post-test only survey, a tailored intervention utilizing virtual human technology (VHT) to improve communication with rural and ethnic/racial minority patients and their willingness to participate in clinical research as an ultimate means to increase the diversity of NCI-sponsored clinical trials (CCTs).
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Collaborative Targeted Case Management In Improving Functional Status In Patients With Stage III-IV Cancer
Rochester, MN
This randomized clinical trial studies collaborative targeted case management in improving functional status in patients with stage III-IV cancer. Collaborative targeted case management may improve functional status and preserve performance in patients with advanced cancer
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Dual BET And CBP/p300 Inhibitor In Patients With Targeted Advanced Solid Tumors And Hematological Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies
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Efficacy And Safety Study Of Tisotumab Vedotin For Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if tisotumab vedotin is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur.
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A Study To Investigate LYL845 In Adults With Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
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Safety And Tolerability Of TNG908 In Patients With MTAP-deleted Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first in human study in patients with deleted Methylthioadenosine phosphorylase (MTAP) advanced or metastatic solid tumors is to detertamine dose escalation in part one and dose expansion in specific MTAP-deleted tumor types.
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A Study Of SPX-303, A Bispecific Antibody Targeting LILRB2 And PD-L1 In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.
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Long-Term Follow-up Protocol For Participants Treated With Gene-Modified T Cells
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
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A Study To Evaluate MRTX849 In Patients With Advanced Solid Tumors With KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation.
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Grief Among Older Adult Family Caregivers
Jacksonville, FL
The purpose of this study is to evaluate the trajectory of loss and grief over 12 months, the risk factors associated with high levels of pre-loss grief, and the preliminary effectiveness of ART for treatment of high levels of pre-loss grief among family caregivers (FCG) of persons nearing the end of life.
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Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma
Jacksonville, FL; Scottsdale/Phoenix, AZ
to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.
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Study Of RP-6306 With Gemcitabine In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
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Study To Test The Safety And Tolerability Of PF-07257876 In Participants With Selected Advanced Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this FIH study is to assess the safety and tolerability, effectiveness, pharnacokinetcs (PK), and pharmacodynamics (PD) of increasing dose levels of PF-07257876; to identify the MTD and potential RP2D of PF-07257876; and to select the RP2D for further studies in development. This study will enroll patients with advanced cancers with no curative therapy (NSCLC, SCCHN, and OvCa) whose tumors have either failed prior PD-1 or PD-L1 therapies (NSCLC or SCCHN); or platinum-based chemotherapy (OvCa). In addition, patients’ tumors must have demonstrated PD-L1 expression > 1%.
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Long-term Safety And Effectiveness Study For Participants With Advanced Tumors Who Are Currently On Treatment Or In Follow-up In A Pembrolizumab Trial
Rochester, MN
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who rollover into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase.
Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study.
Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this ...
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A Study To Assess The Effectiveness And Safety Of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin In Patients Not Previously Treated For Metastatic Pancreatic Cancer, Compared To Nab-paclitaxel+Gemcitabine Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to look at the effectiveness and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
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A Study Of LSTA1 When Added To Standard Of Care Versus Standard Of Care Alone In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test a new drug plus standard treatment compared with standard treatment alone in patients with advanced head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and cholangiocarcinoma. The main questions it aims to answer are: -is the new drug plus standard treatment safe and tolerable -is the new drug plus standard treatment more effective than standard treatment.
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A Registry Study For The Long-Term Outcomes Of Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this long term registry study is to collect and analyze information from patients being treated with various forms of radiation therapy to improve the treatment of future patients.
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A Study Investigating DNA-damage Response Agents In Molecularly Altered Advanced Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the effectiveness, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations.
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A Study To Evaluate The Safety And Therapeutic Activity Of GI-102 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to evaluate the safety and tolerability of GI-102 to define the MTD and/or RP2D.
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PRE-I-SPY Phase I/Ib Oncology Platform Program
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
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PATHFINDER 2: A Multi-Cancer Early Detection Study
Rochester, MN
The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test.
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Tumor Infiltrating Lymphocytes Biobank
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this repository is to provide clinical samples to support basic science and translational research efforts to improve TIL therapy. The process of isolating TILs from tumor tissue involves processing of fresh tissue from surgical specimens, and this protocol would establish a novel collection for tissue that would not otherwise be available through current tissue banks.
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A Study Of Imlunestrant Versus Standard Endocrine Therapy In Participants With Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
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Testing The Addition Of MEDI4736 (Durvalumab) To Chemotherapy Before Surgery For Patients With High-Grade Upper Urinary Tract Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery ...
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Hematology Electronic Consultations (e-Consults) the Mayo Clinic Experience
Jacksonville, FL
The purpose of this study is to evaluate hematology e-consults to determine their specific use, time to completion, advantages and disadvantages, perceptions from primary care physicians and specialists and economic impact.
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Preoperative Radioactive Seed Localization of Nonpalpable Soft Tissue Masses
Jacksonville, FL
The purpose of this study is to see if there is a subjective improvement in operative time, incision length, volume of tissue removed and margin status when using seed localization versus no localization and to assess patient and surgeon attitudes toward seed localization.
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A Study of the Gene Make-up of Heart Tumors
Rochester, MN
The purpose of this study is to help identify the biology of heart tumors and understand how and why they form.
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A Study to Determine Number of Rounds of Plasma Exchange Needed to Decrease Measles Virus Antibodies for Measles Virus Cancer Therapy
Rochester, MN
The purpose of this study is to determine how many rounds of plasma exchange are required for maximal decrease in measles antibodies and how long it may last, for the successful use of measles virus cancer therapy.
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Study Of IBI3020 Treatment In Participants With Late-Stage Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
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Patient And Caregiver Experience Of Bone Marrow Transplant
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to collect both survey and qualitative data from patients and caregivers in order to obtain descriptive data necessary to formulate and develop future empirical studies and intervention efforts that address bone marrow transplant (BMT) patient/caregiver well-being.
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A Study To Evaluate KIN-3248 In Participants With Advanced Tumors Harboring FGFR2 And//or FGFR3 Gene Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary effectiveness of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.
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Measuring Well Being In Cancer Patients Utilizing Apple Watch And IPhone
Rochester, MN
The purpose of this study is to understand how the Apple watch and iPhone can collect data on quality of life in cancer patients.
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Learning From Patients How They Were Educated On Chemotherapy Side Effects
Rochester, MN
To learn in patients’ own words how they were educated on chemotherapy side effects, what aspects of that education were most helpful, and what aspects could be done better (and why).
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A Study Of The Safety And Effectiveness Of Methylene Blue MMX® Modified Release Tablets Administered To Subjects Undergoing Screening Or Surveillance Colonoscopy
Rochester, MN
The purpose of this study is the evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
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MUC1 TCell receptor repertoire
Rochester, MN
Can T cell receptor repertoires serve as a biomarker of T cell response to a MUC1 vaccine?
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MRI Techniques For Early-stage Detection Of Cancer
Rochester, MN
The purpose of this study is to develop 7T MRI techniques for early-stage detection of cancer, using both hydrogen (1H) and deuterium (2H) imaging.
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A Clinical Study To Test If An Investigational Treatment Called BNT326 Is Safe And Potentially Beneficial When Used Alone Or In Combination With Other Investigational Treatments Such As BNT327, For People With Advanced Malignant Tumors
Scottsdale/Phoenix, AZ
This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.
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A Study To Evaluate A Resilient Living Program For Patients With Advancer Cancer And Their Caregivers
Rochester, MN
The primary purpose of this study is to determine feasibility as measured by consent of at least 25% of eligible patients and their caregivers (defined as those who met with the study coordinator), adherence (75% of the enrolled participants will complete at least 3 of the 4 Resilient Living sessions), and acceptability (measured by ) of the delivery of the Resilient Living intervention to patients with advanced cancer and their caregivers.
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A Study To Evaluate The Safety And Efficacy Of A2B530, A Logic-gated CAR T, In Subjects With Solid Tumors That Express CEA And Have Lost HLA-A*02 Expression
Jacksonville, FL; Rochester, MN
The purpose of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A*02 expression.
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Quality-Adjusted Survival in Allogeneic Hematopoietic Cell Transplant Patients
Rochester, MN
The utilization of hematopoietic cell transplantation (HCT) has increased dramatically over the past decade. Although it is potentially lifesaving for a variety of primarily malignant diseases, allogeneic HCT carries a significant burden of short- and long-term morbidity with potential threats to quality of life (QOL), impairments in cognitive and psychological functioning, as well as impact on spiritual and philosophical view of life. The main aim of this pilot study is to evaluate treatment-related toxicity and clinical indicators of QOL in HCT patients, and to integrate these into a multidimensional quality-adjusted survival (QAS) model using the Quality-Adjusted Time Without Symptoms or ...
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Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy
Rochester, MN
This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.
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A Study of Caring Hand Massage for Cancer Patients Undergoing Chemotherapy in an Outpatient Setting
Rochester, MN
The purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.
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A Study of Sinonasal Carcinomas at Mayo Clinic Rochester
Rochester, MN
The purpose of this study is to to create an electronic database of these cases and study the demographics, clinical and pathological characteristics and treatment details of sinonasal carcinomas.
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Trimethoprim-sulfamethoxazole Graded Administration in Oncology, Hematopoietic Stem Cell Transplant, and Solid Organ Transplant Patients with a History of Sulfonamide Allergy
Rochester, MN
The aim of this study is to study the efficacy and safety of our short and long one-day protocols for TMP-SMX graded administration in hematologic malignancy, hematopoietic stem cell transplant, and solid organ transplant patients.
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Effects of Cognitive Function, Post-op Fatigue and Quality of Life Comparing General vs Regional Anesthesia for Non-eloquent Brain Tumors Resection
Jacksonville, FL
The aim of the study is to create a registry to prospectively collect pre-operative, during surgery and post-operative data, questionaries will assess (at baseline before the surgery, 3-4 weeks, and at 3-6 months) cognitive function, assessed with a Mini-mental State Examination (MMSE), PROMIS Fatigue 7a form, quality of life (QoL), assessed using the SF-12 questionnaire, quality of sleep assessed using PROMIS Sleep disturbance 7a form (1 week after surgery).
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A Study to Explore Cancer Patient Experiences and Their Decisions About Sharing Genetic Cancer Screening Information with Family Members
Rochester, MN
The purpose of this study is to characterize the beliefs and attitudes of cancer patients who received a positive result from a genetic cancer screen as part of the Mayo Clinic Intercept study (IRB#18-000326, PI: Samadder). This data will be collected using semi-structured, one-on-one interviews.
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Supportive Care Needs and Resource Assessment in Cancer Patients
Scottsdale/Phoenix, AZ
This study is investigating the supportive care needs, and levels of social support and distress, in adult patients who are receiving or have recently completed treatment for cancer. Research has shown that when cancer patients are supported with resources to help them cope with the cancer and treatment experience, that they are better able to tolerate and cope with their treatment and its impact.
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A Study Of Cell, Serum, And Bone Marrow Bank For Patients Receiving Chimeric Antigen Receptor T Cell Therapy For The Treatment Of Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to store blood, serum and bone marrow so that they can be used for laboratory studies that may contribute to finding the exact function of the CART cells or T-cell engager therapy such as bispecific and trispecific antibodies and the factors that may determine disease progression and treatment response.
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KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models
Rochester, MN
This study will assess the ability of the Pathos platform to predict which patients will respond to certain colorectal cancer drug treatments. To demonstrate that for patients with advanced colorectal cancer, prediction scores based on in vitro tumor organoid drug response are positively associated with the rate of first line response.
To demonstrate that for patients with advanced colorectal cancer, prediction scores based on in vitro tumor organoid drug response are positively associated with progression free survival.
To demonstrate that for patients with advanced colorectal cancer who meet the endpoint of first line response, prediction scores ...
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Virtual Reality Intervention To Improve Psychological Symptom Burden For Cancer Patients Undergoing Treatment
Jacksonville, FL
This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to ...
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Mayo Clinic Radiotherapy Patient Outcomes Registry And Biobanking Study
Albert Lea, MN; Scottsdale/Phoenix, AZ; Rochester, MN
To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with radiation therapy.
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Couple Communication In Cancer: A Multi-Method Examination - Renewal 1
Scottsdale/Phoenix, AZ
The purpose of this study is to identify communication profiles of couples based on EMA and observational data. This aim will be addressed in two phases. In phase I, we will construct measures of empirically- and theoretically derived communication behaviors and patterns using our observational and EMA data. In Phase II, we will use these measures in latent profile analyses to identify distinct profiles of couples.
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The In4M Study: Integrating 4 Measures To Assess Physical Function In Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the measurement characteristics of these different sources of physical function data in a cancer population undergoing cytotoxic chemotherapy.
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A Study To Evaluate The Role Of Gut Microbiome In Cancer Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to correlate gut microbiome with specific cancer diagnoses and the clinical response (effectiveness), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.
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Group Meaning-Centered Psychotherapy For The Improvement Of Wellbeing In Caregivers Of Patients With Advanced Cancer
Jacksonville, FL; Rochester, MN
This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual ...
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A First-in-Human Study Of BG-C137, An Anti-FGFR2b Antibody Drug Conjugate, In Participants With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.
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A Study To Evaluate Enfortumab Vedotin To Treat Metastatic Squamous Cell Carcinoma Of The Penis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to estimate the best response of enfortumab vedotin treatment for patients with metastatic squamous cell carcinoma of the penis (PSCC).
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Etigilimab And Nivolumab In Subjects With Locally Advanced Or Metastatic Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors.
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My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, And Tecentriq Treatment Targeted Against Certain Molecular Alterations In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
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PRT3789 Monotherapy And In Combo W/Docetaxel In Participants W/Advanced Or Metastatic Solid Tumors W/SMARCA4 Mutation
Jacksonville, FL; Rochester, MN
This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.
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Study Of AB598 Monotherapy And Combination Therapy In Participants With Advanced Cancers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.
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A First-in-human Study Of 3HP-2827 In Patients With Unresectable Or Metastatic Solid Tumors With FGFR2 Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
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A Study To Evaluate Visually Inspired Patient Education Material On Willingness To Pursue Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to measure how patient anxiety changes using a validated patient reported outcome measure, to measure radiotherapy completion rates in the American Indian/Alaska Native (AI/AN) community, and to measure patient perception of information received using a validated patient reported outcome measure.
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A Study To Evaluate Zanubrutinib To Treat Patients With B-cell Malignancies
Rochester, MN
The purpose of this study is to evaluate the long-term safety and effectiveness of zanubrutinib in participants with B-cell malignancies who were previously enrolled in an eligible BeiGene study.
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NOLA (NeuWave Observational Liver Ablation) Registry
Jacksonville, FL
The purpose of this study is to create a registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.
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Grief Among Older Adult Family Caregivers
Jacksonville, FL
The purpose of this study is to evaluate the trajectory of loss and grief over 12 months, the risk factors associated with high levels of pre-loss grief, and the preliminary effectiveness of ART for treatment of high levels of pre-loss grief among family caregivers (FCG) of persons nearing the end of life.
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Patient Experience in Treatment for Low-grade Upper Tract Urothelial Carcinoma
Jacksonville, FL; Scottsdale/Phoenix, AZ
to identify, describe, and substantiate important and relevant concepts related to (1) the signs, symptoms, and impacts of Low grade upper tract urothelial carcinoma (LG UTUC); (2) treatment burden and patients’ current treatment experiences for LG UTUC; and (3) perceptions of UGN-101, a novel topical chemotherapy for LG UTUC treatment, from the perspective of US-based adults with LG UTUC.
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Study Of RP-6306 With Gemcitabine In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
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Study To Test The Safety And Tolerability Of PF-07257876 In Participants With Selected Advanced Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this FIH study is to assess the safety and tolerability, effectiveness, pharnacokinetcs (PK), and pharmacodynamics (PD) of increasing dose levels of PF-07257876; to identify the MTD and potential RP2D of PF-07257876; and to select the RP2D for further studies in development. This study will enroll patients with advanced cancers with no curative therapy (NSCLC, SCCHN, and OvCa) whose tumors have either failed prior PD-1 or PD-L1 therapies (NSCLC or SCCHN); or platinum-based chemotherapy (OvCa). In addition, patients’ tumors must have demonstrated PD-L1 expression > 1%.
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A Study To Assess The Effectiveness And Safety Of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin In Patients Not Previously Treated For Metastatic Pancreatic Cancer, Compared To Nab-paclitaxel+Gemcitabine Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to look at the effectiveness and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
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A Study Of LSTA1 When Added To Standard Of Care Versus Standard Of Care Alone In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to test a new drug plus standard treatment compared with standard treatment alone in patients with advanced head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and cholangiocarcinoma. The main questions it aims to answer are: -is the new drug plus standard treatment safe and tolerable -is the new drug plus standard treatment more effective than standard treatment.
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Long-term Safety And Effectiveness Study For Participants With Advanced Tumors Who Are Currently On Treatment Or In Follow-up In A Pembrolizumab Trial
Rochester, MN
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who rollover into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase.
Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study.
Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this ...
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A Study Investigating DNA-damage Response Agents In Molecularly Altered Advanced Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the effectiveness, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations.
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A Study To Evaluate The Safety And Therapeutic Activity Of GI-102 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to evaluate the safety and tolerability of GI-102 to define the MTD and/or RP2D.
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PRE-I-SPY Phase I/Ib Oncology Platform Program
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
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PATHFINDER 2: A Multi-Cancer Early Detection Study
Rochester, MN
The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test.
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Tumor Infiltrating Lymphocytes Biobank
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this repository is to provide clinical samples to support basic science and translational research efforts to improve TIL therapy. The process of isolating TILs from tumor tissue involves processing of fresh tissue from surgical specimens, and this protocol would establish a novel collection for tissue that would not otherwise be available through current tissue banks.
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A Study Of Imlunestrant Versus Standard Endocrine Therapy In Participants With Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
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A Registry Study For The Long-Term Outcomes Of Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this long term registry study is to collect and analyze information from patients being treated with various forms of radiation therapy to improve the treatment of future patients.
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Testing The Addition Of MEDI4736 (Durvalumab) To Chemotherapy Before Surgery For Patients With High-Grade Upper Urinary Tract Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery ...
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Return of Results of Pharmacogenomic Testing for Genes Involved in Metabolism of 5FU and Capecitibine
Rochester, MN
A group of Mayo Clinic Biobank participants were genotyped for genetic variants as part of a separate study and a subset were found to be carriers of one or more important variants that increased risk of severe (grade 3, 4 or 5) toxicity.
These variants were reviewed by experts at Mayo Clinic and judged to: 1) have important health implications (toxicity) for participants if they were ever exposed to pharmaceutical agents containing 5-fluoruracil, and 2) to be clinically actionable (change options for treatment).
The purpose of this study is to return results to participants enrolled in the Mayo Clinic ...
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MUC1 Gene Expression
Rochester, MN
Can the genetic makeup of an individual who does not yet have cancer provide an indication of the risk of future cancer?
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Prospective Use of Real-time MRI
Rochester, MN
This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.
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Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy
Rochester, MN
You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)
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Palliative Care and Oncology Site Visits
Rochester, MN
The purpose of this study impact of specialist palliative care delivery on endof-life varies between palliative care programs, and that differences in how programs are implemented modify their ability to affect specific metrics.
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A Study Of A New Molecular Approach To Blood DNA Screening For Cancer
Rochester, MN
The primary aim of this study is to evaluate the distribution of marker levels determined by this multi-marker, multi-compartment blood DNA test approach across persons without known cancer or precancer.
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Using Induced-Pluripotent Stem Cells To Model Cancer Therapy-Related Adverse Events
Jacksonville, FL
The purpose of this study is to use patient blood cells to perform individualized in vitro modeling of cancer therapy-related toxicities.
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A Study To Evaluate Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine And Prednisone (Par-CHOP) Immunochemotherapy For Patients With Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.
The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.
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A Study To Analyze The Association Between Financial And Health Insurance Literacy And Financial Distress In Patients Being Treated For Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the level of financial and health insurance literacy and financial distress in cancer patients coming to the infusion center by analyzing the correlation amongst these outcomes, as well assessing their association with baseline sociodemographic and disease/ treatment factors.
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Tumor Infiltrating Lymphocytes Biobank
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this repository is to provide clinical samples to support basic science and translational research efforts to improve TIL therapy. The process of isolating TILs from tumor tissue involves processing of fresh tissue from surgical specimens, and this protocol would establish a novel collection for tissue that would not otherwise be available through current tissue banks.
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A Study Of Imlunestrant Versus Standard Endocrine Therapy In Participants With Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
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A Study To Evaluate The Safety And Therapeutic Activity Of GI-102 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to evaluate the safety and tolerability of GI-102 to define the MTD and/or RP2D.
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PRE-I-SPY Phase I/Ib Oncology Platform Program
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.
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PATHFINDER 2: A Multi-Cancer Early Detection Study
Rochester, MN
The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test.
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A Registry Study For The Long-Term Outcomes Of Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this long term registry study is to collect and analyze information from patients being treated with various forms of radiation therapy to improve the treatment of future patients.
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Testing The Addition Of MEDI4736 (Durvalumab) To Chemotherapy Before Surgery For Patients With High-Grade Upper Urinary Tract Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery ...
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A Study to Assess Feasibility and Benefit of a Patient-reported Outcomes Quality of Life Tool for Hematology and Medical Oncology
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the feasibility and benefit of a patient-reported outcomes quality of life tool for hematology and medical oncology.
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A Study of Adherence Scores and Patient Satisfaction Scores to Oral Chemotherapy for Patients followed by a Pharmacist in an Outpatient Cancer Center
Scottsdale/Phoenix, AZ
The purpose of this study is to measure adherence scores to oral chemotherapy for patients educated and followed by a clinic-based pharmacist in an outpatient cancer center versus patients not followed by a pharmacist using patient reported adherence rates.
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Bemarituzumab Plus Chemotherapy And Nivolumab Versus Chemotherapy And Nivolumab Alone
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab to treat previously-untreated advanced gastric and gastroesophageal junction cancer.
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Cancer Distress
Rochester, MN
The purpose of this study is to explore patient feedback regarding how physician behaviors influence their distress level.
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Mapping Patient-Centered Decision-Making In
Metastatic Cancer Care Delivery In Florida
Jacksonville, FL
The purpose of this study is to explore and describe metastatic breast cancer (mBC) and metastatic urothelial cancer (mUC) patient perspectives on and experiences with treatment decision-making, including how patients evaluate various treatment options, associated benefits, risks and drawbacks as well as how perceptions and preferences change over time.
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Do Patients Diagnosed With Cancer Suffer From "scan-itis"?
Rochester, MN
The purpose of this study is to determine what patients experience when they return for scans or other testing during their oncology follow-up visits after their initial cancer diagnosis.
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A Study to Analyze The Impact of Pharmacist Consultation in Patients Beginning Intravenous Cancer Treatment
La Crosse, WI
The purpose of this study is to assess the impact of pharmacist consultation in patients receiving first dose, first cycle intravenous cancer treatment on patient understanding of the cancer treatment, adverse drug events, and adherence. Additionally, this study will report the frequency of healthcare utilization for side effect management.
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Pafolacianine For Localization Of Pediatric Extracranial Solid Tumors
Rochester, MN
The purpose of this study is to determine the utility of NIR fluorescent imaging using the molecular imaging agent CYTALUX for identifying lesions in children and adolescent patients with primary or metastatic solid tumors.
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A Study Investigating Integrated Genomics And Patient-derived Cancer Models
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The aim of this project is to characterize a landscape of DNA alterations and proteomic changes in both biopsies and resected tumors of patients which have been diagnosed with aggressive/metastatic disease to identify molecular targets for which therapeutic drugs may exist.
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Nurse-Led Acupressure Intervention For Patients Receiving Chemotherapy
Rochester, MN
The purpose of this study is to evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy.
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DCSZ11 As A Monotherapy In Patients With Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effects of DCSZ11, an anti-CD93 monoclonal antibody, as a monotherapy in patients with advanced or metastatic solid tumors.
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Predicting Responsiveness In Oncology Patients Based On Host Response Evaluation During Anti Cancer Treatments
Jacksonville, FL
The objectives of this study are to create a proteomic profile (Host Response) using plasma from patients before and after anti-cancer therapy, and to associate the changes in the levels of plasma proteins with response to treatment (ORR) as defined by RECIST 1.1 /other validated clinical scale to assess response.
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Study Of RP-3500 With Niraparib Or Olaparib In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of Niraparib or Olaparib in combination with RP-3500, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 in combination with Niraparib or Olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.
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A Study To Evaluate AB308 In Combination With AB122 In Participants With Advanced Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
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A Study Of SGN-CEACAM5C In Adults With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The puprose of the study is to test the safety of SGN-CEACAM5C in participants with Advanced solid tumors.
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A Study To Determine The Feasibility And Success Of Using A Web-based Distributed Quality Of Life (QOL) Survey To Collect Information After Abdominal Surgery
Jacksonville, FL
The overall objective of this study is to obtain patient reported outcomes regarding quality of life (QOL) via Mayo Clinic’s existing and well-established web-based portal that is easily available for download as a mobile app.
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Study Of ORIC-114 In Patients With Advanced Solid Tumors Harboring An EGFR Or HER2 Alteration
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor ORIC-114 when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.
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First In Human Study Of TORL-4-500 In Participants With Advanced Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer
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Vilastobart (XTX101) Monotherapy And Vilastobart And Atezolizumab Combination Therapy In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and atezolizumab combination therapy in patients with advanced solid tumors.
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A Study Of Physical Activity In Cancer Survivors
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN
The purpose of this study is to determine if to increasing physical activity (PA) will increase physical functioning, as measured by cardiovascular endurance, muscular strength, and balance in underserved adult cancer survivors of ages 18 or older residing at a rural address. Also, to deternube if increasing PA will increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors ages 18 or older residing at a rural address.
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Rose Geranium In Sesame Oil Nasal Spray For The Improvement Of Nasal Vestibulitis Symptoms In Cancer Patients Receiving Chemotherapy
Albert Lea, MN; Mankato, MN; Rochester, MN
This trial will be an evaluation of rose geranium in sesame oil nasal spray versus nasal saline. Rose geranium in sesame oil nasal spray is a compounded preparation, containing 0.2 mL (4 drops) of pharmaceutical grade rose geranium oil to 119.8 mL of pharmaceutical grade sesame oil and then put into 30mL bottles. This is the same compound that was used in the aforementioned study of patients with hereditary hemorrhagic telangiectasia (2). Isotonic nasal saline will contain 0.9% sodium chloride with benzalkonium chloride, as a preservative, in a 30 mL bottle.
Treatment duration
The therapy will ...
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Multi-Cancer Detection Observational Cohort Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Novel, high-performance genomic technologies now allow detection of signals from cancers in the blood, giving rise to a new paradigm of multi-cancer detection (MCD) tests. Blood is inherently well suited for detection of cancer biomarkers as it contains circulating tumor cells and tumor cell-free DNA (cfDNA) that have been “shed” from an occult asymptomatic developing cancer. MCD tests analyze these genomic features of the circulating DNA, distinguish it from background signals and determine a site of tumor origin to guide subsequent testing to establish a firm cancer diagnosis (hopefully pre-symptomatic early stage and highly curable). An effective MCD test should ...
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MUC1 Gene Expression
Rochester, MN
Can the genetic makeup of an individual who does not yet have cancer provide an indication of the risk of future cancer?
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Prospective Use of Real-time MRI
Rochester, MN
This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.
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Return of Results of Pharmacogenomic Testing for Genes Involved in Metabolism of 5FU and Capecitibine
Rochester, MN
A group of Mayo Clinic Biobank participants were genotyped for genetic variants as part of a separate study and a subset were found to be carriers of one or more important variants that increased risk of severe (grade 3, 4 or 5) toxicity.
These variants were reviewed by experts at Mayo Clinic and judged to: 1) have important health implications (toxicity) for participants if they were ever exposed to pharmaceutical agents containing 5-fluoruracil, and 2) to be clinically actionable (change options for treatment).
The purpose of this study is to return results to participants enrolled in the Mayo Clinic ...
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Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy
Rochester, MN
You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)
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Palliative Care and Oncology Site Visits
Rochester, MN
The purpose of this study impact of specialist palliative care delivery on endof-life varies between palliative care programs, and that differences in how programs are implemented modify their ability to affect specific metrics.
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A Study Of A New Molecular Approach To Blood DNA Screening For Cancer
Rochester, MN
The primary aim of this study is to evaluate the distribution of marker levels determined by this multi-marker, multi-compartment blood DNA test approach across persons without known cancer or precancer.
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Jacksonville, FL; Rochester, MN
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
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Effectiveness Of Mindfulness-Based Intervention On Patient Reported Outcomes Of Black Adult Cancer Survivors: A Community Faith-Based Mindfulness Ministry
Jacksonville, FL
The purpose of this study is to explore the transformative potential of spiritually aligned mindfulness practices tailored for Black adult cancer survivors. Recognizing the unique cultural and spiritual needs of this group, the research seeks to develop and evaluate a faith-based Mindfulness Based Intervention (MBI) model designed to enhance resilience and improve Quality of Life (QoL) during cancer survivorship. This goal will be achieved through two objectives: (i)develop a culturally modified MBSR curriculum that is adapted to align with congruent faith-based religious practices; (ii) test the impact of the developed culturally modified MBI intervention on improvement of wellbeing and QoL.
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Investigating Memory And Physical Activity After Cancer Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to examine associations between physical activity and cognition in survivors of adolescent or young adult (AYA) cancers, and enhance understanding of physical activity behaviors, preferences, barriers, facilitators, and outcome expectancies in AYA survivors.
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Phase 1a/1b Study Of Aplitabart (IGM-8444) Alone Or In Combination In Participants With Relapsed, Refractory, Or Newly Diagnosed Cancers
Scottsdale/Phoenix, AZ
The purpose of this first-in-human study is to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of Aplitabart (IGM-8444) +FOLFIRI (± bevacizumab).
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Virtual Dignity Therapy For Palliative Care Patients With Advanced Cancer
Rochester, MN
The purpose of this study is to determine if it is feasible to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer and whether the intervention is beneficial in terms of improvement in distress, patient dignity, and quality of life.
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A Study To Evaluate Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine And Prednisone (Par-CHOP) Immunochemotherapy For Patients With Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.
The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.
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A Study To Analyze The Association Between Financial And Health Insurance Literacy And Financial Distress In Patients Being Treated For Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the level of financial and health insurance literacy and financial distress in cancer patients coming to the infusion center by analyzing the correlation amongst these outcomes, as well assessing their association with baseline sociodemographic and disease/ treatment factors.
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A Study Of The Gut Microbiome In Chemotherapy Treatment
Rochester, MN
The purpose of this study is to investigate the impact of microbiome on the effectiveness and toxicity of anti-cancer therapy and to develop microbiome- based markers to personalize cancer treatment.
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Using Induced-Pluripotent Stem Cells To Model Cancer Therapy-Related Adverse Events
Jacksonville, FL
The purpose of this study is to use patient blood cells to perform individualized in vitro modeling of cancer therapy-related toxicities.
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Ulixertinib In People With Histiocytic Neoplasms
Rochester, MN
The purpose of this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
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A Study Of MK-1026 In Patients With Selected Hematologic Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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Use Of Navigator Echoes For 4D-MRI
Rochester, MN
The general aim of this proposal is to evaluate new non-significant risk (NSR) MRI technology in a clinical setting, specifically the use of preclinical (non-FDA-approved) sequences (including but not limited to bSSFP, SSFSE) which have been modified from their standard counterparts to include interleaved 1D body navigator pulses.
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Study To Compare The Safety And Effectiveness Of Treatment Combinations In Patients With Recurrent Ovarian Cancer
Rochester, MN
The primary purpose of this study is to evaluate the effectiveness of the niraparib combinations defined in each cohort-specific supplement, as assessed by confirmed objective response rate (ORR), in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
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Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout
Jacksonville, FL; Rochester, MN
This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.
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A Registry To Collect Patient And Family DNA And Information For Anyone Who Has Had Multiplex Testing And Gene Mutation Results
Rochester, MN
The purpose of this study is to collect patient and family DNA and disease data to learn more about how changes in certain genes may be linked to cancer. Some people with cancer may have aquired their disease because they inherited an abnormal (mutated) gene. The researchers of this study want to better understand the risks that are linked to genetic changes in these less well-studied genes. By understanding these risks, it is believed that doctors will be able to give better advice to families with mutations in these genes.
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A Study To Evaluate Zanubrutinib To Treat Patients With B-cell Malignancies
Rochester, MN
The purpose of this study is to evaluate the long-term safety and effectiveness of zanubrutinib in participants with B-cell malignancies who were previously enrolled in an eligible BeiGene study.
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NOLA (NeuWave Observational Liver Ablation) Registry
Jacksonville, FL
The purpose of this study is to create a registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.
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Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout
Jacksonville, FL; Rochester, MN
This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.
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A Study To Detect Cancers Through Elective Plasma-based CancerSEEK Testing
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to obtain clinically characterized, whole blood specimens from participants with new or suspected diagnosis of (cancer subjects) and from participants who do not have a diagnosis of cancer (healthy subjects) to develop and refine assays for cancer in the blood
The primary objective of this study is to obtain clinically characterized, whole blood specimens from cancer and healthy subjects to develop and refine assays for cancer in the blood.
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Targeted Therapy Directed By Genetic Testing In Treating Patients With Locally Advanced Or Advanced Solid Tumors, The ComboMATCH Registration Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This ComboMATCH patient registration trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. P
atients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) ...
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A Registry To Collect Patient And Family DNA And Information For Anyone Who Has Had Multiplex Testing And Gene Mutation Results
Rochester, MN
The purpose of this study is to collect patient and family DNA and disease data to learn more about how changes in certain genes may be linked to cancer. Some people with cancer may have aquired their disease because they inherited an abnormal (mutated) gene. The researchers of this study want to better understand the risks that are linked to genetic changes in these less well-studied genes. By understanding these risks, it is believed that doctors will be able to give better advice to families with mutations in these genes.
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Phase 1/2 Study Of MRTX1719 In Solid Tumors With MTAP Deletion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.
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Study Of Ociperlimab In Combination With Tislelizumab In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objectives of this study are to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion.
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A Phase 1 Study Of XL309 (ISM3091) Alone And In Combination In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.
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ADG126 In Combination With Pembrolizumab In Patients With Advanced/Metastatic Solid Tumors
Jacksonville, FL; Rochester, MN
This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.
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Ketoconazole In Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
Rochester, MN
This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
We would like to see if use of topical ketoconazole will improve rashes in patients with EGFR inhibitor-induced rash.
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A Study To Evaluate Artificial Intelligence-driven Assistance For Treatment Planning In Radiation Oncology
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the innovations under development for an AI-augmented service platform software are desirable for customers, viable for stakeholders, and feasible to build and deliver, a multi-disciplinary design team will conduct human-centered design research. The results of this research will help the team design, develop, build, and improve current and future products and services.
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INHERIT Study To Evaluate Proactive Genetic Testing In Cancer Patients
Jacksonville, FL
The goal of this study is to evaluate the integration of cancer genetic testing into a community cancer clinical practice aimed toward patients of various ethnic populations in north Florida including, but not limited to, African Americans, Hispanic/Latino, Native American/Alaskan and Asian, by self-report.
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A Phase 1/2a Study Of IMM-1-104 In Participants With Previously Treated, RAS-Mutant, Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IMM-1-104 when administered as monotherapy in participants with RAS-mutated advanced or metastatic solid tumors.
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Solid Tumor Monoclonal B-cell Lymphocytosis Screening
Rochester, MN
The purpose of this study is to determine whether monoclonal B-cell lymphocytosis (MBL) has an impact on clinical outcomes among patients with a diagnosis of a solid tumor.
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Methadone Versus Intrathecal Hydromorphone For Analgesia Patients Undergoing Surgery For Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Rochester, MN
The purpose of this study is to determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone. Our overall purpose is to identify the most effective and least invasive manner in which to achieve adequate postoperative analgesia in patients undergoing major gynecologic oncological surgery.
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A Study Of Enfortumab Vedotin Alone Or With Other Therapies For Treatment Of Urothelial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally-advanced and metastatic urothelial cancer, which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at ...
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MUC1 Gene Expression
Rochester, MN
Can the genetic makeup of an individual who does not yet have cancer provide an indication of the risk of future cancer?
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Prospective Use of Real-time MRI
Rochester, MN
This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.
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Return of Results of Pharmacogenomic Testing for Genes Involved in Metabolism of 5FU and Capecitibine
Rochester, MN
A group of Mayo Clinic Biobank participants were genotyped for genetic variants as part of a separate study and a subset were found to be carriers of one or more important variants that increased risk of severe (grade 3, 4 or 5) toxicity.
These variants were reviewed by experts at Mayo Clinic and judged to: 1) have important health implications (toxicity) for participants if they were ever exposed to pharmaceutical agents containing 5-fluoruracil, and 2) to be clinically actionable (change options for treatment).
The purpose of this study is to return results to participants enrolled in the Mayo Clinic ...
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Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy
Rochester, MN
You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)
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A Study Of A New Molecular Approach To Blood DNA Screening For Cancer
Rochester, MN
The primary aim of this study is to evaluate the distribution of marker levels determined by this multi-marker, multi-compartment blood DNA test approach across persons without known cancer or precancer.
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Palliative Care and Oncology Site Visits
Rochester, MN
The purpose of this study impact of specialist palliative care delivery on endof-life varies between palliative care programs, and that differences in how programs are implemented modify their ability to affect specific metrics.
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A Study To Evaluate Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine And Prednisone (Par-CHOP) Immunochemotherapy For Patients With Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.
The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.
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A Study To Analyze The Association Between Financial And Health Insurance Literacy And Financial Distress In Patients Being Treated For Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the level of financial and health insurance literacy and financial distress in cancer patients coming to the infusion center by analyzing the correlation amongst these outcomes, as well assessing their association with baseline sociodemographic and disease/ treatment factors.
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A Study Of The Gut Microbiome In Chemotherapy Treatment
Rochester, MN
The purpose of this study is to investigate the impact of microbiome on the effectiveness and toxicity of anti-cancer therapy and to develop microbiome- based markers to personalize cancer treatment.
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Using Induced-Pluripotent Stem Cells To Model Cancer Therapy-Related Adverse Events
Jacksonville, FL
The purpose of this study is to use patient blood cells to perform individualized in vitro modeling of cancer therapy-related toxicities.
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Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
Jacksonville, FL; Rochester, MN
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
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Effectiveness Of Mindfulness-Based Intervention On Patient Reported Outcomes Of Black Adult Cancer Survivors: A Community Faith-Based Mindfulness Ministry
Jacksonville, FL
The purpose of this study is to explore the transformative potential of spiritually aligned mindfulness practices tailored for Black adult cancer survivors. Recognizing the unique cultural and spiritual needs of this group, the research seeks to develop and evaluate a faith-based Mindfulness Based Intervention (MBI) model designed to enhance resilience and improve Quality of Life (QoL) during cancer survivorship. This goal will be achieved through two objectives: (i)develop a culturally modified MBSR curriculum that is adapted to align with congruent faith-based religious practices; (ii) test the impact of the developed culturally modified MBI intervention on improvement of wellbeing and QoL.
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Investigating Memory And Physical Activity After Cancer Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to examine associations between physical activity and cognition in survivors of adolescent or young adult (AYA) cancers, and enhance understanding of physical activity behaviors, preferences, barriers, facilitators, and outcome expectancies in AYA survivors.
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Phase 1a/1b Study Of Aplitabart (IGM-8444) Alone Or In Combination In Participants With Relapsed, Refractory, Or Newly Diagnosed Cancers
Scottsdale/Phoenix, AZ
The purpose of this first-in-human study is to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of Aplitabart (IGM-8444) +FOLFIRI (± bevacizumab).
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Ulixertinib In People With Histiocytic Neoplasms
Rochester, MN
The purpose of this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.
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Virtual Dignity Therapy For Palliative Care Patients With Advanced Cancer
Rochester, MN
The purpose of this study is to determine if it is feasible to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer and whether the intervention is beneficial in terms of improvement in distress, patient dignity, and quality of life.
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A Study Of MK-1026 In Patients With Selected Hematologic Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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Use Of Navigator Echoes For 4D-MRI
Rochester, MN
The general aim of this proposal is to evaluate new non-significant risk (NSR) MRI technology in a clinical setting, specifically the use of preclinical (non-FDA-approved) sequences (including but not limited to bSSFP, SSFSE) which have been modified from their standard counterparts to include interleaved 1D body navigator pulses.
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Study To Compare The Safety And Effectiveness Of Treatment Combinations In Patients With Recurrent Ovarian Cancer
Rochester, MN
The primary purpose of this study is to evaluate the effectiveness of the niraparib combinations defined in each cohort-specific supplement, as assessed by confirmed objective response rate (ORR), in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer.
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A Study of Pharmacogenomics (PGx) Results and Clinical Data of Patients in the Palliative Medicine Clinic to Assess Current and Future Therapeutic Relevance
Scottsdale/Phoenix, AZ
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for a group of patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of medications
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Dynamics Of Clinical Trial Discussions In Oncology To Identify Patient Barriers And Help Develop A Patient-centered Intervention To Increase Participation In Clinical Trials
Rochester, MN
The purposes of this study are to richly describe the content and dynamics of clinical trial discussions in oncology and compare the knowledge, beliefs, and attitudes of oncology patients, caregivers, and clinicians related to clinical trials, and to develop a multifaceted, patient-centered intervention for increasing patient understanding of and participation in clinical trials in oncology.
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Patient And Caregiver Perspective About Financial Distress Of Cancer Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to understand the need and gap in interventions addressing financial burden from a patient perspective, and develop a psychoeducational intervention directed towards decreasing financial distress in patients undergoing cancer treatment based on the knowledge gained.
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Hereditary Cancer Registry
Jacksonville, FL
The purpose of this study is to develop and maintain a clinical registry database of all patients seen at Mayo Clinic Florida who have completed genetic testing through Mayo Clinic Florida or are seen due to a previously identified hereditary cancer risk.
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Radiation Treatment Planning Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to integrate a novel head and neck segmentation algorithm into the current clinical standard operating procedure for radiation treatment planning within the Mayo Clinic Department of Radiation Oncology Practice.
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Assessing Benefits And Harms Of Cannabis/Cannabinoid Use Among Cancer Patients Treated In Community Oncology Clinics
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.
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Study Of Zanzalintinib In Combination With Immuno-Oncology Agents In Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.
In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
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Evaluating Patient Reported Outcomes In Radiation Therapy, The PRO-RT Study
Rochester, MN
The purpose of this study is to address the gaps in data completeness regarding treatment toxicities, patient reported outcomes, and biometric information. Hugo device enabled patient specific data aggregation, will increase the completeness and accuracy of the Outcomes Registry and improve patient engagement with the care teams, post radiation, by acquiring linked outside EHR information facilitating improved collection of patient reported outcome surveys, and biometric data via a wearable device.
With a rise in health care costs, there is an urgent need to evaluate patient outcomes and the value of care levering real patient, big data from the ...
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3D Surface Scanning
Scottsdale/Phoenix, AZ
The purpose of this study is to examine the potential for using a 3D scan of a patient’s treatment surface as a surrogate for a conventional CT simulation in electron radiation therapy.
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A Study To Evaluate Wound Infiltration With Liposomal Bupivacaine In Laparotomy For Gynecological Malignancy
Rochester, MN
The purpose of this study is to determine whether or not there is a benefit to adding opioid injection around the spinal cord ( intrathecal) to incisional long-acting local anesthetic (liposomal bupivacaine) injection for pain management after abdominal surgery for gynecological cancer.
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Establishment Of The Lynx Dx Cancer Research Biobank For Advancing Clinical Studies On Urinary Biomarkers
Jacksonville, FL
The purpose of this study is to establish a repository of well-documented and properly preserved biospecimens for use in research regarding urinary biomarker tests for the workup of PCa.
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INCB161734 For Advanced Or Metastatic Solid Tumors With KRAS G12D Mutation
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
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A Study To Evaluate The Safety And Effectiveness Of Lisocatagene Maraleucel In Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.
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Safety And Efficacy Of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells In Subjects With Relapsed Or Refractory BAFFR-expressing B-cell Hematologic Malignancies
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of escalating doses of MC10029 following lymphodepleting (LD) therapy in subjects with relapsed or refractory BAFFR-expressing B-cell hematologic malignancies to determine the recommended dose for phase 1b (dose expansion).
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A Study Of The Use Of Cold Caps To Prevent Hair Loss In Chemotherapy Patients
Rochester, MN
The purpose of this study is to learn, in patients’ own words, what cancer patients who are using a cold cap to prevent hair loss are experiencing.
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Genomic And Proteomic Analyses Of Aggressive Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use genomic and proteomic analyses to identify possible diagnostic markers and potential drugs for diagnosing and treating aggressive tumor types or neoplastic processes. Genomic analyses mean looking at the genome, or all the DNA in a cell (DNA is a material in your body that is a genetic map or code that provides instructions that make up your genes). Proteomic analyses mean looking at the proteome, or all the proteins expressed, or made, by DNA at a specific moment in time
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Sym021 In Combination With Either Sym022 Or Sym023 Or Sym023 And Irinotecan In Patients With Advanced Biliary Tract Carcinomas
Rochester, MN
The purpose of this study is to evaluate the preliminary effectiveness of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym023+Irinotecan) in Biliary Tract Cancer by assessing ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. This study will also evaluate the safety and tolerability profile of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym023+Irinotecan).
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Phase 1 Study Of Oral TP-1454
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors as monotherapy and in patients who are eligible for standard of care treatment with ipilimumab and nivolumab as combination therapy, and to establish the dose of TP-1454 recommended to be used alone and in combination with ipilimumab and nivolumab in future studies for selected advanced solid tumors.
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Intercept Somatic
Rochester, MN
The goal of this study is to assess the diagnostic yield of concomitant germline and somatic tumor profile testing in a population of cancer patients unselected for family cancer history. In this study, we will retrospectively perform TMP on all cancer patients enrolled into the IRB 18-00326 who underwent germline genetic testing and have tumor tissue available within the Mayo Clinic Tissue Archives. TMP will be performed using a 435 gene platform, along with assessment of tumor mutational burden and microsatellite instability status, among other analyses. Paraffin-embedded tissues will be obtained from the Mayo Tissue Registry and will ...
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A Study To Investigate ALE.P02 As Monotherapy In Adult Patients With Selected CLDN1+ Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.
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Clinical And Epidemiological Studies In Pediatric Malignancies
Rochester, MN
The purpose of this study is to establish a bank of tissue, stool, and blood from pediatric participants newly diagnosed with a malignancy for future studies.
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Phase 2 Trial Of Adagrasib Monotherapy And In Combination With Pembrolizumab And A Phase 3 Trial Of Adagrasib In Combination In Patients With A KRAS G12C Mutation KRYSTAL-7
Jacksonville, FL; Rochester, MN
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.
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Focal MR-Guided Focused Ultrasound Treatment Of Localized Intermediate Risk Prostate Lesions
Rochester, MN
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above..
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Olanzapine For The Treatment Of Chronic Nausea And/or Vomiting In Advanced Cancer Patients
Mankato, MN; Rochester, MN
The purpose of this study is to conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated nausea/vomiting.
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Tumor Molecular Analysis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to develop preclinical models that include cell lines and patient derived xenografts (PDX) that include molecular characterization and testing novel therapies in these preclinical models. Molecular characterization may include short tandem DNA repeat; STR) and oncogenic/tumor suppressor gene mutation analyses to assure that the derived models have not been cross contaminated during the development process with other ongoing lines. Tissue microarray and immunohistochemical (IHC) analysis will also be performed on cell lines, PDX and patient tissues to identify potential molecular targets for therapy.
For patients who consented, patient clinical therapy response data may be correlated with ...
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A Randomized Evaluation Of Machine Learning Assisted Radiation Treatment Planning Versus Standard Radiation Treatment Planning
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.
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Group Curriculum For Improving Survivorship Outcomes In Adolescent And Young Adult Cancer Survivors
Scottsdale/Phoenix, AZ
The purpose of this study is to develop the curriculum and assess its feasibility and impact on equipping young adults to better manage these aspects of survivorship: follow up medical care, work/school life, relationships and coping with the emotional impact of cancer survivorship.
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Study Of EO-3021 In Adult Patients With Solid Tumors Likely To Express CLDN18.2
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the single-agent EO-3021 recommended phase 2 dose (RP2D) and schedule for further exploration in patients with advanced solid tumors that are likely to express CLDN18.2.
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A Study To Measure The Impact Of Continuous Positive Airway Pressure For Reducing Breathing Motion
Rochester, MN
The purpose of this study is to measure the extent that breathing motion is reduced in healthy volunteers after continuous positive airway pressure (CPAP) used. If CPAP administration will significantly reduce breathing motion, this may help cancer patients who are undergoing proton radiotherapy, so they may not have to hold their breath during the procedure.
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A Study to See if Clinical Cardiac MRI Scanning Can Cause DNA Damage
Rochester, MN
The long-term goal of this research program is to clarify the potential mutation causing and cancer causing risk posed by clinical magnetic resonance imaging (MRI).
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A Study of Rose Geranium in Sesame Oil Nasal Spray for Treating Established Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to
- Explore the efficacy of rose geranium in sesame oil nasal spray in treating nasal vestibulitis related to cancer-directed therapy.
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A Study Of AP160-Complex In Advanced Solid Tumors
Rochester, MN
This is a single arm phase I study designed to determine the MTD and toxicity profile of the AP160 complex (nab-paclitaxel/STI-3031 complex) in the treatment of advanced or metastatic non-neurological solid tumors using the standard cohort 3+3 design (5 dose levels) followed by an expansion cohort of an additional 6 patients. Patients are dosed Days 1, 8, and 15 of every 28 day cycle. Response will be assessed per RECIST 1.1; patients will have CT/MRI ~Q8WK (2 cycles) on study. Patients will have tumor biopsies at screening and EOT to evaluate PDL1 expression and TME. Blood samples will be taken ...
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A Study Of Healthy Donor Volunteers To Provide Blood Components Via Leukapheresis For In Vitro Dendritic Cell Investigations
Scottsdale/Phoenix, AZ
The purpose of this study is to collect blood cells as a healthy donor for use in research studies, which will focus especially on using the immune system’s cells to fight infection and cancer. Blood cells collected as part of participation in this Research Donor Program will be used strictly for laboratory experiments and will not be used for transfusion back into human beings.
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A Study to Examine the Genomic Testing Practices by Hematology/Oncology Physicians at Mayo Clinic in Florida
Jacksonville, FL
The purpose of this study is to examine the genomic testing practices by Hematology/Oncology physicians at Mayo Clinic in Florida in an effort to 1) catalogue the number and type of panel-based tests used as well as 2) determine how often the test findings informed the clinical decision making for the physician and their patient.
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A Study To Validate DNA Methylation Markers For Universal And Site-specific Guided Cancer Detection
Rochester, MN
The purpose of this study is to validate candidate universal and site-specific methylated DNA markers (MDMs) in DNA extracted from formalin-fixed paraffin embedded primary tumor and control specimens.
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A Study To Learn How Research Sites Successfully Recruited To A Geriatric Oncology Trial That Relied On Electronic Patient-reported Outcomes (EPRO)
Rochester, MN
The purpose of this study is to analyze how research sites successfully recruit geriatric oncology patients using electronic-reported patient outcomes.
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First In Human Study Of TORL-1-23 In Participants With Advanced Cancer
Rochester, MN
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
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A Study Of The Pan-KRAS Inhibitor LY4066434 In Participants With KRAS Mutant Solid Tumors
Scottsdale/Phoenix, AZ
The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.
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A Study Of ELI-002 7P In Subjects With KRAS/NRAS Mutated Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
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Aliya™ Pulsed Electric Fields (PEF) Delivered Prior To Standard Of Care Treatment For Advanced Cancer
Jacksonville, FL; Rochester, MN
The purpose of this early feasibility study (EFS) is to evaluate the safety of delivering Aliya pulsed electric fields ablation in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
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A Study To Assess The Implementation Of An Investigational Multi-Cancer Early Detection Test Into Clinical Practice
Rochester, MN
The purpose of this study is to evaluate an investigational, multi-cancer early detect test developed by Grail, Inc. with the results returned to a study investigator.
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Personalized Neoantigen Peptide-Based Vaccine In Combination With Pembrolizumab For The Treatment Of Advanced Solid Tumors, The PNeoVCA Study
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of personalized neoantigen peptide administered in combination with pembrolizumab to patients with advanced solid tumors. Patients' tumors will be sequenced during a pre-registration component or will have had successful sequencing pre-study. A personalized neoantigen peptide vaccine containing up to 20 unique peptides will be manufactured for each qualifying patient based on the results.
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JAB-21822 Activity In Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives of this study are to evaluate the overall safety and tolerability of JAB-21822 monotherapy, and to determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) of JAB-21822 and in combination with cetuximab administered by prescription (QD) in participants with relapsed or refractory solid tumors with KRAS G12C mutation.
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Individualized Preoperative Rehabilitation Pilot
Rochester, MN
A pilot to test feasibility of improving patient/caretaker quality of life and resilience.
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A Phase 1/2 Study Of MRTX0902 In Solid Tumors With Mutations In The KRAS MAPK Pathway
Rochester, MN
The purpose of this study is to characterize the safety and tolerability of MRTX0902 as monotherapy or in combination with selected cancer therapeutic agents in patients having advanced solid tumor malignancies harboring mutations in the KRAS-MAPK pathway.
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Prospective Use Of Philips ISuite For Interventional Procedures
Rochester, MN
This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.
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A Study To Evaluate ARV-806 In Adults With Advanced Cancer That Has The KRAS G12D Mutation
Scottsdale/Phoenix, AZ
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806.
Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is ...
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In Vitro 3D Cell Culture Models Validation For Tumor Drug Sensitivity After Tissue Removal
Rochester, MN
The purpose of this study is to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.
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International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Rochester, MN
This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease ...
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A Study Of Cognitive Behavioral Cancer Stress Management (CBCSM) And Its Effects On Cancer Distress
Rochester, MN
The purpose of this study is to test the effectiveness of cancer stress management (CBCSM) as a clinical service at Mayo Clinic.
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Advance Care Planning: Promoting Effective And Aligned Communication In The Elderly
Rochester, MN
In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery. - It is expected that about 30,000 patients and their oncologists will take part in this research study, 29,550 of these patients, the vast majority, will be included only for medical record review. At Mayo, 90 clinicians will participate along with 10,000 patients (9850 medical record review). Note that the minimum age of 65 pertains to the patient participants and not the clinicians.
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Study Of RAS(ON) Inhibitors In Patients With Gastrointestinal Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The first three subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel
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Response to PD-1 Blockade in Patients with Mismatch Repair Deficient Colorectal Cancer
Rochester, MN
This study will assess the efficacy and outcomes of PD-1 blockade in patients with mismatch repair deficient colorectal cancer.
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ADVANCE
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this research study is to understand the views and experiences of African American women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk.
This is a qualitative interview study. Study participation involves talking on the phone or videoconference (e.g., Zoom) for about 1 hour with a researcher.
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A Study To Explore Tumor Biology In Metastatic Esophageal And Gastric Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to explore various biomarkers in the post-treatment tissue of patients who have responded to cancer therapy and compare it to the biopsy performed prior to cancer treatment.
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Testing The Addition Of An Anti-Cancer Drug, Gemcitabine, To Usual Treatment (BCG Alone) In People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with ...
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Gleolan For Visualization Of Newly Diagnosed Or Recurrent Ovarian Cancer (OVA-302)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
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A Study To Assess Endometrial Cancer Recurrence In Patients After 36 Months
Rochester, MN
The purpose of this study is to assess the 36-month incidence of pelvic/non-vaginal recurrence among patients with surgical stage I intermediate-risk endometrial cancer.
Eligible patients presenting with apparent uterine confined grade 1, 2, or 3 endometrioid endometrial cancer will undergo standard-of-care primary surgical treatment with a cervical injection of indocyanine green (ICG) dye for SLN mapping, a total hysterectomy, removal of the adnexae and staging with sentinel node mapping and pelvic washings.
The final assessment for inclusion in the follow-up part of the study will be determined from the results of the final hysterectomy and staging pathology report to ensure bilaterally negative pelvic sentinel ...
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A Study Of DKN-01 In Combination With Tislelizumab ± Chemotherapy In Patients With Gastric Or Gastroesophageal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of DKN-01 in combination with tislelizumab ± CAPOX (capecitabine + oxaliplatin) in patients with inoperable, locally advanced or metastatic G/GEJ adenocarcinoma.
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Atezolizumab In Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back and has not responded to treatment with Bacillus Calmette-Guerin (BCG). Monoclonal antibodies, such as atezolizumab, may block specific proteins found on white blood cells which may strengthen the immune system and control tumor growth.
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A Study To Test The Addition Of The Immunotherapy Drug Pembrolizumab To The Usual Chemotherapy Treatment (Paclitaxel And Carboplatin) In Stage III-IV Or Recurrent Endometrial Cancer
Rochester, MN
The purpose of this study is to determine how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs ...
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Study Of DS-8201a In Subjects With Advanced Solid Malignant Tumors
Jacksonville, FL
This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.
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Leveraging Methylated DNA Markers (MDMs) In The Detection Of Endometrial Cancer And Cervical Cancer: A Phase II Clinical Study
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.
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VSV-hIFNbeta-NIS In Treating Patients With Stage IV Or Recurrent Endometrial Cancer
Rochester, MN
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells.
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Time Longitudinal Study Of The Microbiome In Colorectal Cancer Subjects
Rochester, MN
The primary purpose of this study is to characterize the microbes that are causal of colorectal cancer and those that are merely conditions of the tumor. This will be accomplished by comparing the microbiomes before and after resection.
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A Study To Test How Well Different Doses Of BI 3706674 Are Tolerated By People With Advanced Cancer In The Stomach And Oesophagus
Scottsdale/Phoenix, AZ
The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone, and to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing.
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A Study To Evaluate The Effectiveness And Safety Of Pembrolizumab Combined With Bacillus Calmette-Guerin In High-Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction or that is naïve to BCG treatment.
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Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
Rochester, MN; Jacksonville, FL
This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.
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Associations Between Chemotherapy-Induced Nausea In Patients With Genitourinary Cancer And Changes In Gut Microbiome
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is investigate if functions and composition of the gut microbiome are associated with the occurrence of chemotherapy-induced nausea (CIN). Also, to evaluate the feasibility of patient recruitment and retention, as well as specimen collection and to evaluate for changes in alpha and beta diversity as well as composition (i.e. relative abundance) of the gut microbiome from T1 to T2 in patients who do and do not report CIN at T2. In addition, to examine associations between microbial composition functional profiles at T1 and T2 in patients who report CIN at T2.
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Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood In Patients With Relapsed And Resistant Ovarian Cancer
Scottsdale/Phoenix, AZ
The purpose of this study determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing ovarian cancer.
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Trans-Pacific Multicenter Collaborative Study Of Minimally Invasive Proximal Versus Total Gastrectomy For Proximal Gastric And Gastroesophageal Junction Cancers
Rochester, MN
The purpose of this study is to compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
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Polyphenon E in Treating Patients with High-Risk of Colorectal Cancer
Rochester, MN
This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.
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A Phase II Clinical Trial Comparing The Efficacy Of RO7198457 Versus Watchful Waiting In Patients With CtDNA-positive, Resected Stage II (High Risk) And Stage III Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer.
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A Study To Evaluate The Combination Of Margetuximab, Retifanlimab, MGD013, And Chemotherapy Phase 2/3 Trial In HER2+ Gastric/GEJ Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the effectiveness of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and margetuximab combined with INCMGA00012 or MGD013 and chemotherapy compared to trastuzumab combined with chemotherapy (Cohort B).
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A Study Evaluating Pembrolizumab And Epacadostat In Treating Participants With Recurrent, Persistent, Or Progressive Ovarian Clear Cell Carcinoma
Rochester, MN
The purpose of this trial is to assess how well pembrolizumab and epacadostat work in treating participants with ovarian clear cell carcinoma that has come back, remains despite treatment, or is growing, spreading, or getting worse. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and epacadostat may work better in treating participants with ovarian clear cell carcinoma.
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Claudin18.2 CAR-T (CT041) In Patients With Gastric, Pancreatic Cancer, Or Other Specified Digestive Cancers
Rochester, MN
A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.
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A Study to Compare Docetaxel/Prednisone to Docetaxel/Prednisone Combined with OGX-011 in Men with Prostate Cancer
Rochester, MN
The purpose of this study is to confirm that adding custirsen to standard first-line docetaxel and prednisone treatment can slow tumor progression in men who have prostate cancer, and enhance survival outcomes compared to standard first-line docetaxel and prednisone treatment alone.
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A Study to Compare Intravesical Therapy and Surgery to Treat Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery ...
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A Study To Validate An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test For Colorectal Cancer Screening
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
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Testing Pump Chemotherapy In Addition To Standard Of Care Chemotherapy Versus Standard Of Care Chemotherapy Alone For Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
Rochester, MN
The purpose of this study is to compare hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable).
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MV-NIS Infected Mesenchymal Stem Cells In Treating Patients With Recurrent Ovarian Cancer
Rochester, MN
This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with recurrent ovarian cancer. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian cancer cells.
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Tucatinib And Trastuzumab For Patients With HER2-positive Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This is a phase II trial that will study how well tucatinib (ONT-380) and trastuzumab work in treating patients with colorectal cancer with a specific genetic marker (human epidermal growth factor receptor 2 - HER2) that has spread to other places in the body or has come back and cannot be removed by surgery. Tucatinib has been found to specifically target and inhibit HER2.
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A Safety And Efficacy Study Of Treatment Combinations With And Without Chemotherapy In Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).
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RP2/RP3 In Combination With Atezolizumab And Bevacizumab For The Treatment Of Patients With CRC
Scottsdale/Phoenix, AZ; Rochester, MN
The purpoose of this study is to evaluate therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.
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Safety And Activity Of PolyPEPI1018 Plus Atezolizumab In Colorectal Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
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Iodine I-131 With Or Without Selumetinib In Treating Patients With Recurrent Or Metastatic Thyroid Cancer
Rochester, MN
This randomized phase II trial studies how well iodine I-131works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Because of this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose ...
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S0820, Adenoma and Second Primary Prevention Trial
Rochester, MN
The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.
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Use of Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy and Risk of Malignancy in Genetic Mutation Carriers
Rochester, MN
The purpose of this study is to determine if an increase risk of malignancy occurs in these patients if they use hormonal replacement therapies after a risk reducing salpingo-oophorectomy
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A Study To Evaluate Hyperthermic Intraperitoneal Chemotherapy To Treat Patients With Pancreatic Cancer And Peritoneal Metastasis
Rochester, MN
The primary purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.
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Ultrasensitive Detection Of Target Micro-RNAs And Nucleic Acids In Small Volume Blood Samples Of Advanced Stage Prostate And Kidney Cancer Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the feasibility of successfully obtaining serial finger-prick blood samples from castrate resistant prostate cancer and metastatic renal cell cancer patients using a specific (HemaSpot-SE ™) collection kit.
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Novel Study Interventions And Combinations In Participants With Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with CRC.
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Nivolumab And Ipilimumab In Treating Patients With Esophageal And Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
Rochester, MN
The purpose of this study is to anayze the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy ...
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Testing The Addition Of Abemaciclib To Olaparib For Women With Recurrent Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to identify the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them ...
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A Study To Compare Letrozole With Or Without Paclitaxel And Carboplatin In Treating Patients With Stage II-IV Ovarian Or Primary Peritoneal Cancer
Albert Lea, MN; Rochester, MN
The purpose of this study is to evaluate how well letrozole, with or without paclitaxel and carboplatin, works in treating patients with stage II-IV low-grade serous carcinoma of the ovary or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is ...
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Ovarian and Uterine Cancer Patients' Cancer Diagnosis and Treatment-Related Characteristics from Medical Records
Rochester, MN
The purpose of this study is to extract ovarian and uterine cancer patients' phenotypes at diagnosis and cancer treatments (side-effects, symptoms and clinical test values) from medical records using medical informatics approaches.
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Evaluation Of Outcomes In Metastatic Gastric And Esophageal Carcinoma In Relation To Immunotherapy
Rochester, MN
The purpose of this study is:
To assess the efficacy of treatment with checkpoint inhibitors (Pembrolizumab or Nivolumab) in metastatic gastric and esophageal carcinoma through retrospective chart review.
To explore if response to checkpoint inhibitors is dependent on biomarkers on tumor tissue.
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A Comprehensive Translational Research Platform For Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overarching goal of this study is to develop a comprehensive translational research platform that utilizes blood, stool, and tissues from colorectal cancer patients to evaluate the impact of tumor/immune microenvironment and genetic alterations on clinical outcomes to anticancer therapy and vice versa. The specific aims are to establish co-cultures of patient-derived tumor cells with autologous or allogeneic immune cells to analyze how anticancer therapy modulate the composition and potential of immune cells, to establish patient-derived xenographs and organoids to improve dosing of chemotherapy, and to perform molecular analysis with biospecimens to identify novel therapeutic sequence, targets, and predictive or ...
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Hypofractionated Radiotherapy With Folfox For Esophageal/Gej Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate non-inferiority of pCR with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.
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NRG-GY012 “A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, And The Combinations Of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5356 (Capivasertib) In Women With Recurrent, Persistent Or Metastatic Endometrial Cancer. A Multi-Arm Trial For Women With Recurrent Or Persistent Endometrial Cancer”
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The purpose of this randomized phase II trial study is to determine how well olaparib, cediranib maleate, and Week 1 inhibitor AZD1775 work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib, cediranib maleate, and Wee1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study To Evaluate Ramucirumab Plus Trifluridine/Tipiracil To Treat Patients With Previously-treated Advanced Gastric Or Gastro-esophageal Junction Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/Gastroesophageal Junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with TAS-102 vs. paclitaxel and ramucirumab.
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Specimen Collection From Participants Due For Colorectal Cancer Screening, Surveillance, Or Treatment
Rochester, MN
The purpose of this study is to collect de-identified, clinically characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays and devices for early detection of colorectal neoplasia.
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Novel SEQUEnced Immunotherapy With Anti-angiogenesis And Chemotherapy In Advanced GastroesophageaL Adenocarcinoma (SEQUEL)
Rochester, MN
This is a randomized Phase 2 study of novel SEQUEnced immunotherapy (pembrolizumab) with anti-angiogenesis and chemotherapy in advanced gastric and gastroesophageaL junction (GEJ) adenocarcinoma (SEQUEL) designed to to evaluate the best overall response rate (BORR) of combined ramucirumab (RAM) plus paclitaxel (+/- pembrolizumab) following induction pembrolizumab (PEM) in patients with advanced gastric and GEJ adenocarcinoma.
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A Study Of SC-006 In Subjects With Advanced Cancer
Rochester, MN
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC), and consists of Part A (dose regimen finding), followed by Part B (dose expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A.
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Response to PD-1 Blockade in Patients with Mismatch Repair Deficient Colorectal Cancer
Rochester, MN
This study will assess the efficacy and outcomes of PD-1 blockade in patients with mismatch repair deficient colorectal cancer.
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ADVANCE
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this research study is to understand the views and experiences of African American women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk.
This is a qualitative interview study. Study participation involves talking on the phone or videoconference (e.g., Zoom) for about 1 hour with a researcher.
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A Study To Explore Tumor Biology In Metastatic Esophageal And Gastric Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to explore various biomarkers in the post-treatment tissue of patients who have responded to cancer therapy and compare it to the biopsy performed prior to cancer treatment.
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Testing The Addition Of An Anti-Cancer Drug, Gemcitabine, To Usual Treatment (BCG Alone) In People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with ...
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A Study To Assess Endometrial Cancer Recurrence In Patients After 36 Months
Rochester, MN
The purpose of this study is to assess the 36-month incidence of pelvic/non-vaginal recurrence among patients with surgical stage I intermediate-risk endometrial cancer.
Eligible patients presenting with apparent uterine confined grade 1, 2, or 3 endometrioid endometrial cancer will undergo standard-of-care primary surgical treatment with a cervical injection of indocyanine green (ICG) dye for SLN mapping, a total hysterectomy, removal of the adnexae and staging with sentinel node mapping and pelvic washings.
The final assessment for inclusion in the follow-up part of the study will be determined from the results of the final hysterectomy and staging pathology report to ensure bilaterally negative pelvic sentinel ...
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Gleolan For Visualization Of Newly Diagnosed Or Recurrent Ovarian Cancer (OVA-302)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
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Atezolizumab In Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back and has not responded to treatment with Bacillus Calmette-Guerin (BCG). Monoclonal antibodies, such as atezolizumab, may block specific proteins found on white blood cells which may strengthen the immune system and control tumor growth.
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A Study Of DKN-01 In Combination With Tislelizumab ± Chemotherapy In Patients With Gastric Or Gastroesophageal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to characterize the safety and tolerability of DKN-01 in combination with tislelizumab ± CAPOX (capecitabine + oxaliplatin) in patients with inoperable, locally advanced or metastatic G/GEJ adenocarcinoma.
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A Study To Evaluate Hormone Concentrations In Patients With Metastatic Cancer
Rochester, MN
The purpose of this study is to correlate the parathyroid hormone-related peptide (PTHrp) levels in the current and new assays in patients with known disease and calcium status.
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Detection Of Recurrent Colorectal Cancer By Assay Of Novel Methylated DNA Markers In Plasma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary aims for this study:
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To select an optimal panel of novel MDMs for detection of recurrent or metastatic CRC and to assess MDM panel accuracy (sensitivity & specificity) for this application.
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To evaluate the ability of the plasma MDM assay to predict CRC recurrence when tested serially following curative resection of CRC metastases.
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A Study of the Safety and Effectiveness of TH-302 Combined with Gemcitabine and Compared with Gemcitabine Alone for Previously Untreated Patients with Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if TH-302 combined with Gemcitabine versus Gemcitabine alone is as safe and effective in the treatment of patients who have first-line metastatic pancreatic adenocarcinoma.
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A Study of the Safety and Effectiveness of TH-302 Combined with Gemcitabine and Compared with Gemcitabine Alone for Previously Untreated Patients with Pancreatic Adenocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if TH-302 combined with Gemcitabine versus Gemcitabine alone is as safe and effective in the treatment of patients who have first-line metastatic pancreatic adenocarcinoma.
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A Study of Adding AMG 479 to First Line Chemotherapy in Patients with Optimally Debulked Epithelial Ovarian Cancer
Rochester, MN
The purpose of this study is to determine the value of adding AMG 479 (a fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin (first line chemotherapy) for the treatment of patients who have ovarian epithelial cancer that has been surgically removed to less than 1 cm thick.
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A Study to Evaluate Fallopian Tube Serous Tubal In Situ Carcinoma Lesions
Jacksonville, FL; Rochester, MN
The purpose of this study is to examine the biology of Serous Tubal In Situ Carcinoma (STIC) lesions by conducting a proteomic and genomic analysis of STIC lesions. Fallopian tube serous tubal in situ carcinoma (STIC) lesions are thought to be precursors of fallopian tube and ovarian cancer.
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A Study to Assess Tissue Mechanical Properties as a Prognostic Biomarker of Breast Cancer using MR Elastography
No Locations
The purpose of this study is to investigate the mechanical properties of breast tissue on MRE (including stiffness, elasticity, viscosity, and volumetric stain) to find any correlation between these variables with breast density and background parenchymal enhancement, both of which are considered independent risk factors for breast carcinoma. We can also assess any suspicious lymph nodes noted on diagnostic MRI and correlate with stiffness values of the lymph nodes on MRI.
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Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery
Rochester, MN
This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
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Experiences of Acupuncture among Breast Cancer Survivors
Rochester, MN
The purpose of this study is to determine the feasibility and perceived effectiveness of acupuncture for breast cancer-related symptoms.
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CCK As A Treatment For Pancreatic Acinar Cell Carcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to learn more about the function of CCK receptor in human ACC cells and test the effect of high concentration CCK on ACC cells.
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A Study To Compare Positron Emission Mammography With Contrast-Enhanced Breast MRI For Detecting Breast Cancer
Rochester, MN
The purpose of this study is to compare the detection sensitivity of positron emission mammography to contrast-enhanced breast MRI in women with a high suspicion of breast cancer.
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Assessing Breast Cancer Risk Among Hispanic Women In Maricopa County
Scottsdale/Phoenix, AZ; Rochester, MN
The objective of this study is to explore the perceptions of under- and uninsured, Hispanic women living in Maricopa County around mammography screening to understand if deploying a BRCA model in community settings is a culturally acceptable strategy for reducing disparities in mammography access and use.
In 2019, breast cancer (BC) was the leading cause of death among Hispanic women in Maricopa County, Arizona (AZ) – Mayo Clinic Arizona’s (MCA) primary catchment area where Hispanics comprise 30% of the population. Mammography screening has been associated with a nearly 25% reduction in mortality, but Hispanic women have a lower ...
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Detecting Significant Prostate Cancer Based on Molecular Alterations Associated With Cancer in Non-neoplastic Prostate Tissue
Rochester, MN
The goal of this study is to improve detection of prostate cancers that require treatment. Achieving the aims of this research will lead to better care and reduced anxiety for patients suspected of aggressive prostate cancer.
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A Study Of Alternative Site Goserelin Acetate Injection For OFS In Local And Locally Advanced Premenopausal Breast Cancer
Rochester, MN
The purpose of this study is to determine if monthly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer. To determine if quarterly upper gluteal region administration of goserelin maintains ovarian function suppression (OFS) after switching from monthly abdominal administration of goserelin in pre-menopausal hormone positive breast cancer.
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MC1733, Phase I Trial Of Intratumoral Administration Of A Measles Virus Derivative Expressing The Helicobacter Pylori Neutrophil-activating Protein (NAP) (MV-s-NAP) In Patients With Metastatic Breast Cancer
Rochester, MN
To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measeles virus genetically engineered to express NAP (MV-s-NAP) in patients with metastatic breast cancer; to determine the safety and toxicity of on-time and serial administration of MV-s-NAP in patients with metastic breast cancer.
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Collection of Tissue, Blood Samples, and Cystic Fluid in Patients with Benign, Premalignant and/or Malignant Pancreatic Disease
Jacksonville, FL
The goal of this study is to establish and maintain a biospecimen bank containing samples of neoplasms, cysts, normal tissue, blood and/or any other tissue or cystic fluid from patients undergoing a diagnostic or therapeutic procedure for pancreatic disease.
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Resectable, Borderline Resectable, And Locally Advanced Pancreatic Cancer Biorepository Of Peripheral Blood
Rochester, MN
This biorepository is meant to collect longitudinal peripheral blood research samples for the purposes of biomarker studies. Such studies are meant for the purposes of measuring minimal residual disease in the perioperative setting, assess dynamics of treatment response, and to determine predictive value of risk stratification.
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A Trial Of RAdium-223 And SABR Versus SABR For OligomEtastatic Prostate CaNcerS (RAVENS)
Rochester, MN
The primary purpose of this study is to assess progression-free survival of men who have oligometastatic prostate cancer after randomization to stereotactic ablative radiation therapy (SABR) versus SABR and Radium-223.
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Targeting Inflammation For Endometrial Cancer Prevention
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to develop a unique data and specimen model for a biobank that can be expanded across the Mayo Enterprise and implemented at extramural collaborative sites, including underserved populations. The targeted demographic will be African American and white women undergoing hysterectomy for benign conditions or endometrial cancer (EC).
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18F-DOPA PET In Sarcoma Patients
Jacksonville, FL
The purpose of this study is to identify early response biomarkers from biological or functional imaging to better align with clinical trial endpoints and minimize sarcoma patient toxicities.
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Assessment Of The Safety, Ultrasound Conspicuity, And Migration Of Twinkling Markers In Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Systemic Therapy And Surgery, UTMOST Trial
Rochester, MN
In patients with breast cancer which has metastasized to the lymph nodes under the arm, treatment involves marking one of the metastatic nodes at the time of needle sampling for later removal after months of systemic therapy before surgery. When patients respond well to systemic therapy, the marked node can be hard to find by ultrasound, the imaging modality of choice. Mayo has designed a marker that is conspicuous by ultrasound and has shown short-term safety and good performance in a Phase 0 Clinical Trial. This study investigates the hypothesis that the Mayo marker will be safe, detectable by ultrasound, and minimally ...
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A Study To Evaluate The Safety And Effectiveness Of Hypofractionation Proton Beam Therapy In Patients With Clinically Localized, Intermediate, Or High Risk Prostate Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of a moderate hypofractionation regimen of proton beam therapy with same time treatment of the prostate, seminal vesicles, and the regional pelvic nodes for patients who have clinically localized, high risk or unfavorable intermediate risk prostate cancer.
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Study Of Cabozantinib Combined With Atezolizumab Vs. Second Novel Hormonal Therapy In Subjects With Metastatic Castration-Resistant Prostate Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.
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Asynchronous Skin Cancer Risk Using 3D Total-Body Photograph
Rochester, MN
The purpose of this study it to compare two approaches for executive health skin cancer screening to assess the level of agreement between asynchronous 3D-Total Body Photography based examination and dermatology clinician exam.
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A Clinical Study Of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) In People With Breast Cancer (MK-2870-032)
Scottsdale/Phoenix, AZ; Jacksonville, FL
Researchers are looking for new ways to treat types of breast cancer that are both:
* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.
Sacituzumab ...
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Venetoclax And Vincristine Liposomal In Treating Patients With Relapsed Or Refractory T-cell Or B-cell Acute Lymphoblastic Leukemia
Rochester, MN
This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine liposomal in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vincristine liposomal, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax ...
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A Study Of 3-D Digital Mammography To Screen Patients For Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate digital tomosynthesis (3-D) mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
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Retroperitoneal Lymph Node Dissection In Treating Patients With Testicular Seminoma
Rochester, MN
This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in the body behind the intestines that is typically the first place that seminoma spreads. RPLND is a surgery that removes lymph nodes in this area to treat testicular seminoma and may experience fewer long-term toxicities, such as a second cancer, cardiovascular disease, metabolic syndrome (pre-diabetes), or lung disease.
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A Study Of Using Palbociclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone For Hormone Receptor Positive/ Human Epidermal Growth Factor Receptor 2 Negative Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer to determine whether the addition of palbociclib will improve outcomes over endocrine therapy alone.
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Study To Evaluate Microbiome Composition And Diversity Signature Using Endoscopic Ultrasound
Rochester, MN
The specific aims of this study are as follows:
Aim # 1: To determine the prevalence of pancreas solid tumor intratumoral microbiota, their composition and diversity in specimens prospectively acquired via endoscopic ultrasound (EUS).
Aim # 2: To investigate both the oral and duodenal microbiome of such patients to evaluate for similarities and differences.
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A Study To Evaluate Nutrition Therapy In Improving Immune System In Bladder Cancer Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
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A Study Of Carboplatin, Cabazitaxel And Abiraterone In High Volume Metastatic Castration Sensitive Prostate Cancer (CASCARA)
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine the proportion of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria 1 year, with 6 cycles of carboplatin and cabazitazel followed by continued abiraterone.
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Electron Beam Intraoperative Radiation Therapy Following Chemoradiation In Patients With Pancreatic Cancer With Vascular Involvement (PACER)
Jacksonville, FL; Rochester, MN
The purpose of this study is to to evaluate the rate of overall survival (OS) at two years in patients with either borderline or locally advanced pancreatic cancer who receive electron beam intraoperative radiation therapy (IORT) following chemotherapy and radiation therapy.
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Trial Of Educational Modification Sessions And Sunless Tanner AS A Method Of Reducing The Incidence Of Tanning Bed Use In Young Adults
Rochester, MN
This phase II four armed factorial randomized clinical trial will look at tanning bed use reduction in the setting of skin cancer directed educational sessions in young adults with frequent tanning bed use. It is hoped that the experimental treatment of education sun safety sessions and free sunless tanner samples will be successful in decreasing the mean frequency of tanning bed use. In addition to tanning bed use reduction, this trial will also determine tanning bed use abstinence and compare the frequent application of sun screen in addition to other healthy habits among participants.
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Long-Term Safety Of Lutetium (177Lu) Vipivotide Tetraxetan In Participants With Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other serious adverse reaction(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.
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Ultrasound-Guided Core Needle Biopsy To Stage Urothelial Carcinoma Of The Bladder (US UCB)
Rochester, MN
This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).
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A Study To Assess Naporafenib (ERAS-254) Administered With Trametinib In Patients With NRAS-mutant Melanoma (SEACRAFT-2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to select the optimal dose of naporafenib + trametinib to be studied in Stage 2 and to compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).
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Bladder Bank (A Prospective Banking Study)
Rochester, MN
The purpose of this study is to establish samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer
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Claudin18.2 CAR-T (CT041) In Patients With Gastric, Pancreatic Cancer, Or Other Specified Digestive Cancers
Rochester, MN
A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
La Crosse, WI
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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Optical Fusion Trans-Perineal Grid
Rochester, MN
The purpose of this study is to evaluate and assess a new perineal access tool to enable image guided prostate interventions by Clear Guide Medical in collaboration with the Mayo Clinic.
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Testosterone in Treating Postmenopausal Patients with Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Mankato, MN
RATIONALE: Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.
PURPOSE: This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia caused by anastrozole or letrozole.
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Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor at 3 years.
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Treating Patients with Stage III Colon Cancer Previously Treated with Surgery
Eau Claire, WI
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin ...
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A Study to Establish a Living Breast Organoid Biobank for Translational Research
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Researchers at Mayo Clinic are developing a Biobank of adult stem cell-rich breast organoids, a new research resource to facilitate normal and cancer stem cell research. Subjects in the Biobank will provide samples of excess breast tissue, complete a health questionnaire, and allow access to medical records now and in the future. The Biobank serves as a library for researchers; instead of having to look for volunteers for each new project, researchers can use samples from the Biobank as well as share information already collected.
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A Study Of Ifinatamab Deruxtecan In Subjects With Pretreated Advanced Or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Scottsdale/Phoenix, AZ; Rochester, MN
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).
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Assessing Breast Cancer Risk Perception In Hispanic, Black, And Black Hispanic Women
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to understand how women of color from diverse racial and ethnic backgrounds conceptualize their current and lifetime risk for breast cancer (BC) and to identify which risk factors most resonate with perceptions of BC risk.
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Bemarituzumab Or Placebo Plus Chemotherapy In Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main objective of this study is to compare effectiveness of bemarituzumab combined with oxaliplatin and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).
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A Study Assessing DNA Markers For The Detection Of Pancreatic Cancer And Precancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess DNA markers in pancreatic juice and stool for the detection of pancreatic cancer and precancer.
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Database of All Patients with Peritoneal Surface Malignancies Treated at Mayo Clinic
Rochester, MN
The purpose of this study is to:
- Establish a prospective database of all patients with peritoneal surface malignancies seen by Dr. Travis Grotz at the Mayo Clinic, Rochester.
- Design and implement quality improvement projects utilizing this database
- Design and implement outcomes research using this prospective database
- Design and implement quality of life studies using this prospective database
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Profiling of Blood Immune Biomarkers in Bladder Cancer
Rochester, MN
The purpose of this study is to characterize the immune markers of granulocytes, lymphocytes and monocytes in peripheral blood of newly diagnosed bladder cancer patients.
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Histology of Functional Density in Premenopausal Breast
Rochester, MN
The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.
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Early Detection In Those With Hereditary Cancer Predisposition
Scottsdale/Phoenix, AZ
The purpose of this stduy is to develop early cancer detection markers in these high risk genetically predisposed populations we require three things:
a) Clinical phenotype of patients with hereditary cancer pedispositon syndromes
b) Longitudinal biospecimen collection that can be utilzied for ct-DNA analysis
c) Next generation sequencing including nucleir acid sequencing of cell free DNA and RNA, genomic DNA, messenger RNA and fragmentomics analysis.
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Phase III Study To Assess AZD9833+ CDK4/6 Inhibitor In HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
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Black Prostate Cancer Survivors
Jacksonville, FL
The purpose of this study is to investigate the experiences and challenges faced by Black men in their journey of surviving prostate cancer. By exploring various aspects of survivorship, including physical, emotional, and social dimensions, this research aims to provide valuable insights into the unique needs of this population and inform the development of targeted support interventions.
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A Study To Detect Prostate Cancer Extraprostatic Extension With Slip Interface Imaging Determined Tumor Slip Length
Rochester, MN
The purpose of this study is to evaluate the perfomance a MR-based imaging technology (named Slip Interface Imaging) in predicting extraprostatic extension in prostate cancers.
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64Cu-SAR-bisPSMA And 67Cu-SAR-bisPSMA For Identification And Treatment Of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Rochester, MN
The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
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Standard Or Comprehensive Radiation Therapy In Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy And Surgery
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.
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A Study To Evaluate Whether Participants With Melanoma Prefer Subcutaneous Vs Intravenous Administration Of Nivolumab And Nivolumab + Relatlimab Fixed-dose Combinations
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.
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Prostate Cancer Cell Lines Using Biopsies Of Early Stage Prostate Cancer Patients And Research On Cancer Mechanisms Through Its Genes And Proteins
Rochester, MN
The purpose of this study aims to establish a total of 30 new primary prostate cancer cell lines using a portion of biopsy tissue from early-stage prostate cancer patients and to collect protein characterization data showing high expression for each cell line. The primary objective is to discover specific genes and proteins that show excessive expression differences in each group of prostate cancer cell lines. The specific genes and proteins obtained here will be used to find customized anticancer candidates for prostate cancer patients in the future. As a final objective, we aim to build a new classification of existing ...
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Etiology, Prevention And Therapy Navigation Of Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in “real world” practice conditions.
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Testing The Effect Of M1774 On Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and who have a mutation in the speckle type BTB/POZ protein (SPOP) gene. M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study Of Intravesical BCG In Combination With ALT-803 In Patients With Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
For Cohort A, the purpose of this study is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with CIS disease (with or without Ta/T1) in terms of complete response (CR) rate using cystoscopy, confirmatory bladder biopsy, and urine cytology. For Cohort B, the purpose is to determine the effectiveness of the combination of N-803 plus BCG compared to BCG alone in patients with high-grade papillary disease (Ta/T1 only) in terms of disease-free survival (DFS) using cystoscopy, confirmatory bladder biopsy, and urine cytology.
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Kinetics Of Troponin And BNP In Breast Cancer Chemotherapy With Adriamycin And Trastuzumab
Jacksonville, FL
This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have ...
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Plasma Proneurotensin As A Predictive Biomarker For Breast Cancer In Genetically Predisposed Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether elevated fasting plasma proneurotensin levels are common in patients genetically predisposed to breast cancer.
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Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) In Patients With Metastatic Pancreatic Adenocarcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of a specific treatment regimen (protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN)) combined with a device called Tumor Treatment Fields (TTF) in preventing tumor growth in paitents with recurrent recurrent and/or metastatic pancreatic cancer (met-PC).
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An Investigational Immuno-therapy Study Of Nivolumab, Compared To Placebo, In Patients With Bladder Or Upper Urinary Tract Cancer, Following Surgery To Remove The Cancer
Rochester, MN
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
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Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers
No Locations
This randomized phase I trial studies the side effects and best dose of linaclotide acetate in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal cancer.
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Colorectal Cancer Screening In Black And Underserved Communities In The Phoenix Metro Area
Scottsdale/Phoenix, AZ
The aims of this study are to increase the number of Black consultants at MCA, make a meaningful impact on interactions among staff, leadership, and patients, and increase the number of Black staff in leadership roles beyond Diversity and Inclusion efforts.
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A Study of Pre-Surgery Inspiratory Muscle Training for Patients who will have Surgery on Their Esophagus
Rochester, MN
The purpose of this study is to get definite evidence for the effectiveness of a short preoperative inspiratory muscle training protocol on the level of sickness and recovery of patients who are having the surgical removal of a portion of the esophagus.
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Determining Molecular Drivers of Radiation Dermatitis
Jacksonville, FL
The purpose of this study is to collect (i) pre-treatment (at the time of breast cancer surgery) normal skin and (ii) on-treatment (around the third week of treatment with breast radiation) irradiated skin with clinical hallmarks of radiation dermatitis (erythema and/or dry desquamation, documented by a photograph and graded by clinical criteria).
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Three-Dimensional Ultrasound in the Determination of Tumor Volume and Myometrial Invasion in Endometrial Cancer
Rochester, MN
The purpose of this study is to evaluate sensitivity and specificity of 3D ultrasound in the assessment of tumor diameter and myometrial invasion in endometrial cancer in a pre-operative setting. This research is aiming to avoid the performance of sentinel node biopsy in patients at low risk of lymphatic spread.
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Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal ...
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A Study Of Single Patient Investigational Drug CPI-613 For Use In Treatment-Refractory, Metastatic Prostate Cancer
Rochester, MN
This is a single patient study of an investigational drug CPI-613 for treatment of metastatic prostate cancer.
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Trial Of Nadofaragene Firadenovec Vs. Observation In Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
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A Study Of A Mindfulness-Based Intervention With A Wearable Wellness Brain Sensing Device In Newly Diagnosed Breast Cancer Patients Undergoing Surgery
Rochester, MN
The purpose of this study is to determine the usefulness and effectiveness of Muse, a brain sensing headband intervention, to affect quality of life, stress, fatigue and sleep in newly diagnosed breast cancer patients who are undergoing surgical treatment.
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Defining Meaningful Within-Patient Change In Symptoms Of Advanced Cancer Patients
Rochester, MN
The purpose of this study is to define meaningful change in symptoms and physical function for advanced cancer patients receiving treatment.
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Targeted Imaging Of Melanoma For Alpha-Particle Radiotherapy
Rochester, MN
The purpose of this study is to determine safety and measure biodistribution of two imaging agents in patients with refractory or metastatic melanoma. This study will use [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) imaging.
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A Study to Evaluate the Effects of Exercise on Fatigue in Thyroid Cancer Survivors
Rochester, MN
The purpose of this study is to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients, and to determine the effect of a home-based program compared to a center- based program.
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A Study to Evaluate Same Day Discharge Post-mastectomy with/without Alloplastic Breast Reconstruction
Rochester, MN
In the light of the pandemic, institutions have had to take greater precautions and instigate procedures to aim to improve safety and reduce risk for patients undergoing surgery. One intiative was designed to implement a same day discharge for patients undergoing mastectomy with or without alloplastic reconstruction. This study aims to evaluate the outcomes and patient satisfaction with same day mastectomy with or without alloplastic reconstruction following COVID-19 and compare satisfaction and outcomes (e.g complications) with patients pre-COVID 19. This is part of a quality improvement project.
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A Study Of Response Rate And Survival From Combined Chemotherapy, Surgery And Radiation Therapy For Patients With Malignant Mesothelioma
Rochester, MN
The purpose of this study is to follow patients with malignant mesothelioma of the lung after they have had combined chemotherapy, surgery, and intensity modified radiation therapy and determine response rates and overall survival.
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A Study Of The Bacteria Found In Cancerous And Non-cancerous Breast Tissue
Rochester, MN
The purpose of this study is to see if having different kinds of bacteria genes in breast tissue may be connected to the risk of getting breast cancer.
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Pembrolizumab in Treating Patients With Locally Advanced Bladder Cancer
Eau Claire, WI; Scottsdale/Phoenix, AZ; La Crosse, WI
This randomized phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study In Lung (DELFI-L201)
Rochester, MN
The purpose of this study is to determine the sensitivity and specificity of a blood test (DLCST) for the detection of lung cancer in a screening setting using the reference of Chest CT screening and a histologic diagnosis of lung cancer.
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Changes In GI Inflammation And The GI Microbiome Profile In Women With Breast Cancer Throughout Chemotherapy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy. Also, to examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy.
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Photoradiation With Verteporfin To Facilitate Immunologic Activity Of Pembrolizumab In Unresectable, Locally Advance Or Metastatic Pancreatic Cancer
Rochester, MN
We will study the effects of photodynamic priming for pancreatic adenocarcinoma treatment. Prior to study treatment, the patient will undergo photodynamic therapy using endoscopic ultrasound or CT-guided fine needle aspirate to directly target the tumor. After recovery from the procedure, the patient will start pembrolizumab. These steps are hoped to enhance the effect of standard chemotherapy given to eradicate the tumor.
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Study Of Quemliclustat And Chemotherapy Versus Placebo And Chemotherapy In Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.
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Integration Of Fluid Integration Of Fluid And Imaging-Based Markers For Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to refine the current diagnostic algorithm and improve the pre-biopsy detection of high-grade prostate cancer by 1) identifying patients with high-grade prostate cancer who may receive a negative MRI and 2) avoiding MRI and biopsy in men with benign disease and indolent prostate cancer.
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Imaging Of Prostatic Anatomy In Patients With Known Prostate Cancer And Those At High-Risk Using Magnetic Resonance Elastography
Rochester, MN
Many of the current imaging tests we have for prostate cancer are problematic in their ability to distinguish cancerous from non-cancerous prostate tissue. This study is being performed to develop better imaging techniques to better identify and characterize prostate cancer.
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Dose Escalation And Expansion Study Of GSK525762 In Combination With Fulvestrant In Subjects With Estrogen Receptor Positive (ER+) Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded ...
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First-in-Human Study Of KO-947 In Non-Hematological Malignancies
Rochester, MN
This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity.
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Screening For High Frequency Malignant Disease
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.
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Focal Prostate Ablation Utilizing TULSA Profound System
Rochester, MN
The primary hypotheses are that the TULSA-Procedure is safe and effective treatment of intermediate grade prostate cancer over 2 years. The primary endpoint is defined as the proportion of patients who maintain urinary continence and erectile potency. The effectiveness co-primary endpoint is defined as the proportion of patients free from treatment failure.
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Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) For The Local Staging Of Rectal Cancer
Rochester, MN
This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.
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A Multi-Center Trial Of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition And Stereotactic Body Radiotherapy In Prostate Cancer (ASCLEPIuS)
Rochester, MN
The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (phase 2 portion of the study).
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A Study Of ANV419 Alone Or In Combination With Approved Treatment In Patients With Cutaneous Melanoma (OMNIA-1)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma.
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Evaluation Of F-18 Tetrafluoroborate (18F-TFB) PET/CT In Patients With Differentiated Thyroid Cancer
Rochester, MN
The purpose of this study is to investigate radiotracer 18F-tetrafluoroborate (18F-TFB) for imaging of patients with differentiated thyroid cancer
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Blood And Urine Identification Of Methylated DNA Markers In Invasive Bladder Carcinoma
Rochester, MN
The purpose of this study is to, in tissue, discover and validate DNA methylation markers (MDMs) for detection of invasive urothelial carcinoma of the bladder. In blood, to assess the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. In urine, to explore the accuracy of candidate MDMs from above for detection of invasive urothelial carcinoma of the bladder. Diagnostic accuracy on urine can be compared with that on plasma using paired samples.
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A Study To Analyze Isolation, Activation And Expansion Of Mutation Reactive T-cells
Rochester, MN
The purpose of this study is to examine the ease and practicality of extracting central memory T-cells and the potential for their activation and ability to recognize tumor antigens and target lung cancer cells for destruction. Circulating cell-free DNA (cfDNA) from the plasma will be extracted and sequenced to identify somatic mutations that were exposed to the T-cells.
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Higher Per Daily Treatment-Dose Radiation Therapy Or Standard Per Daily Treatment Radiation Therapy In Treating Patients With Early-Stage Breast Cancer That Was Removed By Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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A Study To Evaluate DNA Evaluation Of Fragments For Early Interception - Lung Cancer Training Study
Rochester, MN
The purpose of this study is train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.
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Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, Phase 1b/2 trial. The purpose of phase 1b part of the trial aims to determine the recommended phase II dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the effectiveness and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
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MC1R-targeted Alpha-particle Monotherapy And Combination Therapy Trial With Nivolumab In Adults With Advanced Melanoma
Jacksonville, FL; Rochester, MN
In this first-in human, phase I/IIa study, the safety and efficacy of \[212Pb\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with Nivolumab in subjects with unresectable and metastatic melanoma.
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A Study Of Single Patient Investigational Drug CPI-613 For Use In Treatment-Refractory, Metastatic Prostate Cancer
Rochester, MN
This is a single patient study of an investigational drug CPI-613 for treatment of metastatic prostate cancer.
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Trial Of Nadofaragene Firadenovec Vs. Observation In Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
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A Study Of A Mindfulness-Based Intervention With A Wearable Wellness Brain Sensing Device In Newly Diagnosed Breast Cancer Patients Undergoing Surgery
Rochester, MN
The purpose of this study is to determine the usefulness and effectiveness of Muse, a brain sensing headband intervention, to affect quality of life, stress, fatigue and sleep in newly diagnosed breast cancer patients who are undergoing surgical treatment.
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Defining Meaningful Within-Patient Change In Symptoms Of Advanced Cancer Patients
Rochester, MN
The purpose of this study is to define meaningful change in symptoms and physical function for advanced cancer patients receiving treatment.
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Pembrolizumab in Treating Patients With Locally Advanced Bladder Cancer
Eau Claire, WI; Scottsdale/Phoenix, AZ; La Crosse, WI
This randomized phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
-
Dose Escalation And Expansion Study Of GSK525762 In Combination With Fulvestrant In Subjects With Estrogen Receptor Positive (ER+) Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded ...
-
First-in-Human Study Of KO-947 In Non-Hematological Malignancies
Rochester, MN
This phase 1 first-in-human (FIH) dose escalation study will determine the maximum tolerated dose (MTD) of KO-947 in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancies. If an MTD cannot be identified, a recommended phase 2 dose (RP2D) will be determined. In addition, two tumor specific extension cohorts may be conducted to further characterize the safety and tolerability of KO-947 and provide preliminary evidence of anti-tumor activity.
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MARK 1A Series: Percutaneous Microwave Ablation For Patients With Lung Tumor(s)
Rochester, MN
The purpose of this study is to evaluate if lung ablation improves clinical outcomes for patients deemed to be surgically high-risk.
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Study Of Quemliclustat And Chemotherapy Versus Placebo And Chemotherapy In Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.
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Integration Of Fluid Integration Of Fluid And Imaging-Based Markers For Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to refine the current diagnostic algorithm and improve the pre-biopsy detection of high-grade prostate cancer by 1) identifying patients with high-grade prostate cancer who may receive a negative MRI and 2) avoiding MRI and biopsy in men with benign disease and indolent prostate cancer.
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Imaging Of Prostatic Anatomy In Patients With Known Prostate Cancer And Those At High-Risk Using Magnetic Resonance Elastography
Rochester, MN
Many of the current imaging tests we have for prostate cancer are problematic in their ability to distinguish cancerous from non-cancerous prostate tissue. This study is being performed to develop better imaging techniques to better identify and characterize prostate cancer.
-
Screening For High Frequency Malignant Disease
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations.
-
Focal Prostate Ablation Utilizing TULSA Profound System
Rochester, MN
The primary hypotheses are that the TULSA-Procedure is safe and effective treatment of intermediate grade prostate cancer over 2 years. The primary endpoint is defined as the proportion of patients who maintain urinary continence and erectile potency. The effectiveness co-primary endpoint is defined as the proportion of patients free from treatment failure.
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Contrast-Enhanced Photon-Counting Detector CT (PCD-CT) For The Local Staging Of Rectal Cancer
Rochester, MN
This study evaluates whether images taken using a photon counting detector CT scanner (PCD-CT) can determine the growth of rectal cancer as well as, or better than, MRI for the management of patients with rectal cancer.
-
A Multi-Center Trial Of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition And Stereotactic Body Radiotherapy In Prostate Cancer (ASCLEPIuS)
Rochester, MN
The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (phase 2 portion of the study).
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A Study Of ANV419 Alone Or In Combination With Approved Treatment In Patients With Cutaneous Melanoma (OMNIA-1)
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma.
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Higher Per Daily Treatment-Dose Radiation Therapy Or Standard Per Daily Treatment Radiation Therapy In Treating Patients With Early-Stage Breast Cancer That Was Removed By Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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A Study To Evaluate DNA Evaluation Of Fragments For Early Interception - Lung Cancer Training Study
Rochester, MN
The purpose of this study is train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.
-
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, Phase 1b/2 trial. The purpose of phase 1b part of the trial aims to determine the recommended phase II dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the effectiveness and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
-
MC1R-targeted Alpha-particle Monotherapy And Combination Therapy Trial With Nivolumab In Adults With Advanced Melanoma
Jacksonville, FL; Rochester, MN
In this first-in human, phase I/IIa study, the safety and efficacy of \[212Pb\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with Nivolumab in subjects with unresectable and metastatic melanoma.
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Evaluating Bladder CARE™, A New Non-Invasive Urine Test, For Bladder Cancer Detection In Inconclusive Cases
Rochester, MN
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:
• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?
Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), ...
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Melanoma Relatlimab Nivolumab
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that has spread
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A Study To Evaluate The Safety Of Lasofoxifene In Combination With Abemaciclib In Advanced Or Metastatic ER+/HER2− Breast Cancer With ESR1 Mutation
Jacksonville, FL; Rochester, MN
The purpse of this study is to evaluate the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
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Cancer Prevention: Stories For Change In Hispanic Community
Rochester, MN
This study is a process evaluation of a digital storytelling (DST) intervention. Because the DST intervention has not yet been developed, it is appropriate to use qualitative methods to assess the process.
This study will recruit gifted storytellers for a digital storytelling intervention on breast, cervical, and colorectal cancer. A digital storytelling intervention will be developed to improve breast, cervical, and colorectal cancer screening rates among Hispanic, Spanish speaking individuals. Additionally, to conduct a qualitative assessment of the digital storytelling workshop.
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Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility
Scottsdale/Phoenix, AZ
The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.
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Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures after Endotherapy
Jacksonville, FL
Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and early esophageal cancers. However, esophagectomy is associated with significant morbidity and mortality. With the advance of therapeutic endoscopy, there has been a growing interest and application of endoscopic resection and mucosal ablative techniques for the treatment of these diseases. Esophageal stricture(ES) formation has become an increasingly recognized complication of extensive endoscopic mucosal ablation and/or resection. The resultant symptomatic stricture development can significantly impair a patient's quality of life. Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid injection is invasive, costly, and associated with the potential ...
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A Study to Collect Survival Data on Patients Previously Enrolled in Abraxane Pancreatic Cancer Study CA046.
Scottsdale/Phoenix, AZ
A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.
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Letrozole After Tamoxifen in Treating Women With Breast Cancer
La Crosse, WI
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
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Pulmonary Rehabilitation Before Lung Cancer Resection
Jacksonville, FL; Rochester, MN
This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).
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A Study of Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
Rochester, MN
The purpose of this study is to evaluate the effects of treating pancreas cysts that connect with the main pancreas duct with injected ethanol using endoscopic retrograde cholangiopancreatography (ERCP) and/or endoscopic ultrasound. Past studies have excluded these cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol.
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Rochester, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
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Advancing Survivorship Support Through Virtual Health Equity Resources For Breast Cancer Responsive Education
Jacksonville, FL
The purpose of the HERCaRE study aims to pilot and evaluate a virtual navigation and support platform for Black breast cancer survivors within the Mayo Clinic Comprehensive Cancer Center Florida catchment area. This study will assess the usability, acceptability, and engagement of participants with the HERCaRE platform, which provides culturally tailored educational content. By leveraging mobile technology, HERCaRE seeks to address gaps in supportive care and empower survivors to take an active role in their health management. This study will involve recruiting adult Black breast cancer survivors who are willing to engage with the platform and provide feedback through bi-weeklys surveys, ...
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Melanoma In-transit Tissue Bank And Molecular Analysis For Personalized Therapies
Jacksonville, FL; Rochester, MN
The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy. Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.
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A Study Of Three-dimensional (3-D) Tissue Models In Patients With Serous Endometrial Cancer Planning To Undergo Surgery
Jacksonville, FL; Rochester, MN
The purpose of this research study is to learn more about serous endometrial cancer by creating three-dimensional (3-D) tissue models in the laboratory setting. The tissue models will provide scientists with a reliable, sensitive method to test biomarkers and cellular responses to treatment for endometrial cancer.
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Understanding The Resistance To Enzalutamide In Patients With Castrate Resistant Metastatic Prostate Cancer
Jacksonville, FL
We are checking for circulating tumor cells at baseline, one month and at progression of disease
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Treatment Of Multifocal Lung Adenocarcinoma
Rochester, MN
To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.
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Cervical Cancer Screening Barriers
Rochester, MN
The purpose of this study is to determine barriers that may hinder cervical cancer screening rates across the health system so processes can be employed more broadly to improve screening rates.
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A Study For Early Detection Of Lung Cancer And Lung Disease Utilizing Sputum
Rochester, MN
The purpose of this study is to develop a simple test for early and accurate detection of lung cancer and lung disease.
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Evaluating The Association Of Inflammatory Response To Intestinal Leakage In Patients Receiving Chemotherapy For Stage 3 Colon Cancer
Rochester, MN
To study intestinal permeability in participants with stage 3 colon cancer before and during chemotherapy and compare with controls with normal colon, chronic ulcerative colitis (CUC) and carcinoid syndrome
To study the correlation between intestinal permeability and symptoms severity during 5-FU chemotherapy
To study the correlation between intestinal permeability and neutrophils to lymphocytes ratio (NLR) before and during chemotherapy
To analyze the changes in expression levels of genes encoding intercellular junction proteins in all groups
To determine if diarrhea in participants with carcinoid syndrome is associated with increasedintestinal permeability
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I-SPY TRIAL: Neoadjuvant And Personalized Adaptive Novel Agents To Treat Breast Cancer (I-SPY)
Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Identifying Pancreatic Cancer Risk Factor In Electronic Medical Records Using Natural Language Processing Algorithms
Rochester, MN
The objective of this study is to measure real-world recall and precision of Natural Language Processing (NLP) algorithms in identifying the presence of known risk factors for Pancreatic (PDAC) in a defined primary care population using unstructured clinical notes.
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Diet in Altering Disease Progression in Patients with Prostate Cancer on Active Surveillance
Rochester, MN
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
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S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery
Rochester, MN
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.
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Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Albert Lea, MN; Eau Claire, WI; Mankato, MN; Jacksonville, FL; Rochester, MN; La Crosse, WI
This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better ...
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ZTE MRI For Visualization Of Bone Cement, Breast Biopsy Markers
Rochester, MN
The purpose of this study is to demonstrate that ZTE allows for better visualization of bone cement breast biopsy markers when compared to conventional breast biopsy markers and pulse sequences.
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Testing Whether The Addition Of Carboplatin Chemotherapy To Cabazitaxel Chemotherapy Will Improve Outcomes Compared To Cabazitaxel Alone In People With Castrate-Resistant Prostate Cancer That Has Spread Beyond The Prostate To Other Parts Of The Body
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN
The purpose of this study compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of ...
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PKCι & MTOR Inhibition With Auranofin+Sirolimus For Squamous Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The primary purpose of this study is to find out what effects (good or bad) the drugs auranofin and sirolimus have on patients with lung cancer; to find out if auranofin and sirolimus can stop or slow the growth of the lung cancer; to learn more about how auranafin and sirolimus work against lung cancer by testing blood and tissue samples.
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A Study To Evaluate Non-Operative Management And Early Response Assessment In Rectal Cancer
Rochester, MN
The purpose of this study is to determine if the complete clinical response rate of patients with Stage I-IIIB (cT1-3, N0-1, M0) rectal cancer being treated with sequential short course radiotherapy followed by multi-drug chemotherapy is greater than 50%.
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Expanded Access Ga68 PSMA PET Imaging
Rochester, MN
The primary objective of this study is to provide access to [Ga-68] PSMA-11 imaging (PET/CT or PET/MR) for patients diagnosed with untreated high-risk prostate cancer or biochemically recurrent prostate cancer.
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Testing Olaparib For One Or Two Years, With Or Without Bevacizumab, To Treat Ovarian Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5\'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib ...
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Comprehensive Genetic Assessment, Risk And Education In A Mammography Pilot
Scottsdale/Phoenix, AZ
Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.
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A Study To Evaluate DS-8201a Combined With Olaparib In HER2-Expressing Cancers With Expansion In Endometrial Cancer Patients
Testing The Combination Of DS-8201a And Olaparib In HER2-Expressing Cancers With Expansion In Patients With Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of the combination of DS-8201a in combination with olaparib, and to determine the recommended phase 2 dose (RP2D) 1.1.2 To evaluate the safety and tolerability of this combination in a dose expansion cohort in patients with uterine serous carcinoma.
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Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction
Rochester, MN
This phase I trial studies the side effects and the best dose of dabrafenib in treating patients with solid tumors and kidney or liver dysfunction. Dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Study to Evaluate Effects of Pre-Surgery Therapy on Direct-to-Implant Reconstruction as Compared to Immediate Tissue Expander-Based Reconstruction
Rochester, MN
The purpose of this study is to compare and identify different forms/regimens of chemotherapy/hormone therapy in breast cancer patients who underwent mastectomy and subsequent immediate breast reconstruction (tissue expander or direct-to-implant). Subsequently, correlate these findings to assess overall surgical and clinical outcomes.
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Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Scottsdale/Phoenix, AZ; Rochester, MN
This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference ...
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A Study to See if the Depth of Tumor Invasion of Esophageal Carcinoma Predicts Lymph Node Involvement and Cancer Free Survival
Rochester, MN
The purpose of this study is to see if different depths of submucosal tumor invasion in esophageal cancer can predict lymph node involvement and survival.
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Family Cancer Literacy to Promote Mammography Screening among Navajo Women
Rochester, MN
The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.
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High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.
PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.
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GENetic Risk Estimation Of Breast Cancer Prior To Decisions On Preventive Therapy Uptake, Risk Reducing Surgery Or Intensive Imaging Surveillance
Albert Lea, MN; Scottsdale/Phoenix, AZ; Austin, MN; Jacksonville, FL; Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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Abiraterone/Prednisone, Olaparib, Or Abiraterone/Prednisone + Olaparib In Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
Rochester, MN
This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.
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Imiquimod And Pembrolizumab In Treating Patients With Stage IIIB-IV Melanoma
Jacksonville, FL
This pilot trial studies the side effects and how well imiquimod and pembrolizumab work in treating patients with stage IIIB-IV melanoma. Imiquimod may stimulate the immune system. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving imiquimod and pembrolizumab may work better at treating melanoma.
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Proton-Based Stereotactic Ablative Body Radiotherapy For Prostate Cancer
Rochester, MN
Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is a specialized form of radiotherapy used to treat prostate cancer with five treatments over two weeks, compared with a conventional eight-week or longer treatment course. The purpose of this trial is to investigate the effect that proton-based SABR has on quality-of-life in patients with localized prostate cancer. The evaluation and treatment will otherwise follow standard of care, and is not considered investigational.
Patients undergo evaluation and medical care in the same way that they would if they were not part of this trial. This may include standard of ...
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Measuring Cell Free DNA During The Course Of Treatment For Esophageal Cancer As A Marker Of Response And Recurrence
Rochester, MN
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.
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A Study to Evaluate the Safety of the Goldilocks Procedure with Implant-Based Reconstruction
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess outcomes, satisfaction and aesthetics of two different breast reconstruction techniques (Goldilocks alone, and Goldilocks with Implant-Based Reconstruction) and compare its safety, patient satisfaction, aesthetic evaluation and complications.
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A Study Of Movement And Memory After Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to identify disparities in the effectiveness of a 6-month, community-based aerobic exercise intervention for improving neurocognitive function in Hispanic BCS (N=40) when compared with non-Hispanic White BCS in the partner trial.
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A Study to Evaluate MRI-guided Cryoablation for Focal Native Intermediate Grade Prostate Cancer
Rochester, MN
The purpose of this study is to investigate MR-guided cryoablation of biopsy proven Gleason 7 prostate cancers using the Galil MR-compatible cryoablation system to monitor the technqiue and prospectively collect the data. The system is already FDA (510k) approved for soft tissue ablation and has been utilized successfully at Mayo previously.
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Diagnostic 68Ga-PSMA-11 PET/CT
Rochester, MN
The purpose of this study is the diagnostic 68Ga-PSMA-11 PET/CT imaging for screening prior to consideration of 177Lu-PSMA-617 therapy.
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Long Term Outcomes In Pancreas Cancer Patients
Rochester, MN
The purpose of this study is to access long-term quality of life, complications, and implications of treatments on patients who are long-term survivors of pancreas cancer and were treated at Mayo Clinic.
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A Study To Create A Registry For Patients At High-Risk For Pancreatic Cancer
Rochester, MN
This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC). and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.
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A Study To Evaluate Radiotherapy To The Whole Breast Or Post-mastectomy Chest Wall Including Regional Nodal Irradiation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.
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A Study Of Pancreatic Cancer Risk
Rochester, MN
The primary purpose of this study is to develop a cohort (biobank of biospecimens and data) of individuals aged 50 and older without pancreatic cancer who are members of kindreds containing three blood relatives with pancreatic cancer, OR who carry a mutation in a known predisposition gene for pancreatic cancer.
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A Study To Analyze Symptoms And Quality Of Life Issues In Women Living With Metastatic Breast Cancer
Jacksonville, FL
The purpose of this study is to gain an understanding of the lived experiences of symptoms and quality of life issues experienced by women with metastatic breast cancer.
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Monitoring Body Composition Changes In High Risk Patients For Pancreatic Cancer (PDAC)
Jacksonville, FL
The purpose of this research is to monitor body composition changes with wearable devices in patients who have been identified as high risk for developing pancreatic cancer (PDAC).
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Robotic Vs. Open NSM For Early Stage Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
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Endometrial Cancer/Endometrial Atypical Hyperplasia With An AI-based Classifier In Transvaginal Ultrasound In Patients With Post-Menopausal Bleeding
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to prospectively validate a new Artificial Intelligence (AI)-based model developed by our team to analyze TVUS images for early EC detection.
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Genetic Testing With Family History Of Pancreatic Cancer
Jacksonville, FL
The purpose of this study is perform HOUSES index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria. A subset of 40 patients, who did not have appropriate NCCN intervention (the opportunity to have a genetic consultation to consider genetic testing) will prospectively be offered this opportunity. This subset of patients will also be surveyed on their family hisotry and knowledge and experiences of genetic consults/testing to better understand their decision-making when offered genetic counseling and testing.
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A Study To Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT In Men With Hormone Sensitive Prostate Cancer And Raise Of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if darolutamide plus ADT given for 12 months improves rPFS by PSMA PET/CT compared with placebo plus ADT given for 12 months, and to further evaluate efficacy and to measure the treatment impact on patients’ quality of life, and to assess the safety of darolutamide plus ADT compared with placebo plus ADT.
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A Collaborative Intervention For Improving Cancer Pain Management In Rural And Hispanic Cancer Survivors (ASCENT)
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially well matched for these patients, and can ...
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Pazopanib In Treating Patients With Metastatic Non-Clear Cell Kidney Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well pazopanib hydrochloride works in treating patients with metastatic kidney cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of kidney cancer by blocking blood flow to the tumor.
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Optimizing Pancreatic Cancer Management Using Next Generation Imaging And Liquid Biopsy
Rochester, MN
The purpose of this study is to examine the relationship of ctDNA status and FDG PET/MRI findings with other clinicopathologic variables and standard staging examinations. We will develop a multivariable model combining ctDNA and FDG PET/MRI biomarkers to predict treatment response and survival. In addition, we will define the quantitative thresholds for early chemotherapy switch in patients who do not respond to first-line chemotherapy.
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A Study To Assess Dynamic Changes In Plasma Proteome To Identify Early Detection And Treatment Response Biomarkers For HGSOC
Rochester, MN
This study aims to identify candidate High Grade Serous Cancer (HGSC) early detection and chemotherapy treatment response biomarkers. For the purpose of this study we define high grade serous cancers to include invasive cancers arising in the ovary and/or fallopian tubes (FT). Using mass spectrometry we will deeply profile and quantitate dynamic changes in the plasma proteome and N-gylcocapture sub-proteome that occur as a consequence of surgical debulking and platinum-based chemotherapy.
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Prostate Imaging Using MRI +/- Contrast Enhancement
Rochester, MN
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.
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Chemotherapy Alone Or Chemotherapy Plus Radiation Therapy In Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
Mankato, MN
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...
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Safety And Efficacy Study Of Intravesical Instillation Of TARA-002 In Adults With High-grade Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: ...
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Study Of Datopotamab Deruxtecan Plus Carboplatin Or Cisplatin Versus Gemcitabine Plus Carboplatin Or Cisplatin In Participants With Locally Advanced Or Metastatic Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment.
This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
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A Phase Ⅲ Study Of Rilvegostomig In Combination With Fluoropyrimidine And Trastuzumab Deruxtecan As The First-line Treatment For HER2-positive Gastric Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD-L1 CPS ≥ 1. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.
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A Study To Assess DNA Tumor Markers In Whole Blood Specimens Of Patients With Newly Diagnosed Lung Cancer
Rochester, MN
The purpose of this study is to assess Methylated DNA tumor markers distributed in blood samples of patients newly diagnosed with different types of lung cancer. The goal is to develop new blood screening tests that can identify the type and primary site of cancer.
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Rapid-Plan Knowledge-Based Planning Vs. Human-Driven Planning For Prostate Cancer Radiotherapy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) at 3 months post-radiotherapy for prostate cancer.
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Chemotherapy Combined With Immunotherapy Vs Immunotherapy Alone For Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Eau Claire, WI; Mankato, MN
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
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IL-2 Plus FOLFOX And Nivolumab For Treatment Of Peritoneal Metastases
Rochester, MN
The purpose of this study is to evaluate the reduction in the peritoneal carcinomatosis index (PCI) after completion of the study treatment.
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Vaccine Therapy Plus Pembrolizumab In Treating Advanced Ovarian, Fallopian Tube, Or Primary Peritoneal Cavity Cancer (FRAPPE)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate to the combination of folate receptor alpha dendritic cells (FRaDCs) plus pembrolizumab in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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S1011 Standard Or Extended Pelvic Lymphadenectomy In Treating Patients Undergoing Surgery For Invasive Bladder Cancer
Rochester, MN
RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.
PURPOSE: This randomized phase III trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.
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Engineering Gut Microbiome To Target Breast Cancer
Jacksonville, FL
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.
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Focal Laser Ablation Of Prostate Cancer Tumors
Rochester, MN
The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.
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Study Comparing Thin Dressings To Prevent Skin Inflammation In Breast Cancer Patients
Rochester, MN
We are doing this research study to compare radiation dermatitis severity in exposed skin protected by a thin film dressing versus skin that is not protected during radiation treatment. We will also be comparing two types of film; a perforated thin film dressing versus the standard thin film.
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Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial
Rochester, MN
The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial will determine whether systematically assessing patient reported outcomes for sleep disturbance, pain, anxiety, depression, and fatigue among patients with solid and liquid malignancies and using these data to increase the frequency of guideline-concordant care by: 1) reporting these data to their clinical teams, 2) providing patients with needs-matched symptom self-management education, and 3) suggesting evidence-based symptom management strategies to their care teams improves patients' quality of life, symptoms, and adherence to cancer treatment, while reducing their unplanned use of healthcare resources.
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A Study To Evaluate Radiation Therapy, Plasma Exchange, And Immunotherapy In Melanoma
Rochester, MN
The purpose of this study is to determine the kinetics of sPD-L1 removal and regeneration by plasma exchange in patients with melanoma.
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Testing Nivolumab And Ipilimumab With Short-Course Radiation In Advanced Rectal Cancer
Rochester, MN
The purpose of this trial is to investigate the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
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Olmsted County Healthy Skin Study
Rochester, MN
The overall goal of the Olmsted County Health Skin Study is to describe the broader community with respect to knowledge of melanoma, attitudes about tanning, perceived risk of developing melanoma, and estimated risk of developing melanoma based on participant characteristics.
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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A Study To Evaluate Radiotherapy To The Whole Breast Or Post-mastectomy Chest Wall Including Regional Nodal Irradiation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety of 5 fraction vs. 25 fraction radiation to the whole breast or post-mastectomy chest wall/reconstructed chest with regional nodal radiation.
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A Study Of Pancreatic Cancer Risk
Rochester, MN
The primary purpose of this study is to develop a cohort (biobank of biospecimens and data) of individuals aged 50 and older without pancreatic cancer who are members of kindreds containing three blood relatives with pancreatic cancer, OR who carry a mutation in a known predisposition gene for pancreatic cancer.
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A Study To Analyze Symptoms And Quality Of Life Issues In Women Living With Metastatic Breast Cancer
Jacksonville, FL
The purpose of this study is to gain an understanding of the lived experiences of symptoms and quality of life issues experienced by women with metastatic breast cancer.
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Prostate Imaging Using MRI +/- Contrast Enhancement
Rochester, MN
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.
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Chemotherapy Alone Or Chemotherapy Plus Radiation Therapy In Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
Mankato, MN
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...
-
Safety And Efficacy Study Of Intravesical Instillation Of TARA-002 In Adults With High-grade Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: ...
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Study Of Datopotamab Deruxtecan Plus Carboplatin Or Cisplatin Versus Gemcitabine Plus Carboplatin Or Cisplatin In Participants With Locally Advanced Or Metastatic Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment.
This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
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A Phase Ⅲ Study Of Rilvegostomig In Combination With Fluoropyrimidine And Trastuzumab Deruxtecan As The First-line Treatment For HER2-positive Gastric Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD-L1 CPS ≥ 1. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.
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Monitoring Body Composition Changes In High Risk Patients For Pancreatic Cancer (PDAC)
Jacksonville, FL
The purpose of this research is to monitor body composition changes with wearable devices in patients who have been identified as high risk for developing pancreatic cancer (PDAC).
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Robotic Vs. Open NSM For Early Stage Breast Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
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Endometrial Cancer/Endometrial Atypical Hyperplasia With An AI-based Classifier In Transvaginal Ultrasound In Patients With Post-Menopausal Bleeding
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to prospectively validate a new Artificial Intelligence (AI)-based model developed by our team to analyze TVUS images for early EC detection.
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Genetic Testing With Family History Of Pancreatic Cancer
Jacksonville, FL
The purpose of this study is perform HOUSES index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria. A subset of 40 patients, who did not have appropriate NCCN intervention (the opportunity to have a genetic consultation to consider genetic testing) will prospectively be offered this opportunity. This subset of patients will also be surveyed on their family hisotry and knowledge and experiences of genetic consults/testing to better understand their decision-making when offered genetic counseling and testing.
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A Study To Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT In Men With Hormone Sensitive Prostate Cancer And Raise Of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP)
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if darolutamide plus ADT given for 12 months improves rPFS by PSMA PET/CT compared with placebo plus ADT given for 12 months, and to further evaluate efficacy and to measure the treatment impact on patients’ quality of life, and to assess the safety of darolutamide plus ADT compared with placebo plus ADT.
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A Collaborative Intervention For Improving Cancer Pain Management In Rural And Hispanic Cancer Survivors (ASCENT)
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors. Cancer pain is prevalent, under-treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Digitally facilitated solutions are especially well matched for these patients, and can ...
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Chemotherapy Combined With Immunotherapy Vs Immunotherapy Alone For Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Eau Claire, WI; Mankato, MN
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
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IL-2 Plus FOLFOX And Nivolumab For Treatment Of Peritoneal Metastases
Rochester, MN
The purpose of this study is to evaluate the reduction in the peritoneal carcinomatosis index (PCI) after completion of the study treatment.
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Vaccine Therapy Plus Pembrolizumab In Treating Advanced Ovarian, Fallopian Tube, Or Primary Peritoneal Cavity Cancer (FRAPPE)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate to the combination of folate receptor alpha dendritic cells (FRaDCs) plus pembrolizumab in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.
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Pazopanib In Treating Patients With Metastatic Non-Clear Cell Kidney Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well pazopanib hydrochloride works in treating patients with metastatic kidney cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of kidney cancer by blocking blood flow to the tumor.
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Optimizing Pancreatic Cancer Management Using Next Generation Imaging And Liquid Biopsy
Rochester, MN
The purpose of this study is to examine the relationship of ctDNA status and FDG PET/MRI findings with other clinicopathologic variables and standard staging examinations. We will develop a multivariable model combining ctDNA and FDG PET/MRI biomarkers to predict treatment response and survival. In addition, we will define the quantitative thresholds for early chemotherapy switch in patients who do not respond to first-line chemotherapy.
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A Study To Assess Dynamic Changes In Plasma Proteome To Identify Early Detection And Treatment Response Biomarkers For HGSOC
Rochester, MN
This study aims to identify candidate High Grade Serous Cancer (HGSC) early detection and chemotherapy treatment response biomarkers. For the purpose of this study we define high grade serous cancers to include invasive cancers arising in the ovary and/or fallopian tubes (FT). Using mass spectrometry we will deeply profile and quantitate dynamic changes in the plasma proteome and N-gylcocapture sub-proteome that occur as a consequence of surgical debulking and platinum-based chemotherapy.
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S1011 Standard Or Extended Pelvic Lymphadenectomy In Treating Patients Undergoing Surgery For Invasive Bladder Cancer
Rochester, MN
RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.
PURPOSE: This randomized phase III trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.
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Engineering Gut Microbiome To Target Breast Cancer
Jacksonville, FL
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.
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Focal Laser Ablation Of Prostate Cancer Tumors
Rochester, MN
The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.
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Study Comparing Thin Dressings To Prevent Skin Inflammation In Breast Cancer Patients
Rochester, MN
We are doing this research study to compare radiation dermatitis severity in exposed skin protected by a thin film dressing versus skin that is not protected during radiation treatment. We will also be comparing two types of film; a perforated thin film dressing versus the standard thin film.
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Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial
Rochester, MN
The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial will determine whether systematically assessing patient reported outcomes for sleep disturbance, pain, anxiety, depression, and fatigue among patients with solid and liquid malignancies and using these data to increase the frequency of guideline-concordant care by: 1) reporting these data to their clinical teams, 2) providing patients with needs-matched symptom self-management education, and 3) suggesting evidence-based symptom management strategies to their care teams improves patients' quality of life, symptoms, and adherence to cancer treatment, while reducing their unplanned use of healthcare resources.
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A Study To Evaluate Radiation Therapy, Plasma Exchange, And Immunotherapy In Melanoma
Rochester, MN
The purpose of this study is to determine the kinetics of sPD-L1 removal and regeneration by plasma exchange in patients with melanoma.
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Testing Nivolumab And Ipilimumab With Short-Course Radiation In Advanced Rectal Cancer
Rochester, MN
The purpose of this trial is to investigate the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
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Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery
Eau Claire, WI
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Mankato, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus works in treating patients with breast cancer.
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Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Scottsdale/Phoenix, AZ
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy
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Development of Novel Mutation Detection Methods for Lung Cancer
Rochester, MN
The purpose of this study is to design and develop a lung cancer specific MassArray panel, LungCarta, that enables comprehensive detection of mutations in oncogenes frequently affected in lung cancers.
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Collecting Medical Information and Tissue Samples from Patients with Pancreatic Cancer or Other Pancreatic Disorders
Rochester, MN
The purpose of this study is to develop a panel of primary care controls to be used to compare the pancreatic disease patients who are recruited into the ongoing IRB protocol 354-06.
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A Study to Identify Genetic Markers in Non-Cancerous Prostate Tissues, and Compare to Better Identify the Markers Unique to Prostate Cancer
Rochester, MN
The purpose of this study is to identify DNA methylation (genetic) markers in non-cancerous prostate tissue, and compare with the markers previously found to be in prostate cancer tissue. This will provide data that can be used to identify genetic marker profiles to diagnose and provide prognosis for prostate cancer.
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Clinicopathological and Molecular Characteristics Associated With Acquired Resistance to Kinase Inhibitors in Thyroid Cancer
Rochester, MN
Objectives
The purpose of this study is to understand the clinicopathological and molecular characteristics associated with acquired resistance to kinase inhibitors in thyroid cancer.
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Vaccine Therapy and Resiquimod in Treating Patients with Stage II-IV Melanoma that has been Removed by Surgery
Rochester, MN
This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.
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Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This pilot clinical trial studies lisinopril in reducing shortness of breath caused by radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects caused by radiation therapy in patients with lung cancer.
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Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
Rochester, MN
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
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Olmsted County Healthy Skin Study
Rochester, MN
The overall goal of the Olmsted County Health Skin Study is to describe the broader community with respect to knowledge of melanoma, attitudes about tanning, perceived risk of developing melanoma, and estimated risk of developing melanoma based on participant characteristics.
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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Histology of Functional Density in Postmenopausal Breast
Rochester, MN
Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake (functional density) in the breast. In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI.
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Exploring Duodenal Biopsies As A Biomarker Of Pancreatic Cancer
Rochester, MN
To determine whether the microbiome, metagenome and metabolome of the tissue of the second portion of duodenum of patients with pancreatic cancer are different from that of patients with benign conditions not affecting the pancreas.
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Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.
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A Study To Analyze Onvansertib Treatment In Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
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Understanding The Patient Experience In Progesterone Management For Endometrial Cancer And Complex Atypical Hyperplasia
Rochester, MN
The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).
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A Study Of Staging Procedures To Diagnose Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to compare whether surgical staging is more accurate than imaging procedures when diagnosing malignant lung mesothelioma.
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Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
Rochester, MN
The purpose of this study is to assess the effectiveness of [18F]FAPI-74 in detecting FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer.
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Improving Breast Cancer Risk Prediction By Intergrating Molecular Pathology, Radiology, And Genetics
Jacksonville, FL; Rochester, MN
The purpose of this study is todetermine if combining breast cancer (BC) risk information derived from genetics, radiological images, pathology, and molecular biology we can improve risk prediction among patients with benign breast disease (BBD). Specifically, we hypothesize that breast cancer risk is determined by the number and severity of BBD lesions identified and the likelihood that new BBD lesions (i.e., breast cancer precursors) will develop.
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Interviews About Social Determinants Of Health In Southeast Asian Americans To Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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A Study Of Hypofractionated Radiotherapy To The Whole Breast Alone Before Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer.
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Safe Omission Of Pelvic Lymph Node Dissection During Radical Prostatectomy
Jacksonville, FL
This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.
Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, ...
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In-home Intravesical Chemotherapy For The Treatment Of Bladder Cancer, INVITE Trial
Jacksonville, FL
This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. ...
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Outcomes Of Low-risk Endometrial Cancer With Isolated Tumor Cells In The Sentinel Lymph Nodes: A Prospective Multicenter Single-arm Observational Study
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to prospectively evaluate the prognostic role of ITC versus negative nodes in patients with low-risk endometrial cancer who undergo SLN biopsy.
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Remote Intervention For Strength Training In Endometrial Cancer
Rochester, MN
The purpose of this study is to positively impact endometrial cancer (EC) survivorship through a fully remote home-based exercise program. We believe this type of survivorship care will be accessible, sustainable, and scalable. We seek to design and implement a telehealth strength-based exercise intervention in rural EC survivors, a group currently overlooked in most survivorship studies.
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A Study To Evaluate Androgen-Deprivation Therapy And Radiation Therapy In Treating Patients With Prostate Cancer
La Crosse, WI
The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area in patients with prostate cancer to find out which is better.
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A Comparison Of TULSA Procedure Vs. Radical Prostatectomy In Participants With Localized Prostate Cancer (CAPTAIN)
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare the safety and effectiveness for the TULSA Procedure versus radical prostatectomy in treating men with localized intermediate-risk prostate cancer.
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Gemcitabine Hydrochloride With Or Without Erlotinib Hydrochloride Followed By The Same Chemotherapy Regimen With Or Without Radiation Therapy And Capecitabine Or Fluorouracil In Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery
Jacksonville, FL; Rochester, MN
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor ...
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A Study To Evaluate The Da Vinci® Xi™ Surgical System In Nipple Sparing Mastectomy (NSM) Procedures
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.
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Pembrolizumab With Or Without Anetumab Ravtansine In Treating Patients With Mesothelin-Positive Pleural Mesothelioma
Jacksonville, FL; Rochester, MN
The purpose of this randomized phase I/II trial is to study the side effects and how well pembrolizumab with or without anetumab ravtansine work in treating patients with mesothelin-positive pleural mesothelioma. Monoclonal antibodies, such as anetumab ravtansine and pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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Atezolizumab, Pemetrexed Disodium, Cisplatin, And Surgery With Or Without Radiation Therapy In Treating Patients With Stage I-III Pleural Malignant Mesothelioma
Scottsdale/Phoenix, AZ; Rochester, MN
To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible and safe (as defined in Section 11.1) for patients with resectable malignant pleural mesothelioma.
a. To evaluate progression free survival (both by RECIST 1.1 and also using a Modified RECIST for Pleural Tumors) in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.
b. To evaluate overall survival in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.
c. ...
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Evaluation Of Neuroendocrine Differentiation As A Potential Mechanism Of Tumor Recurrence Following Radiotherapy In Prostate Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2. Correlation ...
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Pre-myeloid Cancer And Bone Marrow Failure Clinic Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test a new technology called Next Generation Sequencing (NGS) that may help identify this risk associated with precursor conditions and the likelihood that they will change into overt blood and bone marrow cancers. NGS is a procedure that looks at relevant cancer associated genes and what they do.
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A Study To Evaluate Binimetinib In Combination With Encorafenib In Patients With Pancreatic Malignancies And A Somatic BRAFV600E Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.
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A Study Of Abiraterone Acetate Plus Prednisone With Or Without Abemaciclib In Participants With Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
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A Study To Evaluate Lasofoxifene Versus Fulvestrant In Advanced Or Metastatic ER+/HER2− Breast Cancer Patients With An ESR1 Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer with an acquired ESR1 mutation and who have disease progression on an aromatase inhibitor (AI) in combination with a cyclin dependent kinase (CDK) 4/6 inhibitor. The primary objective is to evaluate the progression free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2−) breast cancer with an ESR1 mutation.
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International Multicenter Registry of Cancer of the Pancreas Screening
Jacksonville, FL
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To determine whether a surveillance program consisting of in a cohort of high-risk individuals results in an excess number of detected and surgically resected high-grade premalignant lesions and early stage pancreatic cancers compared to the natural disease development and manifestation.
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To determine whether above mentioned strategy results in an improved survival
compared to high-risk individuals not under surveillance and compared to the survival
statistics of sporadic pancreatic cancer.
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To determine patient and lesion characteristics by which precursor lesions can be stratified according ...
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A Study to Establish a Platform for Managing Pancreatic Adenocarcinoma Using Patient-derived Tumoroids
Jacksonville, FL
The purposes of this study are to determine the optimal patient-derived tumoroid (PDT) model, to determine the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach, to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish PDT as a platform for a personalized approach to guide multimodality treatment.
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Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
Rochester, MN
This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.
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A Study of Everolimus with or without Bevacizumab for Treating Patients with Advanced Kidney Cancer that Progressed after First-Line Therapy
No Locations
The purpose of this study is to compare the effectiveness of giving everolimus alone, or combined with bevacizumab for the treatment of patients who have advanced kidney cancer that has progressed after the first-line of therapy. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can interfere with tumor growth by blocking the ability of tumor cells to grow and spread. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with bevacizumab ...
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A Study to Compare Outcomes of Patients Who Underwent Open and Robotic Prostatectomy for Prostate Cancer
Rochester, MN
The objective of this study is to compare perioperative and oncologic outcomes of patients undergoing open and robotic prostatectomy for prostate cancer.
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Renal Mass Registry
Scottsdale/Phoenix, AZ
RCC is a cancer that is poorly understood. The increase in both incidence and mortality rates for RCC, coupled with the lack of effective therapies for RCC beyond surgical excision, underscore the need for a better understanding of RCC tumor biology, immunology, and epidemiology. Such improved understanding could then be directly translated into new prevention strategies as well as improved patient care. Recently, the National Cancer Institute's Kidney Cancer Progress Review Group identified as top priorities for future research the need to "better understand the mechanisms underlying known risk factors for kidney cancer" and "examine tumor tissue to identify predictors ...
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Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more cancer cells.
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A Multicenter Study In Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence For Rapid Lung Cancer Detection - The ON-SITE Study
Jacksonville, FL
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
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A Study To Evaluate The Impact Of Non-invasive Tests For Bladder Cancer
Rochester, MN
Levels of bladder cancer-derived extracellular vesicles become undetectable after radical cystectomy in patients with localized bladder cancer. This study hopes to determine the levels of bladder cancer-derived extracellular vesicles pre- and post-RC.
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Gemcitabine Hydrochloride In Treating Patients With Locally Advanced Pancreatic Cancer
Rochester, MN
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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A Study To Follow Durability Of Patient Responses From Studies UT001 And TC-BC-12
Jacksonville, FL; Rochester, MN
The purposes of this study are to determine the durability of response in patients with low grade upper tract urothelial carcinoma (LG-UTUC) treated with JELMYTO in Study UT001 who completed the study with a durable response, and the durability of response in patients with low grade non-muscle invasive bladder cancer (LG-NMIBC) treated with UGN-102 in Study TC-BC-12 who completed the study with a durable response.
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A Study To Determine Molecular Mechanisms In Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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Skin Appearance And Quality Of Life In Breast Cancer Survivors On Aromatase Inhibitor Therapy
Jacksonville, FL
This project will be a pilot study aiming to describe the change of skin quality after initiation of Aromatase Inhibitor therapy in Breast Cancer survivors through use of VISIA CA technology and skincare intervention.
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A Study Of Prostate Cancer Diagnosis Virtual Reality Assistant (ViRA) In Newly Diagnosed Black Men
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness of the PPCD ViRA on the delivery of PPCD support in a clinic setting, at home and community setting; and in providing SDOH navigation, emotional support and psycho-oncology support for BM newly diagnosed with CaP.
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A Multi-center Trial To Evaluate Multiple Regimens In Metastatic Pancreatic Cancer
Rochester, MN
The primary objectives for this study are to compare each investigational arm versus standard of care (SOC) for superiority in overall survival in 1st and/or 2nd line metastatic pancreatic cancer patients, and to determine which, if any, patients benefit from each investigational arm.
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A Study Of LOXO-783 In Patients With Breast Cancer/Other Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
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Effects Of A Hospitality Initiative On Referral Patterns For Native American Cancer Patients In Maricopa County
Scottsdale/Phoenix, AZ
The purpose of this study is to interview patients and providers at Phoenix Indian Medical Center and Mayo Clinic Arizona to identify perceptions, experiences, and perceived factors influencing referrals and enrollment on clinical trials in the Department of Radiation Oncology at Mayo Clinic Arizona.
The overall goal of this line of research is to enhance the hospitality, cultural responsiveness, and efficiency with which a leading cancer center can collaborate with a neighboring treatment hub for an important, underserved population within that cancer center’s catchment area.
American Indian and Alaska Native people experience higher rates of cancer ...
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A Study To Evaluate The Development Of Patient Derived Xenografts In Patients With Breast Cancer
Rochester, MN
Collection of tissue and blood from patients with residual disease after neoadjuvant systemic therapy for breast cancer. We hope to use these samples to find out why some patients still have cancer after they have completed neoadjuvant anticancer therapy.
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Impact Of Neoadjuvant Chemotherapy On The Peripheral Blood Immune Phenotype In Operable Breast Cancer, The ENHANCE Study
Rochester, MN
The purposes of this study are to evaluate whether pre-NAC peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.
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A Study To Learn About How Women Metabolize And Respond To Opioids When Used For Managing Post-operative Pain
Rochester, MN
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for surgical ovarian cancer patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of opioid medications.
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Long-term Follow Up Of Patients Previously Enrolled In MC1137 (BEAUTY)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to extend the follow up on the BEAUTY study (MC1137) cohort and collect additional blood samples to evaluate for minimal residual disease and tissue at the time of any breast cancer recurrence.
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Radiation Therapy With Or Without Androgen-Deprivation Therapy In Treating Patients With Prostate Cancer
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
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I-SPY 2 TRIAL: Neoadjuvant And Personalized Adaptive Novel Agents To Treat Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Ipilimumab Or High-Dose Interferon Alfa-2b In Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed By Surgery
Jacksonville, FL
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon ...
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A Study Of Niraparib Combined With Abiraterone Acetate And Prednisone Versus Abiraterone Acetate And Prednisone To Treat Metastatic Prostate Cancer
Scottsdale/Phoenix, AZ
The objectives of this study are to determine if Niraparib, Abiraterone Acetate (AA), and Prednisone compared with AA and Prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated mCSPC provides superior effectiveness in improving radiographic progression-free survival (rPFS), to assess the clinical benefit of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC, to characterize the safety profile of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC.
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Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction
Rochester, MN
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and ...
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Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative To Placebo Plus Abiraterone Plus Prednisone/Prednisolone In Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
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LEGEND Study: EG-70 In NMIBC Patients BCG-Unresponsive And High-Risk NMIBC Incompletely Treated With BCG Or BCG-Naïve
Scottsdale/Phoenix, AZ; Rochester, MN
This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC.
This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is.
The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
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Study Of REGN4018 Administered Alone Or In Combination With Cemiplimab In Adult Patients With Recurrent Ovarian Cancer Or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Rochester, MN
Primary Objectives In the Dose Escalation Phase:
- To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab.
In the Dose Expansion Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Secondary Objectives In the Dose Escalation Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR ...
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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response. The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy ...
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A Study To Evaluate Testing The Addition Of Targeted Radiation Therapy To Surgery And The Usual Chemotherapy Treatment For Stage I-IIIA Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to determine how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery ...
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Monitoring Symptoms To Help Young Women Take Hormone Therapy For Stage I-III Breast Cancer, ASPEN Study
Albert Lea, MN; Eau Claire, WI; La Crosse, WI
The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.
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A Study Comparing Proton And Photon Radiation Outcomes In Prostate Cancer Patients
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine if prostate cancer patients treated with proton therapy as compared to IMRT experience improved QOL (validated EPIC instrument measuring bowel, urinary, and sexual QOL).
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A Study To Compare Proton Therapy To Photon Radiation Therapy For Esophageal Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in ...
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A Study To Evaluate Gemcitabine And MK-3475 (Pembrolizumab) To Treat Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine ...
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Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.
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MC230302
Jacksonville, FL
This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).
Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).
Hypothesis: Patients undergoing NSM will be willing to enroll in a randomized trial ...
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A Study To Compare Two Surgical Procedures In Women With BRCA1 Mutations To Assess Reduced Risk Of Ovarian Cancer
Rochester, MN
This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
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FrαDcs Or Placebo For Patients With Advanced Stage Ovarian Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether vaccination with folate receptor alpha dendritic cells (FRalphaDCs) given to patients with advanced ovarian, fallopian tube, or primary peritoneal cancer can delay or prevent cancer recurrence, when compared with a placebo. FRalphaDCs are a vaccine made from patients' white blood cells that have been cultured in the laboratory to induce immune responses to the cancer.
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InBody Band 3 Fitness Tracker To Improve Health Outcomes And Quality Of Life In Black Prostate Cancer Survivors
Jacksonville, FL; Rochester, MN
The objective of this study is to test the acceptability and feasibility of combining a commercially available smartwatch, which tracks critical biometric data for the prediction of disease progression in individuals with cancer, with human feedback based on smartwatch activity data tailored to meet each patient’s needs.
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A Study To Evaluate The NanoKnife SYstem For Stage 3 Pancreatic Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC).
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Social Determinants Of Migrant Health Factors Impacting Prostate Cancer Care And Survivorship Among Sub-Saharan African And Caribbean Immigrant Men
Jacksonville, FL; Rochester, MN
This study is being done to understand what social factors affect health decisions for those who have immigrated from another country by examining how the immigration from Sub-Sahara Africa affects the experiences of participants regarding health-seeking behaviors, care, and treatment of prostate cancer. It also examines similarities and differences among participants based on their region of origin in Africa.
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A 3D-Printed External Breast Prosthesis For The Improvement Of Patient-reported Outcomes Among Breast Cancer Patients That Underwent A Mastectomy Without Reconstruction
Rochester, MN
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is ...
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A Consortium Trial To Evaluate Proton Vs. Photon Therapy For Patients With Non-metastatic Breast Cancer
Jacksonville, FL
The purpose of this study to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event) in patients with locally-advanced breast cancer.
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A Phase 1/2 Trial Of Gemcitabine Plus Nab-paclitaxel With Or Without FG-3019 As Neoadjuvant Chemotherapy In Locally Advanced, Unresectable Pancreatic Cancer
Jacksonville, FL
This is a Phase 1/2 trial to evaluate the safety, tolerability and efficacy of FG-3019 administered with gemcitabine and Nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
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S1602: Different Strains Of BCG With Or Without Vaccine In High Grade Non- Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.
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Low Dose Computed Tomography For Lung Cancer Screening
Rochester, MN
This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.
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Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery
Eau Claire, WI
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good ...
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Mankato, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus works in treating patients with breast cancer.
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Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Scottsdale/Phoenix, AZ
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy
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Development of Novel Mutation Detection Methods for Lung Cancer
Rochester, MN
The purpose of this study is to design and develop a lung cancer specific MassArray panel, LungCarta, that enables comprehensive detection of mutations in oncogenes frequently affected in lung cancers.
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Collecting Medical Information and Tissue Samples from Patients with Pancreatic Cancer or Other Pancreatic Disorders
Rochester, MN
The purpose of this study is to develop a panel of primary care controls to be used to compare the pancreatic disease patients who are recruited into the ongoing IRB protocol 354-06.
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A Study to Identify Genetic Markers in Non-Cancerous Prostate Tissues, and Compare to Better Identify the Markers Unique to Prostate Cancer
Rochester, MN
The purpose of this study is to identify DNA methylation (genetic) markers in non-cancerous prostate tissue, and compare with the markers previously found to be in prostate cancer tissue. This will provide data that can be used to identify genetic marker profiles to diagnose and provide prognosis for prostate cancer.
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Clinicopathological and Molecular Characteristics Associated With Acquired Resistance to Kinase Inhibitors in Thyroid Cancer
Rochester, MN
Objectives
The purpose of this study is to understand the clinicopathological and molecular characteristics associated with acquired resistance to kinase inhibitors in thyroid cancer.
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Vaccine Therapy and Resiquimod in Treating Patients with Stage II-IV Melanoma that has been Removed by Surgery
Rochester, MN
This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.
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Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer
Rochester, MN; Scottsdale/Phoenix, AZ
This pilot clinical trial studies lisinopril in reducing shortness of breath caused by radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects caused by radiation therapy in patients with lung cancer.
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Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
Rochester, MN
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
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Olmsted County Healthy Skin Study
Rochester, MN
The overall goal of the Olmsted County Health Skin Study is to describe the broader community with respect to knowledge of melanoma, attitudes about tanning, perceived risk of developing melanoma, and estimated risk of developing melanoma based on participant characteristics.
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Adrenocortical Carcinoma in Children
Rochester, MN
Adrenocortical carcinoma (ACC) is an aggressive, rare childhood cancer. Limited evidence exists on a definite histopathological criterion to differentiate ACC from adrenocortical adenomas. Early diagnosis and management is the key. Surgery is the mainstay of treatment. Even after complete resection, a high risk of recurrence of ACC remains. Despite multi-modality treatment strategies, ACC is associated with poor survival. Due to the rarity of pediatric ACC, limited evidence exists on morbidity and mortality of these patients as well as prognostic factors for survival. The aim of this study is to document morbidity and mortality of children with adrenocortical carcinoma (ACC) and ...
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Histology of Functional Density in Postmenopausal Breast
Rochester, MN
Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake (functional density) in the breast. In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI.
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Exploring Duodenal Biopsies As A Biomarker Of Pancreatic Cancer
Rochester, MN
To determine whether the microbiome, metagenome and metabolome of the tissue of the second portion of duodenum of patients with pancreatic cancer are different from that of patients with benign conditions not affecting the pancreas.
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Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.
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A Study To Analyze Onvansertib Treatment In Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
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Understanding The Patient Experience In Progesterone Management For Endometrial Cancer And Complex Atypical Hyperplasia
Rochester, MN
The purpose of this study is to gain a deeper understanding of the specific patient experience for women undergoing progesterone management for early-stage endometrial cancer and complex atypical hyperplasia due to morbid obesity (BMI ≥ 40).
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A Study Of Staging Procedures To Diagnose Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to compare whether surgical staging is more accurate than imaging procedures when diagnosing malignant lung mesothelioma.
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Phase 2 Study Of VGT-309 In Lung Cancer
Rochester, MN
The purpose of this study is to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
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Auranofin And Sirolimus In Treating Participants With Ovarian Cancer
Rochester, MN
This phase II trial studies how well auranofin and sirolimus work in treating participants with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to decrease the body?s immune response and may increase blood cell count.
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Interviews About Social Determinants Of Health In Southeast Asian Americans To Identify Liver Cancer Disparities
Rochester, MN
This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted.
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A Study Of Hypofractionated Radiotherapy To The Whole Breast Alone Before Breast Conserving Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery. The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer.
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Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers (18F-FAPI-74 GI)
Rochester, MN
The purpose of this study is to assess the effectiveness of [18F]FAPI-74 in detecting FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer.
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Improving Breast Cancer Risk Prediction By Intergrating Molecular Pathology, Radiology, And Genetics
Jacksonville, FL; Rochester, MN
The purpose of this study is todetermine if combining breast cancer (BC) risk information derived from genetics, radiological images, pathology, and molecular biology we can improve risk prediction among patients with benign breast disease (BBD). Specifically, we hypothesize that breast cancer risk is determined by the number and severity of BBD lesions identified and the likelihood that new BBD lesions (i.e., breast cancer precursors) will develop.
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Safe Omission Of Pelvic Lymph Node Dissection During Radical Prostatectomy
Jacksonville, FL
This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.
Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, ...
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Gingseng For Cancer Related Fatigue
Albert Lea, MN; Mankato, MN; Rochester, MN
Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. Unfortunately, there remain very few safe and effective interventions for patients with fatigue who are unable, or choose not to engage in, exercise; however, ginseng has shown promise in some preliminary studies. There is a pressing need to understand under what disease and/or treatment-specific circumstances that interventions, such as ginseng, are effective. The primary goal of this randomized, phase III study ...
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Monitoring Neoadjuvant Chemotherapy Of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation
Rochester, MN
The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.
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Urinebased Molecular Testing Versus Cystoscopy For Surveillance Of Nonmuscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate patient-reported preference for CxBladder Monitor compared to cystoscopy for patients on surveillance for NMIBC.
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MC240508: Genomic Surveillance Of Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to ...
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Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
Jacksonville, FL
This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in ...
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MR-Guided Cryoablation Of Prostate Bed Recurrences
Rochester, MN
The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.
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Effect Of Tumor Treating Fields (TTFields, 150 KHz) As Front-Line Treatment Of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine And Nab-paclitaxel (PANOVA-3)
Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Tumor Treating Fields (TTFields), in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic denocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Differences In Immunological Effects Of Vitamin D Replacement Among African American Prostate Cancer Patients With Localized Versus Metastatic Disease
Scottsdale/Phoenix, AZ; Jacksonville, FL
The aims of this study are to evaluate the prevalence of vitamin D insufficiency among B/AA prostate cancer patients and to determine the deficits in immunity associated with vitamin D insufficiency. Also, we will evaluate whether the peripheral blood immune cell function is different in B/AA prostate cancer patients with metastatic disease as compared with those with localized disease.
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MElanoma Research Lymph Node Prediction Implementation National_001 (MERLIN_001)
Rochester, MN
This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.
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An Extension Study MRI/US Fusion Imaging And Biopsy In Combination With Nanoparticle Directed Focal Therapy For Ablation Of Prostate Tissue
Rochester, MN
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
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S1216, Phase III ADT+TAK-700 Vs. ADT+Bicalutamide For Metastatic Prostate Cancer
Rochester, MN
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
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A Study Of Rucaparib Verses Physician's Choice Of Therapy In Patients With Metastatic Castration-resistant Prostate Cancer And Homologous Recombination Gene Deficiency
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib verses treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
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A Study Of Nivolumab In Participants With Metastatic Or Unresectable Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.
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Alpha-1 AD Carriers and Lung Cancer Risk
Rochester, MN
The purpose of this study is to collect medical and family histories, blood and/or tumor tissue samples from patients who are being tested for or who have or had lung cancer. This study will help us to develop better ways to screen people at risk for lung cancer and develop better treatments for patients diagnosed with lung cancer. This study will also help us to learn whether certain genes (inherited factors from your parents) increase the risk of developing lung cancer.
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Risk Stratified De-escalated De-intensified Treatment For High Risk Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine, with an acceptable upper bound confidence interval, disease free survival in patients who receive hypofractionated radiation for high risk prostate cancer. Exploratory objectives include chronic/late toxicity, among others. Late toxicity rates in the current study should besimilar to what is previously reported.
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A Study Of Vesicles, Prostate Cancer
Rochester, MN
The purpose of this study is to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) and circulating tumor DNA (ctDNA) across time and treatments.
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Study Of NanoKnife For Ablation Of Prostate Cancer In Low And Intermediate Risk Patients
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction
Rochester, MN
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and ...
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Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative To Placebo Plus Abiraterone Plus Prednisone/Prednisolone In Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
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A Study To Clinically Test The Use Of A Prostate Cancer Knowledge Questionnaire
Rochester, MN
The purpose of this study is to clinically test the use of a questionnaire to determine how well it detects differences in knowledge about prostate cancer among newly diagnosed individuals with the disease.
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A Study To See If Genetic Risk Estimation Of Breast Cancer Influences The Use Of Preventive Medication
Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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Veliparib And Combination Chemotherapy In Treating Patient With Locally Advanced Rectal Cancer
Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells ...
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PERT For Treatment Of Exocrine Pancreatic Insufficiency In Patients With Unresectable Pancreatic Cancer
Jacksonville, FL
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
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A Study For Germline Mutations Of Patients With Phyllodes Tumors Of The Breast
Rochester, MN
The purpose of this study is to determine the overall prevalence and types of germline genetic mutations in a contemporary multi-institutional cohort of women diagnosed with a phyllodes (connective tissue) tumor of the breast, to compare the overall rate and types of germline genetic mutations observed in a multi-institutional cohort of women with phyllodes tumors to the average population and women with breast cancer, and to compare the rate and types of germline genetic mutations identified between each of the histologic subtypes (grade) of phyllodes tumors (benign, borderline, malignant).
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A Study of Cediranib and Olaparib Combined, Compared to Either Drug Alone, or to a Standard Chemotherapy in Treating Patients who have a Return of Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
La Crosse, WI; Rochester, MN; Mankato, MN
The purpose of this study is to see how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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A Study of Alcohol Consumption History and Disease Free Survival in Stage III Colon Cancer Patients
Rochester, MN
The purpose of this study is to assess the relationship between lifetime and recent alcohol consumption history and disease free survival in a population of stage III colon cancer patients treated with chemotherapy and curative surgical resection.
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A Study to Find Markers for the Development of a Lung Cancer Screening Test
Rochester, MN
The purpose of this study is to find markers for the development of a test that will be used to define the risk of getting lung cancer in heavy smokers or to determine whether a lung nodule is cancer.
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A Study to Develop and Maintain a Registry of Specimens from Patients with Bladder Cancer
Jacksonville, FL
The purpose of this study is to develop and maintain a registry of blood and urine specimens of patients who have been treated for bladder cancer.
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Validation of Potential Biomarkers for Pancreas Cancer in Human Saliva
Jacksonville, FL
The goal of this study is to determine if the biomarkers found to be upregulated in tissue samples are specific to PDAC and can be detected in saliva. Saliva will be collected form PDAC and control subjects for comparison. Additionally, to determine if the biomarkers are specific to PDAC or other KRAS driven cancers, saliva will be collected from patients with breast and lung cancer. The saliva collected from these subjects will be studied for the presence of specific protein biomarkers and used in experiments such as western blots and ELISAs.
Pancreatic ductal adenocarcinoma (PDAC) is one ...
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Establishing a Platform for Personalized Approach to the Management of Rectal Adenocarcinoma Using Patient-Derived Tumoroids and Organoids
Jacksonville, FL
The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Treating Patients with Stage III Colon Cancer Previously Treated with Surgery
Jacksonville, FL; Rochester, MN
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving ...
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A Study of LY2090314 and Chemotherapy in Participants with Metastatic Pancreatic Cancer
Jacksonville, FL; Rochester, MN
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.
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The Road to Wellness after Breast Cancer
Rochester, MN
The purpose of this study is to determine the feasibility and the effect of a wellness coaching intervention (WCI) on quality of life, weight, and healthy lifestyle in overweight breast cancer survivors.
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A Study to Evaluate the Epidemiology of Estrogen Genotoxicity in Breast Cancer
Rochester, MN
The purpose of this study is to recruit 2000 incident cases of primary breast cancer in order to perform laboratory assays to measure frequencies of genetic polymorphisms for genes that encode enzymes involved in candidate gene pathways, including: estrogen and catecholestrogen formation, bioactivation and inactivation, cellular proliferation and apoptosis, nuclear factor kappa-beta; to compare genotype frequencies for polymorphisms of genes in breast cancer cases and controls, and to evaluate possible interactions among common polymorphisms in candidate genes.
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A Study Of JNJ-69086420, An Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (HK2) For Advanced Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).
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A Study to Continue A Long Term Follow-Up of Patients Given Doxorubicin-Cyclophosphamide Therapy for Breast Cancer
La Crosse, WI
The purpose of this study is to continue with a long term follow-up of previously enrolled people treated with doxorubicin-cyclophosphamid followed by paclitaxel or docetaxel for axillary node-positive or high risk node-negative breast cancer.
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination ...
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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised ...
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MiCaP Research Digest
Jacksonville, FL
The purpose of this study is to test if the MiCaP Research Digest videos meet the needs of black men in learning more about prostate cancer scientific discoveries. We are asking for feedback on the videos to determine if they are easy to understand, credible, informative, and valuable. The goal is to create educational programming that helps black men make informed decisions about their prostate healthcare since they are diagnosed with prostate cancer more than any other race or ethnicity.
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Equity Of Cancer Screening And Follow-up For Lung Cancer
Rochester, MN
The purpose of this study is to elucidate factors that contribute to lung cancer disparities between rural and urban areas and provide contextual information for future interventions and policies. Our specific aims are to: (1) Characterize the delivery of evidence-based interventions (EBIs) for lung cancer prevention and early detection, comparing rural to urban areas, by assessing differences in use of smoking cessation interventions and lung cancer screening (LCS) at multiple levels of influences; (2) Identify potentially modifiable care gaps across the LCS continuum, including risk assessment and timely treatment, by examining patients who died of lung cancer relative to patients ...
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Atezolizumab In Combination With A Multi-Kinase Inhibitor For The Treatment Of Unresectable, Locally Advanced, Or Metastatic Liver Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to test whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...
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A Study To Reduce Disparities In High-Risk Black Men (BM) With Advanced Prostate Cancer Using Patient-Centered Home Care
Jacksonville, FL
The purpose of this study is to evaluate a highly innovative project evaluating the feasibility of patient-centered home care (PCHC) as a new model of cancer care to reduce disparities and improve health related qualtiy of life (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP).
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A Study To Evaluate Regional Radiotherapy In Biomarker Low-Risk Node Positive Breast Cancer
Jacksonville, FL
The purpose of this study is to compare the effects on low-risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
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Study Of Targeted Therapy Vs. Chemotherapy In Patients With Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.
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Vascular Function In Breast Cancer Survivors
Jacksonville, FL
The goal of this pilot study is to demonstrate that obesity is associated with worse reactive hyperemic index, a marker of vascular function, in breast cancer survivors. For this, we propose to measure and compare reactive hyperemic index in breast cancer survivors with and without obesity.
Background
Cardiovascular disease (CVD) is the leading cause of death in women, accounting for 35% of female deaths. While in the past five decades, the 5-year breast cancer (BC)-specific mortality decreased from 25% to 9%, BC survivors are dying of CVD at unprecedented rates. Compared to women who have never ...
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BCG In Combination With Durvalumab In Adult BCG-naïve, High-risk NMIBC Participants (PATAPSCO)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of durvalumab (1500 mg iv for 13 cycles every four weeks (q4w) + BCG (induction and maintenance) combination therapy by assessment of Grade 3/4 PRAEs in high-risk NMIBC participants.
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A Study Of Adjuvant Cretostimogene Grenadenorepvec For Treatment Of Intermediate Risk NMIBC Following TURBT
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
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CATALINA-2: A Clinical Study Of TORL-1-23 In Platinum-resistant Ovarian Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
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AI-Augmented Imaging For Early Detection Of Pancreatic Cancer Acronym: AI-PACED
Rochester, MN
To evaluate the feasibility and potential clinical utility of serial AI-augmented computed tomography (CT) imaging and longitudinal blood biobanking in individuals with glycemically-defined new-onset diabetes (gNOD) and elevated pancreatic cancer risk (ENDPAC score ≥3), with the aim of determining whether this approach enables earlier detection of pancreatic ductal adenocarcinoma (PDA) relative to symptom-driven diagnosis
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A Study To Evaluate The Efficacy Of A Hybrid Imaging And Measurement Tool For Breast Cancer Detection And Monitoring
Rochester, MN
The purpose of this research is to optimize and evaluate the efficacy of a hybrid imaging and quantitative viscoelasticity measurement tool for breast cancer detection and monitoring.
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Infrared Spectroscopy To Analyze Volatile Organic Compounds In The Breath Of Patients With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
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Pivotal Study Of The NanoKnife System For The Ablation Of Prostate Tissue
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Study Of Adjuvant Cemiplimab Versus Placebo After Surgery And Radiation Therapy In Patients With High Risk Cutaneous Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study is to compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT -To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT; to compare the effect of adjuvant cemiplimab with that of placebo on patients' ...
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A Study Of Intravesical Enfortumab Vedotin For Treatment Of Patients With Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to test drug enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
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Two Studies For Patients With High Risk Prostate Cancer Testing Less Intense Treatment For Patients With A Low Gene Risk Score And Testing A More Intense Treatment For Patients With A High Gene Risk Score
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Rochester, MN
The puporse of this trial is to compare less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses ...
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Comparison Of Acute Toxicities Between Patients Treated With Protons Or Intensity Modulated Radiation Therapy After Surgery For The Treatment Of Endometrial Or Cervical Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).
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3D Ultrasound Imaging For Breast Cancer Diagnosis
Rochester, MN
The purpose of this study is to evaluate the effectiveess of a new 3D ultrasound imaging technology combining B-mode, microvessel imaging, shear wave elastography, and machine learning for breast lesion diagnosis.
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A Study To Test Adding Pembrolizumab To Olaparib Alone As Therapy For Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary purpose of this study is to evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
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A Study To Analyze The Safety And Effectiveness Of The NanoKnife® System In Unresectable Stage 3 Pancreatic Adenocarcinom Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System for the ablation of unresectable Stage 3 pancreatic adenocarcinoma (Stage 3 pancreatic cancer).
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A Clinical Study To Investigate The Efficacy And Safety Of An Investigational Combination Therapy With BNT324 And BNT327 In Patients With Advanced Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
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A Study of Treatment with Docetaxel and Prednisone, with or without Vaccine Therapy, for Patients who have Metastatic Hormone-Resistant Prostate Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of treatment with docetaxel and prednisone, with or without vaccine therapy for patients who have hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from an antigen may help the body build an effective immune response to kill tumor cells. It is not yet known whether docetaxel and prednisone are more effective with ...
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery
Eau Claire, WI
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
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Analyzing Oesophago-Gastric Leaks From Diagnosis to Management
Jacksonville, FL
THe purpose of this international study is to identify the incidence of oesophago-gastric leaks, identify when they are diagnosed and how they are specifically managed.
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Evaluation of Sensibility with Targeted Nipple Areola Complex Re-innervation in Nipple Sparing Mastectomy
Scottsdale/Phoenix, AZ
To determine the effectiveness of targeted nipple areola complex (NAC) re-innervation for improving sensibility in women undergoing nipple sparing mastectomy (NSM).
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A Study To Follow Durability Of Patient Responses From Studies UT001 And TC-BC-12
Jacksonville, FL; Rochester, MN
The purposes of this study are to determine the durability of response in patients with low grade upper tract urothelial carcinoma (LG-UTUC) treated with JELMYTO in Study UT001 who completed the study with a durable response, and the durability of response in patients with low grade non-muscle invasive bladder cancer (LG-NMIBC) treated with UGN-102 in Study TC-BC-12 who completed the study with a durable response.
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A Study To Determine Molecular Mechanisms In Breast Implant Associated-Anaplastic Large Cell Lymphoma
Jacksonville, FL
The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) tumor specimens and healthy control tissue.
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Skin Appearance And Quality Of Life In Breast Cancer Survivors On Aromatase Inhibitor Therapy
Jacksonville, FL
This project will be a pilot study aiming to describe the change of skin quality after initiation of Aromatase Inhibitor therapy in Breast Cancer survivors through use of VISIA CA technology and skincare intervention.
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A Multicenter Study In Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence For Rapid Lung Cancer Detection - The ON-SITE Study
Jacksonville, FL
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
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A Study Of Prostate Cancer Diagnosis Virtual Reality Assistant (ViRA) In Newly Diagnosed Black Men
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness of the PPCD ViRA on the delivery of PPCD support in a clinic setting, at home and community setting; and in providing SDOH navigation, emotional support and psycho-oncology support for BM newly diagnosed with CaP.
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A Study Of Niraparib Combined With Abiraterone Acetate And Prednisone Versus Abiraterone Acetate And Prednisone To Treat Metastatic Prostate Cancer
Scottsdale/Phoenix, AZ
The objectives of this study are to determine if Niraparib, Abiraterone Acetate (AA), and Prednisone compared with AA and Prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated mCSPC provides superior effectiveness in improving radiographic progression-free survival (rPFS), to assess the clinical benefit of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC, to characterize the safety profile of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC.
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Monitoring Symptoms To Help Young Women Take Hormone Therapy For Stage I-III Breast Cancer, ASPEN Study
Albert Lea, MN; Eau Claire, WI; La Crosse, WI
The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.
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A Study Comparing Proton And Photon Radiation Outcomes In Prostate Cancer Patients
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine if prostate cancer patients treated with proton therapy as compared to IMRT experience improved QOL (validated EPIC instrument measuring bowel, urinary, and sexual QOL).
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A Study To Compare Proton Therapy To Photon Radiation Therapy For Esophageal Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in ...
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A Study To Evaluate Gemcitabine And MK-3475 (Pembrolizumab) To Treat Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine ...
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Effects Of A Hospitality Initiative On Referral Patterns For Native American Cancer Patients In Maricopa County
Scottsdale/Phoenix, AZ
The purpose of this study is to interview patients and providers at Phoenix Indian Medical Center and Mayo Clinic Arizona to identify perceptions, experiences, and perceived factors influencing referrals and enrollment on clinical trials in the Department of Radiation Oncology at Mayo Clinic Arizona.
The overall goal of this line of research is to enhance the hospitality, cultural responsiveness, and efficiency with which a leading cancer center can collaborate with a neighboring treatment hub for an important, underserved population within that cancer center’s catchment area.
American Indian and Alaska Native people experience higher rates of cancer ...
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A Study To Evaluate The Development Of Patient Derived Xenografts In Patients With Breast Cancer
Rochester, MN
Collection of tissue and blood from patients with residual disease after neoadjuvant systemic therapy for breast cancer. We hope to use these samples to find out why some patients still have cancer after they have completed neoadjuvant anticancer therapy.
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Impact Of Neoadjuvant Chemotherapy On The Peripheral Blood Immune Phenotype In Operable Breast Cancer, The ENHANCE Study
Rochester, MN
The purposes of this study are to evaluate whether pre-NAC peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.
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A Study To Learn About How Women Metabolize And Respond To Opioids When Used For Managing Post-operative Pain
Rochester, MN
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for surgical ovarian cancer patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of opioid medications.
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Long-term Follow Up Of Patients Previously Enrolled In MC1137 (BEAUTY)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to extend the follow up on the BEAUTY study (MC1137) cohort and collect additional blood samples to evaluate for minimal residual disease and tissue at the time of any breast cancer recurrence.
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A Multi-center Trial To Evaluate Multiple Regimens In Metastatic Pancreatic Cancer
Rochester, MN
The primary objectives for this study are to compare each investigational arm versus standard of care (SOC) for superiority in overall survival in 1st and/or 2nd line metastatic pancreatic cancer patients, and to determine which, if any, patients benefit from each investigational arm.
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A Study Of LOXO-783 In Patients With Breast Cancer/Other Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
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LEGEND Study: EG-70 In NMIBC Patients BCG-Unresponsive And High-Risk NMIBC Incompletely Treated With BCG Or BCG-Naïve
Scottsdale/Phoenix, AZ; Rochester, MN
This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC.
This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is.
The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
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Study Of REGN4018 Administered Alone Or In Combination With Cemiplimab In Adult Patients With Recurrent Ovarian Cancer Or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Rochester, MN
Primary Objectives In the Dose Escalation Phase:
- To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimab.
In the Dose Expansion Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Secondary Objectives In the Dose Escalation Phase:
- To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with cemiplimab (separately by cohort) as determined by ORR ...
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Primary Breast Oligoprogressive Metastatic Disease Treated With Stereotactic Body Radiation Therapy To Obviate The Need To Change Systemic Therapy (BOSS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response, to assess the role of circulating tumor DNA (ctDNA) in stratifying outcomes (and corresponding treatment paradigms) for patients with oligoprogressive breast cancer, and to assess whether metastasis-directed radiotherapy can delay a change in systemic therapy, thereby preventing the transition to more toxic treatment regimens with lower rates of response. The future aim of this work is to develop a large, cooperative group trial testing the role of local therapy ...
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A Study To Evaluate Testing The Addition Of Targeted Radiation Therapy To Surgery And The Usual Chemotherapy Treatment For Stage I-IIIA Malignant Pleural Mesothelioma
Rochester, MN
The purpose of this study is to determine how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery ...
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Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of BTX-9341 In Advanced And/or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.
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Risk Stratified De-escalated De-intensified Treatment For High Risk Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine, with an acceptable upper bound confidence interval, disease free survival in patients who receive hypofractionated radiation for high risk prostate cancer. Exploratory objectives include chronic/late toxicity, among others. Late toxicity rates in the current study should besimilar to what is previously reported.
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A Study Of Vesicles, Prostate Cancer
Rochester, MN
The purpose of this study is to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) and circulating tumor DNA (ctDNA) across time and treatments.
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Study Of NanoKnife For Ablation Of Prostate Cancer In Low And Intermediate Risk Patients
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Radiation Therapy With Or Without Androgen-Deprivation Therapy In Treating Patients With Prostate Cancer
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
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I-SPY 2 TRIAL: Neoadjuvant And Personalized Adaptive Novel Agents To Treat Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
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Ipilimumab Or High-Dose Interferon Alfa-2b In Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed By Surgery
Jacksonville, FL
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon ...
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Botulinum Toxin A (Botox) In Tissue Expander Breast Reconstruction
Rochester, MN
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and ...
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Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative To Placebo Plus Abiraterone Plus Prednisone/Prednisolone In Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
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A Study To Clinically Test The Use Of A Prostate Cancer Knowledge Questionnaire
Rochester, MN
The purpose of this study is to clinically test the use of a questionnaire to determine how well it detects differences in knowledge about prostate cancer among newly diagnosed individuals with the disease.
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A Study To See If Genetic Risk Estimation Of Breast Cancer Influences The Use Of Preventive Medication
Rochester, MN
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
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Veliparib And Combination Chemotherapy In Treating Patient With Locally Advanced Rectal Cancer
Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells ...
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PERT For Treatment Of Exocrine Pancreatic Insufficiency In Patients With Unresectable Pancreatic Cancer
Jacksonville, FL
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
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A Study For Germline Mutations Of Patients With Phyllodes Tumors Of The Breast
Rochester, MN
The purpose of this study is to determine the overall prevalence and types of germline genetic mutations in a contemporary multi-institutional cohort of women diagnosed with a phyllodes (connective tissue) tumor of the breast, to compare the overall rate and types of germline genetic mutations observed in a multi-institutional cohort of women with phyllodes tumors to the average population and women with breast cancer, and to compare the rate and types of germline genetic mutations identified between each of the histologic subtypes (grade) of phyllodes tumors (benign, borderline, malignant).
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Cancer Prevention: Stories For Change In Hispanic Community
Rochester, MN
This study is a process evaluation of a digital storytelling (DST) intervention. Because the DST intervention has not yet been developed, it is appropriate to use qualitative methods to assess the process.
This study will recruit gifted storytellers for a digital storytelling intervention on breast, cervical, and colorectal cancer. A digital storytelling intervention will be developed to improve breast, cervical, and colorectal cancer screening rates among Hispanic, Spanish speaking individuals. Additionally, to conduct a qualitative assessment of the digital storytelling workshop.
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A Study To Evaluate Ribociclib Plus Letrozole To Treat Cancer Of The Ovary, Fallopian Tube Or Peritoneum
Rochester, MN
The purpose of this study is to evaluate the response to treatment with Ribociclib and Letrozole in patients with low-grade serous cancer of the ovary, fallopian tube or peritoneum.
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A Study Of BBI503 In Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Rochester, MN
This is an open label, single-arm, phase II study. The study population is adult patients with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.
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A Phase 1 In Patients With HLA-A*0201+ And WT1+ Recurrent/Metastatic Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of Part A of this study is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.
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Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Rochester, MN
There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women ...
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A Study Combining Tofacitinib with Gemcitabine for the Treatment of Pancreas Cancer in Patients who are Losing Weight
Rochester, MN
The purpose of this study is to test the safety, tolerability and possible benefit of a drug called tofacitinib in patients with metastatic pancreas cancer when given combined with a standard chemotherapy drug called gemcitabine.
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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Scottsdale/Phoenix, AZ
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020.
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A Study of Paclitaxel with or without Cixutumumab as Second-Line Therapy for Treating Patients with Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well paclitaxel, with or without cixutumumab, works for treating patients who have esophageal cancer or gastroesophageal junction cancer that has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cixutumumab may kill cancer cells by blocking the action of a protein needed for cancer cell growth. Giving paclitaxel with or without cixutumumab may kill more tumor cells.
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A Study of the Use of Molecular Breast Imaging to Evaluate Breast Cancer Tumor Response to Therapy that is Newly Supplemental to Standard Treatment
Rochester, MN
The purpose of this study is to evaluate the use of molecular breast imaging as an accurate way to assess the response of breast cancer tumors to chemotherapy or hormone therapy that is newly supplemental to the standard treatment.
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Breast-Conserving Surgery and Radiation Therapy in Patients with Multiple Ipsilateral Breast Cancer
Rochester, MN
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer
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A Study of Clinical Outcomes Associated with Lenvatinib Treatment in Patients with Anaplastic Thyroid Cancer
Rochester, MN
The purpose of this study is to assess the use of lenvatinib to treat anaplastic thyroid cancer.
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Breast Cancer: Can We Predict Pathological Complete Response Following Neoadjuvant Treatment?
Scottsdale/Phoenix, AZ
This project will investigate whether ctDNA analysis in newly diagnosed stage I, II, III breast cancer patients treated with neoadjuvant systemic therapy can predict pathological Complete Response (pCR).
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A Study To Increase Understanding About Pancreatic Cancer Genetics And Response To Drug Therapy
Rochester, MN
The purpose of this study is to learn more about pancreatic cancer genetics in association with response to drug therapy. Pancreatic cancer has identifiable genetic (DNA) changes, yet for many it is not known whether these affect response to cancer drugs.
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A Study Of Pancreatic Cancer Voice Signature (PanVoS)
Jacksonville, FL
The purpose of this study is to identify and describe disease‑related voice changes.
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3D Ultrasound For The Imaging Of Axillary Lymph Nodes In Patients With Breast Cancer
Rochester, MN
The overall goal of this project is to study a new 3D ultrasound imaging technology for evaluation of axillary lymph nodes in patients with breast cancer.
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Veliparib And Topotecan Hydrochloride In Treating Patients With Solid Tumors, Relapsed Or Refractory Ovarian Cancer, Or Primary Peritoneal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose of the combination of ABT-888 and weekly topotecan in adult patients with advanced solid tumors, and to identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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A Study of Cediranib and Olaparib Combined, Compared to Either Drug Alone, or to a Standard Chemotherapy in Treating Patients who have a Return of Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
La Crosse, WI; Rochester, MN; Mankato, MN
The purpose of this study is to see how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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A Study of Alcohol Consumption History and Disease Free Survival in Stage III Colon Cancer Patients
Rochester, MN
The purpose of this study is to assess the relationship between lifetime and recent alcohol consumption history and disease free survival in a population of stage III colon cancer patients treated with chemotherapy and curative surgical resection.
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A Study to Find Markers for the Development of a Lung Cancer Screening Test
Rochester, MN
The purpose of this study is to find markers for the development of a test that will be used to define the risk of getting lung cancer in heavy smokers or to determine whether a lung nodule is cancer.
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A Study to Develop and Maintain a Registry of Specimens from Patients with Bladder Cancer
Jacksonville, FL
The purpose of this study is to develop and maintain a registry of blood and urine specimens of patients who have been treated for bladder cancer.
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Validation of Potential Biomarkers for Pancreas Cancer in Human Saliva
Jacksonville, FL
The goal of this study is to determine if the biomarkers found to be upregulated in tissue samples are specific to PDAC and can be detected in saliva. Saliva will be collected form PDAC and control subjects for comparison. Additionally, to determine if the biomarkers are specific to PDAC or other KRAS driven cancers, saliva will be collected from patients with breast and lung cancer. The saliva collected from these subjects will be studied for the presence of specific protein biomarkers and used in experiments such as western blots and ELISAs.
Pancreatic ductal adenocarcinoma (PDAC) is one ...
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Establishing a Platform for Personalized Approach to the Management of Rectal Adenocarcinoma Using Patient-Derived Tumoroids and Organoids
Jacksonville, FL
The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil with or without Celecoxib in Treating Patients with Stage III Colon Cancer Previously Treated with Surgery
Jacksonville, FL; Rochester, MN
PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving ...
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A Study of LY2090314 and Chemotherapy in Participants with Metastatic Pancreatic Cancer
Jacksonville, FL; Rochester, MN
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.
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The Road to Wellness after Breast Cancer
Rochester, MN
The purpose of this study is to determine the feasibility and the effect of a wellness coaching intervention (WCI) on quality of life, weight, and healthy lifestyle in overweight breast cancer survivors.
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A Study to Evaluate the Epidemiology of Estrogen Genotoxicity in Breast Cancer
Rochester, MN
The purpose of this study is to recruit 2000 incident cases of primary breast cancer in order to perform laboratory assays to measure frequencies of genetic polymorphisms for genes that encode enzymes involved in candidate gene pathways, including: estrogen and catecholestrogen formation, bioactivation and inactivation, cellular proliferation and apoptosis, nuclear factor kappa-beta; to compare genotype frequencies for polymorphisms of genes in breast cancer cases and controls, and to evaluate possible interactions among common polymorphisms in candidate genes.
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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised ...
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MiCaP Research Digest
Jacksonville, FL
The purpose of this study is to test if the MiCaP Research Digest videos meet the needs of black men in learning more about prostate cancer scientific discoveries. We are asking for feedback on the videos to determine if they are easy to understand, credible, informative, and valuable. The goal is to create educational programming that helps black men make informed decisions about their prostate healthcare since they are diagnosed with prostate cancer more than any other race or ethnicity.
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A Study Of JNJ-69086420, An Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (HK2) For Advanced Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).
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A Study to Continue A Long Term Follow-Up of Patients Given Doxorubicin-Cyclophosphamide Therapy for Breast Cancer
La Crosse, WI
The purpose of this study is to continue with a long term follow-up of previously enrolled people treated with doxorubicin-cyclophosphamid followed by paclitaxel or docetaxel for axillary node-positive or high risk node-negative breast cancer.
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination ...
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Equity Of Cancer Screening And Follow-up For Lung Cancer
Rochester, MN
The purpose of this study is to elucidate factors that contribute to lung cancer disparities between rural and urban areas and provide contextual information for future interventions and policies. Our specific aims are to: (1) Characterize the delivery of evidence-based interventions (EBIs) for lung cancer prevention and early detection, comparing rural to urban areas, by assessing differences in use of smoking cessation interventions and lung cancer screening (LCS) at multiple levels of influences; (2) Identify potentially modifiable care gaps across the LCS continuum, including risk assessment and timely treatment, by examining patients who died of lung cancer relative to patients ...
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Atezolizumab In Combination With A Multi-Kinase Inhibitor For The Treatment Of Unresectable, Locally Advanced, Or Metastatic Liver Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to test whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...
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A Study To Reduce Disparities In High-Risk Black Men (BM) With Advanced Prostate Cancer Using Patient-Centered Home Care
Jacksonville, FL
The purpose of this study is to evaluate a highly innovative project evaluating the feasibility of patient-centered home care (PCHC) as a new model of cancer care to reduce disparities and improve health related qualtiy of life (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP).
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A Study To Evaluate Regional Radiotherapy In Biomarker Low-Risk Node Positive Breast Cancer
Jacksonville, FL
The purpose of this study is to compare the effects on low-risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
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Study Of Targeted Therapy Vs. Chemotherapy In Patients With Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenib/trametinib or cabozantinib.
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Vascular Function In Breast Cancer Survivors
Jacksonville, FL
The goal of this pilot study is to demonstrate that obesity is associated with worse reactive hyperemic index, a marker of vascular function, in breast cancer survivors. For this, we propose to measure and compare reactive hyperemic index in breast cancer survivors with and without obesity.
Background
Cardiovascular disease (CVD) is the leading cause of death in women, accounting for 35% of female deaths. While in the past five decades, the 5-year breast cancer (BC)-specific mortality decreased from 25% to 9%, BC survivors are dying of CVD at unprecedented rates. Compared to women who have never ...
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BCG In Combination With Durvalumab In Adult BCG-naïve, High-risk NMIBC Participants (PATAPSCO)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of durvalumab (1500 mg iv for 13 cycles every four weeks (q4w) + BCG (induction and maintenance) combination therapy by assessment of Grade 3/4 PRAEs in high-risk NMIBC participants.
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A Study Of Adjuvant Cretostimogene Grenadenorepvec For Treatment Of Intermediate Risk NMIBC Following TURBT
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
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CATALINA-2: A Clinical Study Of TORL-1-23 In Platinum-resistant Ovarian Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
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AI-Augmented Imaging For Early Detection Of Pancreatic Cancer Acronym: AI-PACED
Rochester, MN
To evaluate the feasibility and potential clinical utility of serial AI-augmented computed tomography (CT) imaging and longitudinal blood biobanking in individuals with glycemically-defined new-onset diabetes (gNOD) and elevated pancreatic cancer risk (ENDPAC score ≥3), with the aim of determining whether this approach enables earlier detection of pancreatic ductal adenocarcinoma (PDA) relative to symptom-driven diagnosis
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A Study To Evaluate The Efficacy Of A Hybrid Imaging And Measurement Tool For Breast Cancer Detection And Monitoring
Rochester, MN
The purpose of this research is to optimize and evaluate the efficacy of a hybrid imaging and quantitative viscoelasticity measurement tool for breast cancer detection and monitoring.
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Infrared Spectroscopy To Analyze Volatile Organic Compounds In The Breath Of Patients With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to use exhaled alveolar breath and the subsequent spectral data produced by Breathe BioMedical’s cavity ring-down spectrometer, the goal is to further develop Breathe BioMedical’s technology and machine learning algorithms to determine the feasibility of detecting breast cancer in women with dense breast tissue.
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Pivotal Study Of The NanoKnife System For The Ablation Of Prostate Tissue
Rochester, MN
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
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Study Of Adjuvant Cemiplimab Versus Placebo After Surgery And Radiation Therapy In Patients With High Risk Cutaneous Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study is to compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT -To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT; to compare the effect of adjuvant cemiplimab with that of placebo on patients' ...
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A Study Of Intravesical Enfortumab Vedotin For Treatment Of Patients With Non-muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to test drug enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
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Two Studies For Patients With High Risk Prostate Cancer Testing Less Intense Treatment For Patients With A Low Gene Risk Score And Testing A More Intense Treatment For Patients With A High Gene Risk Score
Albert Lea, MN; Jacksonville, FL; La Crosse, WI; Rochester, MN
The puporse of this trial is to compare less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses ...
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Comparison Of Acute Toxicities Between Patients Treated With Protons Or Intensity Modulated Radiation Therapy After Surgery For The Treatment Of Endometrial Or Cervical Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether proton radiation therapy (proton RT) reduces acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy (IMRT).
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3D Ultrasound Imaging For Breast Cancer Diagnosis
Rochester, MN
The purpose of this study is to evaluate the effectiveess of a new 3D ultrasound imaging technology combining B-mode, microvessel imaging, shear wave elastography, and machine learning for breast lesion diagnosis.
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A Study To Test Adding Pembrolizumab To Olaparib Alone As Therapy For Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations
Eau Claire, WI; La Crosse, WI; Rochester, MN
The primary purpose of this study is to evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.
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A Study To Analyze The Safety And Effectiveness Of The NanoKnife® System In Unresectable Stage 3 Pancreatic Adenocarcinom Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the NanoKnife System for the ablation of unresectable Stage 3 pancreatic adenocarcinoma (Stage 3 pancreatic cancer).
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A Clinical Study To Investigate The Efficacy And Safety Of An Investigational Combination Therapy With BNT324 And BNT327 In Patients With Advanced Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
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Cancer Prevention: Stories For Change In Hispanic Community
Rochester, MN
This study is a process evaluation of a digital storytelling (DST) intervention. Because the DST intervention has not yet been developed, it is appropriate to use qualitative methods to assess the process.
This study will recruit gifted storytellers for a digital storytelling intervention on breast, cervical, and colorectal cancer. A digital storytelling intervention will be developed to improve breast, cervical, and colorectal cancer screening rates among Hispanic, Spanish speaking individuals. Additionally, to conduct a qualitative assessment of the digital storytelling workshop.
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A Study To Predict Response To Virotherapy And Immunotherapy By Using An Ex-Vivo Three-Dimensional Patient-Derived Organoid Model Of Pediatric Urological Cancers
Rochester, MN
The purpose of this study is threefold: the first aim is to use patient-derived fresh tumor tissue to create cell lines and 3D tumor models (i.e. organoids) that preserve the characteristics of the original tumor. The preservation of the original tumor's drug resistance/response profile will be a major focus of this aim. The second aim is to conduct high-throughput testing of various drugs (e.g., virotherapy, immunotherapy) on these cell lines and 3D tumor models. The completion of the second aim is an important step towards developing a platform that can help guide treatment decisions for future patients, based on the drug ...
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Pembrolizumab In Treating Participants With Recurrent Ovarian Cancer
Rochester, MN
The purpose of this study is to evaluate how well pembrolizumab works in treating participants with ovarian cancer that has come back after previous treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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A Study To Evaluate Ribociclib Plus Letrozole To Treat Cancer Of The Ovary, Fallopian Tube Or Peritoneum
Rochester, MN
The purpose of this study is to evaluate the response to treatment with Ribociclib and Letrozole in patients with low-grade serous cancer of the ovary, fallopian tube or peritoneum.
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A Study Of BBI503 In Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Rochester, MN
This is an open label, single-arm, phase II study. The study population is adult patients with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.
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A Phase 1 In Patients With HLA-A*0201+ And WT1+ Recurrent/Metastatic Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of Part A of this study is to characterize the safety, tolerability, and biological effects of CUE-102. The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A, and to evaluate antitumor activity at this dose.
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A Study To Evaluate Durvalumab Plus Topotecan Or Lurbinectedin In Patients With Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate whether the combination of durvalumab plus lurbinectedin can increase 6 month progression-free survival, in patients with extensive stage small cell lung cancer who have progressed after treatment with an initial combination of chemotherapy and immunotherapy.
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Rifaximin For The Treatment Of Gastrointestinal Toxicities Related To Pertuzumab-Based Therapy In Patients With Stage I-III HER2 Positive Breast Cancer
Jacksonville, FL
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.
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A Study To Evaluate Immune-related Biomarkers For Pathological Response In Stage II-III HER2-positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate invasive disease-free survival (iDFS) of multi-epitope HER2 vaccine vs. placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2+ breast cancer with residual disease post-neoadjuvant chemotherapy, and to evaluate the safety of multi-epitope HER2 vaccine given concurrently with T-DM1 maintenance therapy.
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A Study Of Tucatinib Plus Trastuzumab Deruxtecan In HER2+ Breast Cancer
Rochester, MN
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
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Chemoradiation With Or Without Atezolizumab In Treating Patients With Limited Stage Small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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Study Of Endocrine Therapy With Or Without Abemaciclib (LY2835219) Following Surgery In Participants With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
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Remote Monitoring For Lifestyle Changes In Patients With Lung Cancer Related Fatigue
Rochester, MN
The purpose of this study is to test the effectiveness of a remote monitoring program with health coaching for patients with cancer related fatigue.
The primary objective is to assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory and the Cancer Fatigue Scale/ MFSI-SF. Secondary objective is to assess the effect of the program on quality of life by administering the LASA questionnaire.
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A Study Of Personalized Molecular Markers To Transform Treatment Of High Grade Endometrial Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize a landscape of DNA alterations, RNA transcripts, and microbiome changes in resected tumors and body fluids of patients that have been diagnosed with aggressive endometrial cancer (Grade 3 and Type II) in order to identify molecular targets for which therapeutic drugs may exist.
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A Study To Evaluate Durvalumab Plus Topotecan Or Lurbinectedin In Patients With Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate whether the combination of durvalumab plus lurbinectedin can increase 6 month progression-free survival, in patients with extensive stage small cell lung cancer who have progressed after treatment with an initial combination of chemotherapy and immunotherapy.
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Rifaximin For The Treatment Of Gastrointestinal Toxicities Related To Pertuzumab-Based Therapy In Patients With Stage I-III HER2 Positive Breast Cancer
Jacksonville, FL
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.
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A Study To Evaluate Immune-related Biomarkers For Pathological Response In Stage II-III HER2-positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate invasive disease-free survival (iDFS) of multi-epitope HER2 vaccine vs. placebo in combination with ado-trastuzumab emtansine (TTT-DM1) in patients with stage II-III HER2+ breast cancer with residual disease post-neoadjuvant chemotherapy, and to evaluate the safety of multi-epitope HER2 vaccine given concurrently with T-DM1 maintenance therapy.
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Testing The Role Of FDG-PET/CT To Predict Response To Therapy Prior To Surgery For HER2-positive Breast Cancer, The DIRECT Trial
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to test how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer.
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STOP-HER2: Stopping Trastuzumab In HER2+ MBC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment.
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A Study To Compare Radiation Therapy + Immune Therapy Treatment (Atezolizumab) For Extensive Stage Small Cell Lung Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...
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A Study Of Tucatinib Plus Trastuzumab Deruxtecan In HER2+ Breast Cancer
Rochester, MN
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.
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Chemoradiation With Or Without Atezolizumab In Treating Patients With Limited Stage Small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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Study Of Endocrine Therapy With Or Without Abemaciclib (LY2835219) Following Surgery In Participants With Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
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Nivolumab After Combined Modality Therapy In Treating Patients With High Risk Stage II-IIIB Anal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
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Remote Monitoring For Lifestyle Changes In Patients With Lung Cancer Related Fatigue
Rochester, MN
The purpose of this study is to test the effectiveness of a remote monitoring program with health coaching for patients with cancer related fatigue.
The primary objective is to assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory and the Cancer Fatigue Scale/ MFSI-SF. Secondary objective is to assess the effect of the program on quality of life by administering the LASA questionnaire.
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University Of California Minority Patient-Derived Xenograft (PDX) Development And Trial Center (UCaMP) To Reduce Cancer Health Disparities
Jacksonville, FL
The purpose of this study is to establish at least 200 patient-derived cancer xenografts (PDXs), and to utilize these PDXs in preclinical testing of single agents and drug combinations to guide precision cancer medicine decision-making with a focus upon the predominant racial/ethnic minority populations residing in California.
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SUPRAME-ACTengine® IMA203 Vs. Investigator's Choice Of Treatment In Previously Treated, Unresectable Or Metastatic Cutaneous Melanoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.
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MC200404, Safety And Immunogenicity Of PolyPEPI1018 Vaccine In The Treatment Of Late-stage Metastatic Colorectal Cancer
Rochester, MN
The purpose of this study is to investigate the combination of standard of care treatment of TAS-102 and the experimental peptide vaccine, PolyPEPI1018, to learn more about the side effects of combination and to collect information on how cancer responds to this combination.
PolyPEPI1018 peptide vaccine is a mixture of 6 synthetic peptides and the adjuvant Montanide™ and is used to immunize against proteins present on the surface of tumor cells. In a high number of patients, this mixture will activate the body’s immune cells, called T cells. T cells fight infections and can also kill cancer cells.
Participants will receive TAS-102 and PolyPEPI1018 which ...
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CAncer Survivor CArdiomyopathy DEtection (CASCADE) Pilot Study
Rochester, MN
The purpose of this study is to improve the cardiovascular care of adult cancer survivors by contributing much-needed evidence regarding optimal surveillance and treatment recommendations. This application’s objective is to obtain the data necessary to plan an adequately powered randomized clinical trial (RCT) across a nation-wide network that will define prospectively the clinical and economic efficacy of a screening program that uses AI-ECG and/or NT-pro-BNP in an at-risk adult cancer survivor population.
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Cancer-Related Fatigue Amongst Cutaneous Oncology Patients
Rochester, MN
The purpose of this study is to identify the severity of cancer-related fatigue (CRF) amongst cutaneous oncology patients within the dermatologic surgery department at Mayo Clinic Rochester. We aim to delineate the spectrum of CRF as it relates to tumor incidence and patient perception of incidence.
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
La Crosse, WI
The purpose of this research is to determine if previously adding a medication by the name of bevacizumab to the current standard chemotherapy of cancer-reducing medications, namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence (called disease-free survival) compared to standard chemotherapy alone.
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Testing The Addition Of An Anti-cancer Drug, ASTX727, To Chemotherapy (Paclitaxel) And Immunotherapy (Pembrolizumab) For Metastatic Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety, side effects, and best dose of ASTX727 when given together with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic).
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DAREON™-9: A Study To Test How Well Different Doses Of BI 764532 Are Tolerated By People With Small Cell Lung Cancer When Taken Together With A Single Agent Chemotherapy
Jacksonville, FL
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.
The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study ...
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A Study To Optimize Endocrine Therapy Through Motivational Interviewing And Text Interventions
Albert Lea, MN; Rochester, MN
This study aims to compare an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence).
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Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
No Locations
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill ...
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Study Of Trastuzumab Deruxtecan (T-DXd) Vs Investigator's Choice Chemotherapy In HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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Tissue and Blood Registry for Individuals with Liver and Biliary Tumors
Jacksonville, FL
This study will collect and store samples of tissue and blood for current and future research studies on Liver and Biliary Tumors.
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Study Of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) In Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy In Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Jacksonville, FL; Rochester, MN
The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
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A Study To Evaluate Adjuvant Ado-Trastuzumab Emtansine (T-DM1) In HER2 Positive Breast Cancer
Rochester, MN
The purpose of this study is to evaluate an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)
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Hepatobiliary Cancer Research Engagement Among Patients And Communities
Jacksonville, FL
The purpose of this study is to assess community needs and attitudes toward participating in hepatobiliary cancer research for relevant, translatable, and sustainable research partnership.
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A Study Of CTX-009 In Combination With Paclitaxel In Adult Patients With Unresectable Advanced, Metastatic Or Recurrent Biliary Tract Cancers (COMPANION-002)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of CTX-009 in combination with paclitaxel vs. paclitaxel alone in patients with biliary tract cancers (BTC) who have received one systemic therapy for advanced disease, as measured by Overall Response Rate (ORR) assessed by an Independent Central Radiology (ICR) review.
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Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
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Fertility Outcomes in Lymphoma Patients
Jacksonville, FL
The objectives of this study are to analyze impact of radiation on fertility, to correlate the clinical outcome of fertility after chemotherapy and or radiation, and to evaluate the different modalities and cost/benefit of fertility preservation in lymphoma patients
Lymphoma is a diversified disease with outcomes differing upon the types and subtypes of lymphoma as well as treatment modalities used. Fertility outcomes in patients treated with chemotherapy and/or radiation could vary and largely unknown.
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Management of Locoregional Recurrent Breast Cancer
Rochester, MN
The aims of this study are to develop an institutional recurrent breast cancer registry, including prior and future patients, which will be prospectively maintained to characterize the current management of patients with locally recurrent breast cancer. Specifically, investigate the extent of operation, subsequent operations, use of radiation and re-radiation and timing and nature of systemic therapies and variables associated with selection of these modalities, and to analyze breast-cancer specific outcomes including rates of local re-recurrence, regional and distant recurrence, recurrence-free and breast-cancer specific survival.
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A Study Of Treatment For Medulloblastoma Using Sodium Thiosulfate To Reduce Hearing Loss
Rochester, MN
This phase III trial tests two hypotheses in patients with low-risk and average-risk medulloblastoma. Medulloblastoma is a type of cancer that occurs in the back of the brain. The term, risk, refers to the chance of the cancer coming back after treatment. Subjects with low-risk medulloblastoma typically have a lower chance of the cancer coming back than subjects with average-risk medulloblastoma. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects or unintended health conditions that arise due to treatment include ...
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Study Of Magrolimab Combination Therapy To Treat Unresectable, Locally Advanced Or Metastatic Triple-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of the Safety-Run-in Cohort 1 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with nab-paclitaxel or paclitaxel. In Phase 2 Cohort 1, the study will compare the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone as determined by
progression-free survival (PFS) by investigator assessment
The primary purpose of the Safety-Run-in Cohort 2 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with sacituzumab govitecan. In Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) the study will evaluate the efficacy of magrolimab in combination ...
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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...
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Ramucirumab Plus Pembrolizumab Vs Usual Care For Treatment Of Stage IV Or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. I
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Pembrolizumab With Chemotherapy And With/Without MK-4830 For Treating Participants With Ovarian Cancer
Jacksonville, FL
The purpose of this study is to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + Standard of Care (SOC) therapy.
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Study Of Carboplatin And Mirvetuximab Soravtansine In First-Line Treatment Of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube Or Primary Peritoneal Cancer
Rochester, MN
The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive ...
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An Open Label Extension Study Of BMS-911543 In Subjects With Myelofibrosis
Rochester, MN
The purpose of this study is to provide patients with myleofibrosis (MF) who participated in study CA215001 access to BMS-911543.
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Safety And Preliminary Efficacy Of OBT076 In Recurrent/Metastatic CD205+ Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and tolerability of OBT076, and to define the maximum tolerated dose (MTD) and/or the RP2D of OBT076.
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Cryotherapy -BEATS-RF Ablation Trial
Rochester, MN
The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).
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Radioembolization With Tremelimumab And Durvalumab For Locally Advanced Unresectable Or Oligo-Metastatic Intrahepatic Cholangiocarcinoma
Jacksonville, FL
The purpose of this study is to assess the safety and preliminary efficacy of segmental ablative radioembolization in combination with Tremelimumab plus Durvalumab (MEDI4736) in patients with cholangiocarcinoma who are not candidates for curative therapy. transplantation will be enrolled in two cohorts.
The primary objective of the study is to characterize the safety of the combination of Y90 TARE, durvalumab and tremelimumab. As a secondary objective, the study will assess the overall efficacy of Y90 in combination with therapty as guaged by patient response rate.
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Bispecific Aptamer Engagers For Cancer Therapy
Jacksonville, FL
The purpose of this work is to develop brain cancer-specific small synthetic oligonucleotides (aptamers) that easily cross the BBB and capable of forming distinct three-dimensional configurations, enabling them to bind to target molecules with high affinity and specificity. The scope of this work is to develop brain cancer specific aptamers and combine them with patient-derived autologous T cells to enhance the tumor targeted immune reaction.
Our three major project aims are the creation of the Bispecific Aptamer T Cell Engagers (BATE) (aim 1), the creation of autologous T cell – BATE (aim 2), and finally the combination ...
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Human Papilloma Virus (HPV) Circulating Tumor DNA (CtDNA) In Cervical Cancer
Rochester, MN
The purpose of this study is to answer whether plasma circulating tumor DNA (ctDNA) obtained by serial analysis before, during, and following surgery, radiotherapy, chemotherapy, and/or immunotherapy for cervical cancer will allow for risk stratification, individualized treatment decision making, monitoring of treatment response, and early detection of residual or recurrent disease in patients presenting with human papillomavirus (HPV) mediated cervical cancer.
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A Study To Predict Lung Cancer Using Noninvasive Biomarkers
Rochester, MN
The purpose of this study is to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules.
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Adequate Selection Of Patients For Thyroid Biopsy: Evaluation Of A Shared Decision Making Conversation Tool
Eau Claire, WI; Rochester, MN
The purpose of this study is to field test and update an existing conversation aid prototype designed to support shared decision making in the diagnosis and treatment of thyroid cancer, and to conduct a pilot randomized multi-center trial to test the refined conversation aid.
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Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE
Rochester, MN
The aim of this study is to develop a feasible, acceptable, and sustainable comprehensive cancer distress management program that is tailored to the unique needs of cancer patient survivors.
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Defining The Immunologic Profile Of Sentinel Lymph Nodes And Identifying The Mechanisms Responsible For Immunosuppression
Jacksonville, FL; Rochester, MN
The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.
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Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice And Pembrolizumab In Patients With Previously Untreated, Locally Advanced Inoperable Or Metastatic Triple-Negative Breast Cancer (ASCENT-04)
Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
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Testing The Use Of Ado-Trastuzumab Emtansine Compared To The Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) For Recurrent, Metastatic, Or Unresectable HER2-Positive Salivary Gland Cancer
Rochester, MN
The purpose of this study is to test whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them.
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A Study To Evaluate Treatment Of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Rochester, MN
The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
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A Study to Determine if Differences in the Microbe Environment of the Intestines Connects to the Effects of Obesity on Intestinal Stem Cells
Rochester, MN
New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The purpose of this study is to find how the microbe envntironment of the intestines in obesity influences the growth of intestinal stem cells, which could then trigger intestinal tumors.
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A Study To Evaluate The Safety And Efficacy Of Two Dose Levels Of ONO-4578 With Opdivo®, In Combination With MFOLFOX6 And Bevacizumab Versus Standard Of Care In Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
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Breast Cancer WEight Loss Study (BWEL Study)
La Crosse, WI; Albert Lea, MN; Eau Claire, WI; Mankato, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take ...
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Phase 3 Study Of MRTX849 With Cetuximab Vs Chemotherapy In Patients With Advanced Colorectal Cancer With KRAS G12C Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
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A Study Of Tucatinib With Trastuzumab And MFOLFOX6 Versus Standard Of Care Treatment In First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
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A Randomized Phase III Trial Of Eribulin Compared To Standard Weekly Paclitaxel As First- Or Second-Line Therapy For Locally Recurrent Or Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a two arm Phase III trial in first and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression ...
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Study Of Pembrolizumab (MK-3475) As Monotherapy In Participants With Previously-Treated Locally Advanced Unresectable Or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
Rochester, MN
In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability (MSI) high colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan ...
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Orexin Receptor Antagonist In Hospitalized Patients With Cancer To Prevent Delirium
Rochester, MN
The purpose of this study is to use suvorexant in addition to standard delirium precautions in hospitalized adults with insomnia and risk factors for delirium will produce a significant reduction in delirium incidence and severity compared to standard delirium precautions alone
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A Study To Investigate The Da Vinci SP® Surgical System In Colorectal Procedures For Benign And Malignant Disease
Jacksonville, FL; Rochester, MN
The purpose of this study is to confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections.
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Evaluating Intestinal Microbiome And Immune Function In Lymphoma
Rochester, MN
The purpose of this study is to examine the microbiome and immune function in patients with active lymphoma, and in patients with a history of lymphoma who are in clinical remission.
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Oncolytic Adenovirus Coding For TNFa And IL2 (TILT-123) With Pembrolizumab Or Pembrolizumab And Pegylated Liposomal Doxorubicin As Treatment For Ovarian Cancer. (PROTA)
Rochester, MN
The purpose of this study is to evaluate the safety [including dose-limiting toxicities (DLTs)] of the combination therapy of TILT-123 and pembrolizumab in patients with platinum resistant or refractory ovarian cancer.
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A Study Assessing The Effectiveness And Safety Of Alpelisib + Nab-paclitaxel In Subjects With Advanced Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2)
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Randomized, Open Label, Clinical Study Of The Targeted Therapy, Palbociclib, To Treat Metastatic Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
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Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice In Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery And Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
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A Study To Evaluate Immunotherapy And Ovarian Function Among Pre-menopausal Melanoma Survivors
Jacksonville, FL; Rochester, MN
The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.
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Pre-op Pembro + Radiation Therapy In Breast Cancer (P-RAD)
Rochester, MN
The purpose of this trilal is to study a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer.
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Durvalumab+/- Tremelimumab In Combination With Platinum Based Chemotherapy In Untreated Extensive-Stage Small Cell Lung Cancer (Caspian)
Scottsdale/Phoenix, AZ
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer.
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Acceptability of Artificial Intelligence and Machine Learning During Colonoscopy for Polyp Detection
Rochester, MN
The purpose of this study is to understand and assess patients’ current acceptability of machine learning/AI during colonoscopy for polyp detection.Our secondary aims are to determine what factors influence patients’ responses and to determine the various thresholds in adenoma detection rate (ADR) that would be acceptable to patients.
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A Phase I, Multi-Center, Open Label, Dose De-escalation And Expansion Study Of Gemcitabine And Cisplatin With AG120 Or Pemigatinib For Advanced Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of gemcitabine and cisplatin when given together with ivosidenib or pemigatinib in treating patients with cholangiocarcinoma that cannot be removed with surgery (unresectable) or has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib and pemigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for ...
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A Study To Evaluate The Safety And Effectiveness Of TT-00420 In Adults With Advanced Cholangiocarcinoma
Rochester, MN
The purpose of this trial is to evaluate the effectiveness and safety of TT-00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment and discontinued due to disease progression, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.
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A Study Of Rilvegostomig Plus Chemotherapy As Adjuvant Therapy For Biliary Tract Cancer After Resection
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effictiveness and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
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Natural History Evaluation Among Female Breast Cancer Survivors With Endocrine Therapy-Induced Alopecia
Albert Lea, MN; Mankato, MN; Rochester, MN
The purpose of this study is to learn about potential side effects facing people who are undergoing treatments for their cancer, specifically, hair loss. While this is not a well-documented side effect of hormone-blocking medications (such as tamoxifen, letrozole, anastrozole, or exemestane), we have preliminary evidence that it is a problem for some patients getting this treatment. This study will include some patients receiving the hormone therapy and some patients who are not, so we can better understand whether patients getting the hormonal therapy have more hair loss than patients who are not getting such.
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Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, And Rucaparib In Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, Or Biliary Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of these phase I/II trial studies is to analyze the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium, and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body. Drugs used in chemotherapy, such as liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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A Study To Evaluate The Effect Of Diet And Exercise On Biomarkers Associated With Obesity And Breast Cancer In Overweight Women With Early Stage Breast Cancer
Rochester, MN
The primary purpose of this study is to investigate the relationship between a technology-assisted diet and exercise program which is easily implemented in an outpatient setting and the levels of biomarkers that have been associated with breast cancer recurrence risk in overweight women with stage 0, I, or II breast cancer.
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Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.
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A Study To Evaluate Carboplatin-paclitaxel With Retifanlimab Or Placebo In Participants With Locally Advanced Or Metastatic Squamous Cell Anal Carcinoma
Rochester, MN
The purpose of this study is to compare the effectiveness of Carboplatin-Paclitaxel with INCMGA00012 vs. Carboplatin-Paclitaxel with placebo in participants with inoperable, locally-advanced or metastatic Squamous Cell Anal Carcinoma (SCAC) not previously treated with systemic chemotherapy.
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A Study To Test The Addition Of Berzosertib To Usual Radiation Treatment For Chemotherapy-Resistant Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose twice weekly of berzosertib administered concurrently with conventionally fractionated radiation therapy to the breast/chest wall and regional nodes.
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A Study To Evaluate Abemaciclib For Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.
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An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 In Combination With Soc, Versus SoC Alone, In Adult Male Patients With MHSPC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy.
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BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors In Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts In Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) And Pancreatic Adenocarcinoma (PDA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 in combination with irinotecan or topotecan at different doses.
Irinotecan has already been approved by the FDA to treat pancreatic cancer while topotecan has already been approved by the FDA to treat small cell lung cancer.
Another purpose of the study is to check the level of the study drugs in your blood called pharmacokinetics or PK and to see if there are changes in levels of circulating tumor cells in your blood. To assess what effect the study ...
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Ramucirumab And Paclitaxel Or FOLFIRI In Advanced Small Bowel Cancers
Rochester, MN
This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop ...
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Cancer Distress Management Program for Liver and Biliary Cancer within a SPORE
Rochester, MN
The aim of this study is to develop a feasible, acceptable, and sustainable comprehensive cancer distress management program that is tailored to the unique needs of cancer patient survivors.
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Defining The Immunologic Profile Of Sentinel Lymph Nodes And Identifying The Mechanisms Responsible For Immunosuppression
Jacksonville, FL; Rochester, MN
The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.
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Study Of Sacituzumab Govitecan-hziy And Pembrolizumab Versus Treatment Of Physician's Choice And Pembrolizumab In Patients With Previously Untreated, Locally Advanced Inoperable Or Metastatic Triple-Negative Breast Cancer (ASCENT-04)
Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
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Testing The Use Of Ado-Trastuzumab Emtansine Compared To The Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) For Recurrent, Metastatic, Or Unresectable HER2-Positive Salivary Gland Cancer
Rochester, MN
The purpose of this study is to test whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them.
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A Study To Evaluate Treatment Of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Rochester, MN
The purpose of this study is to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
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A Study To Evaluate Gemcitabine Hydrochloride And Cisplatin With Or Without Nab-Paclitaxel In Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
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Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Rochester, MN
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts will undergo endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This is a pilot study to assess safety and efficacy.
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National Wilm's Tumor Study Late Effects
Rochester, MN
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.
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A Study To Evaluate The Effectiveness And Safety Of Relacorilant
Rochester, MN
The purpose of this study is to assess the effectiveness of Relacorilant for the treatment of hypercortisolism in patients with cortisol-secreting adrenal adenomas or hyperplasia, based on glycemic and blood pressure (BP) control at Week 22 compared with placebo. and to assess the safety of relacorilant for the treatment of hypercortisolism.
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A Study To Evaluate AMG 701 In Subjects With Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine (during the escalation portion) if AMG 701 given as weekly short term IV infusions is safe and tolerable followed by a dose expansion part to gain further efficacy and safety experience with AMG 701 in adult subjects with relapsed / refractory multiple myeloma.
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Implementation Of Meaning-Centered Psychotherapy For Veterans With Advanced Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness of MCP on depression, psychosocial distress, and QOL in veterans with advanced cancer. This study will also evaluate participants’ perception of MCP to better guide future use of the intervention at Mayo Clinic.
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MMRC Horizon One Adaptive Platform Trial Evaluating Therapies In RRMM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol.
The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.
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Identifying Gene Modifiers Of Melanoma And Pancreatic Cancer Susceptibility
Rochester, MN
The purpose of this study is to understand the interplay of factors increasing susceptibility and expression of pancreatic cancer and melanoma to develop new diagnostic and chemopreventive regimens.
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Role Of Immunity In Efficacy Of Chemotherapy Plus Trastuzumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate T cell and antibody immunity in patients with HER2+ breast cancer who will receive trastuzumab with standard chemotherapy in order to address whether the immunity is associated with the patient’s response to treatment.
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A Study To Examine Quality Of Life Assessment In Patients Receiving Cryotherapy For Palliation Of Dysphagia In Unresectable Esophageal Or Gastroesophageal Junctional Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effect of endoscopic cryoablation for lessening the effects of dysphagia on the quality of life (QOL) of patients with unresectable esophageal or gastroesophageal junctional cancer.
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Phase Ib/II Of TG4001 And Avelumab In HPV16 Positive R/M Cancers
Jacksonville, FL; Rochester, MN
The study will consist of two parts. The purpose of Phase Ib is to evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. The purpose of Phase II part 1 is to evaluate the effectiveness of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal SCCHN. The purpose of Phase II part 2 is to compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic ...
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A Randomized Phase 2 Study Of Combination Atezolizumab And CDX-1127 (Varlilumab) With Or Without Addition Of Cobimetinib In Previously Treated Unresectable Biliary Tract Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the response rate (ORR) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib, and to assess the progression free survival (PFS) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib.
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Niraparib In Combination With Trastuzumab In Metastatic HER2+ Breast Cancer
Rochester, MN
The purpose of this study is to evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.
The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer.
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A Study Of Tucatinib Or Placebo With Trastuzumab And Pertuzumab For Metastatic HER2+ Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body ...
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A Global, Randomized, Placebo-controlled Phase 3 Study Of Fruquintinib In Patients With Refractory Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
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Advancing Skin Cancer Prevention And Treatment Through DNA Repair Enzymes: A Clinical Approach In Solid Organ Transplant Recipients
Jacksonville, FL
The purpose of this study is to determine whether the application of topical DNA repair enzymes results in a statistically significant reduction in facial photodamage compared to sunscreen alone in solid organ transplant recipients (SOTRs).
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Biorepository For Acute Leukemia Research
Rochester, MN
The purpose of this IRB protocol is to establish a specimen bank for research into acute leukemias. In particular, we plan to bank blood and bone marrow from patients with newly diagnoses or relapsed acute leukemia (AML or ALL) for future biological studies. By accruing samples both at initial diagnosis and at relapse, we will be able to investigate not only the biology of these marrow disorders, but also the changes that occur to render these disorders resistant to therapy. These activities are a first step toward identifying alternative therapies and subsequently beginning to personalize the therapy for these disorders.
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Radiation Therapy With Or Without Temozolomide In Treating Patients With Low-Grade Glioma
Jacksonville, FL; Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.
PURPOSE: This randomized phase III trial is studying radiation therapy ...
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A Study To Evaluate The Impact On Metastases-free Survival With The Addition Of Saruparib Versus Placebo To A Standard Radiotherapy/androgen Deprivation Regimen In Men With High-risk Prostate Cancer With A BRCA Mutation.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to evaluate the impact on metastases-free survival with the addition of saruparib versus placebo to a standard RT + ADT regimen in men with high-risk and very high-risk (localised/locally advanced) prostate cancer with a BRCAm.
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Tools To Evaluate Treatment Tolerability In Older Patients With Sarcoma
Rochester, MN
Sarcomas are rare, encompass multiple subtypes, and have few established guidelines. Geriatric assessments and screening tools are recommended as part of multi-disciplinary care for older patients with cancer, but they are not widely used in clinical practice. This pilot study will prospectively evaluate older patients (age 65 years and above) with sarcoma who are followed in the medical oncology sarcoma clinic in Rochester MN; this will include patients who are newly diagnosed or receiving systemic therapy. Patients will undergo geriatric screening as well as laboratory testing. Laboratory testing will include routine complete blood counts (CBC) that are associated ...
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A Study To Evaluate Hemorrhage And Thrombosis In Hematology Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to determine: the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia, and recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia.
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Study Of Safety And Efficacy Of Iberdomide (CC-220) And CC-99282 Combined With R-CHOP To Treat Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of Part 1 of this study is to define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-220 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone given in 21-day treatment cycles (R-CHOP-21) and CC99282 in combination with R-CHOP-21 in subjects with previously untreated, high risk (International Prognostic Index [IPI] 3 to 5), a-BCL.
The primary objective of Part 2 of this study is to further evaluate the safety and tolerability associated with CC-220 and CC-99282 at the RP2D in combination with R-CHOP-21 in subjects with previously untreated, high-risk (IPI 3 to 5), a-BCL.
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Changes In Blood Components In Patients With Ovarian Cancer
Rochester, MN
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
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Anesthesia And Non-small Cell Lung Cancer Recurrence
Jacksonville, FL
There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.
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A Registry For The Collection And Maintenance Of Biological Specimens For Breast Cancer Research
Rochester, MN
The purpose of this registry is to collect and maintain samples of breast tissue from women and men undergoing surgery for a breast related concern at Mayo Clinic Rochester, to create a biospecimen resource for the study of benign and cancerous breast conditions.
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IRB#21-009968: Assessing the Sexual Health and Well-Being of Female Survivors of Pelvic Malignancies after Radiotherapy
Rochester, MN
The purpose of this study is to quantify the extent of sexual dysfunction in our patients to explore if there is a need for a prospective intervention, with the ultimate goal of improving the quality of life of our patients, with respect to sexual function.
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Inherited Breast Cancer Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to improve the interpretation of mutations in breast cancer predisposition genes. This will be accomplished by recruiting members of families found to carry deleterious (mainly protein truncating) mutations and evaluating co-segregation of the mutations with cancer within families.
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Study Of 225Ac-ABD147 To Establish Optimal Dose In Patients With SCLC And LCNEC Of The Lung That Previously Received Platinum-based Chemotherapy
Jacksonville, FL; Rochester, MN
The study has 2 parts, Phase 1a and Phase 1b. The goal of Phase 1a is to gather safety, PK and initial efficacy data for 225Ac-ABD147 to better understand best doses for patients with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) of the lung following platinum-based chemotherapy.
An initial group of patients will also be given an experimental imaging agent called 111In-ABD147 to help understand where ABD147 goes in the body.
The goal of Phase 1b is to gather additional safety and efficacy data on 225Ac-ABD147 to determine the best dose and to understand how those doses affect ...
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Leveraging AI/ML Algorithms On Digital Pathology And Ex-Vivo Confocal Microscopy Imaging For Extramammary Paget’s Disease
Rochester, MN
The purpose of this study is to validate the use of ex-vivo confocal microscopy for the assessment of skin specimens derived from Mohs surgery compared to standard microscopy. To leverage deep learning models for classification, detection, and localization of tumor for extramammary Paget’s disease on ex-vivo confocal microscopy images. To leverage AI/ML to ex-vivo confocal microscopy imaging to facilitate microscopic-level imaging of extramammary Paget’s disease. To leverage deep learning models for classification, detection, and localization of tumor for extramammary Paget’s disease on frozen and permanent pathology WSIs.
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Male Breast Cancer: Understanding The Biology For Improved Patient Care
Rochester, MN
Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease.
Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from 1990 to 2010.
Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months (starting early 2014).
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A Phase 1b Trial Of ATRC-101 In Adults With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.
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Intravital Microscopy (IVM) In Patients With Peritoneal Carcinomatosis (PC)
Jacksonville, FL
This study will investigate the tumor-associated vasculature of patients with peritoneal carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the tumor-associated vessels of peritoneal disease. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.
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A Study To Evaluate The Effectiveness And Safety Of Pemigatinib Versus Chemotherapy In Unresectable Or Metastatic Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
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Combination Chemotherapy in Treating Women With Breast Cancer
No Locations
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.
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Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.
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A Study to See if Ultrasound Shear Wave Elastography Can Find Early Heart Muscle Damage from Chemotherapy in Cancer Patients
Rochester, MN
The purpose of this study is see if a new ultrasound-based technique similar to standard clinical echocardiography, called Shear Wave Elastography, can provide reliable early detection of heart muscle damage caused by chemotherapy.
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Patient Outcomes After Hepatic Artery Infusion Pump Placement
Rochester, MN
The purpose of this study is to evaluate the short-term outcomes and the quality of life (QOL) after cholecystectomy and hepatic artery infusion pump placement for localized unresectable colorectal liver metastases (CRLM).
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PLX038 For The Treatment Of Metastatic Ovarian, Peritoneal, And Fallopian Tube Cancers
Rochester, MN
The purpose of this study is to determine the response rate to PLX-038 in patients with metastatic ovarian, primary peritoneal, and fallopian tube cancers that are resistant to platinum drugs.
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A Study To Evaluate The Combination Of Binimetinib And Palbociclib In Treating Patients With KRAS And NRAS Mutant Metastatic Or Unresectable Colorectal Cancer
Scottsdale/Phoenix, AZ
The purose of this study is to determine how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib ...
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A Study To Understand Attitudes Towards Hepatitis Viral Load Testing That Could Impact Testing Rates
Jacksonville, FL; Rochester, MN
The purpose of this study is to understand if there are race-specific or other demographic-specific attitudes about voluntary testing for hepatitis B and C virus infection and return of individual research results that could have implication for an individual's risk of developing hepatitis-related liver cancer. Understanding these attitudes is a necessary first step to developing effective intervention strategies for liver cancer prevention.
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A Phase 1 Study Of The Safety And Tolerability Of MT-125 In GBM Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.
Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.
Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to ...
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Heated Intraperitoneal Chemotherapy Followed By Niraparib For Ovarian, Primary Peritoneal And Fallopian Tube Cancer (HOTT)
Rochester, MN
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC ...
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Measuring If Immunotherapy Plus Chemotherapy Is Better Than Chemotherapy Alone For Patients With Aggressive Poorly Differentiated Sarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.
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Investigation Of Ubamatamab Combination Therapy In Adult Participants With Platinum-Resistant Ovarian Cancer
Jacksonville, FL
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug and its experimental combinations * How much study drug ...
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SULF1 and SULF2 Role in Cholangiocarcinoma
Rochester, MN
Cholangiocarcinoma (CCA) has key similarities with HCC, therefore, we hypothesize that Sulf1 and Sulf2 may also play roles in promotion of CCA progression.
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A Study of the Development and Validation of an Ascites-Specific Patient Reported Outcomes Questionnaire
Rochester, MN
The purpose of this study is to develop and validate a brief patient reported outcomes questionaire that is responsive to ascites-related symptoms in liver cirrhosis.
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Semen Analysis In Chemotherapy
Rochester, MN
The purpose of this study is to correlate the impact of chemotherapy on semen analysis and the disease-free survival of patients undergoing gonadotoxic treatment for leukemia or lymphoma.
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A Study To Detect Actionable Or Predictive Tumor DNA Mutations In Peripheral Blood (Liquid Biopsy) From Patients With Cholangiocarcinoma (CCA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the feasibility of isolating circulating tumor cells (CTCs) and cfDNA from patients with CCA for molecular characterization and compare the mutation results between peripheral blood and tumor tissue.
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Staging Of Superficial EAC Using VLE
Rochester, MN
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
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A Study Of APR-246 And Pembrolizumab In Patients With Solid Tumor Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
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Z-Endoxifen Hydrochloride in Treating Patients with Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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DNA Damage Using HERY-MNT Technology Can Predict Chemotherapy Induced Toxicity In Women With Ovarian Cancer
Rochester, MN
The purpose of this study is to understand changes that take place in the blood of patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This portion of the study is to understand the changes that occur in your blood during and after treatment with carboplatin and paclitaxel chemotherapy in women with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
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Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients with Refractory or Relapsed Neuroblastoma
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them ...
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Rochester, MN
This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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Understanding Treatment Preferences In Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this research is to understand how people with lymphoma make decisions about treatment and why. Study participation involves partaking in one virtual focus group session with a group of up to 8 people with lymphoma and up to two group moderators. Participants will be asked questions about what they prefer in a lymphoma treatment and how they have made decisions on treatment of their lymphoma in the past. Questions may be about past experiences as well as future hypothetical situations. We hope that what we learn from these discussions will help us to improve care for people ...
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MV-NIS Or Investigator's Choice Chemotherapy In Treating Patients With Ovarian, Fallopian, Or Peritoneal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
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A Study Of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared To Pembrolizumab Alone In People With Previously Untreated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...
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A Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Fruquintinib In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.
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Reishi Mushroom Extract For Fatigue And/or Arthralgias/Myalgias In Patients With Breast Cancer On Aromatase Inhibitors
Albert Lea, MN; Mankato, MN; Rochester, MN
This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and ...
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Ga-DOTATATE PET For Localization Of Phosphaturic Mesenchymal Tumors In Patients With Tumor Induced Osteomalacia
Rochester, MN
This study aims to identify cases of FGF23-mediated oncogenic osteoomalacia in which the underlying phosphaturic mesenchymal has not been found and perform 68Ga-DOTATATE PET in these patients to localize the tumor.
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Genetic Analysis In Blood And Tumor Samples From Patients With Advanced Or Metastatic Estrogen Receptor Positive And HER2 Negative Breast Cancer Receiving Palbociclib And Endocrine Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
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Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
Rochester, MN
This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. - Paclitaxel (also called Taxol) - Doxorubicin also called Adriamycin - Cyclophosphamide, also called Cytoxan
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Simplified Patient Care Strategy In Decreasing Early Death In Patients With Acute Promyelocytic Leukemia
Jacksonville, FL; Rochester, MN
This clinical trial studies how well simplified patient care strategy works in decreasing early death in patients with acute promyelocytic leukemia. Implementing simplified acute promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival.
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Measuring If Immunotherapy Plus Chemotherapy Is Better Than Chemotherapy Alone For Patients With Aggressive Poorly Differentiated Sarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.
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Heated Intraperitoneal Chemotherapy Followed By Niraparib For Ovarian, Primary Peritoneal And Fallopian Tube Cancer (HOTT)
Rochester, MN
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC ...
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Investigation Of Ubamatamab Combination Therapy In Adult Participants With Platinum-Resistant Ovarian Cancer
Jacksonville, FL
This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer. The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug and its experimental combinations * How much study drug ...
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A Study to Evaluate ctDNA Diagnostics in Recurrent Breast Cancer Patients
Rochester, MN
The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.
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A Study in Second Line Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the overall survival with ramucirumab combined with FOLFIRI or a placebo and FOLFIRI in patients who have metastatic colorectal cancer.
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SC16LD6.5 in Recurrent Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of ...
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The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Jacksonville, FL; Rochester, MN
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
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A Phase III, Randomised Study Of Adjuvant Dato-DXd In Combination With Rilvegostomig Or Rilvegostomig Monotherapy Versus Standard Of Care, Following Complete Tumour Resection, In Participants With Stage I Adenocarcinoma NSCLC Who Are CtDNA-positive Or Have High-risk Pathological Features
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
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A Study To Evaluate The Adverse Events, And Efficacy Of Intravenous (IV) Of Telisotuzumab Adizutecan In Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab In Adult Participants With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and ...
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Pilot Study Of Antineoplastic
Rochester, MN
The purpose of this study is to use therapeutic drug monitoring (trough plasma concentrations of dabrafenib, hydroxy dabrafenib, and/or trametinib) along with CYP3A4/CYP3A5 and CYP2C8 genotyping and BRAF mutation quantification will correlate with effectiveness (based on imaging studies) and/or toxicity (pyrexia, liver dysfunction, rash) in known melanoma patients.
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A Study To Evaluate The Safety And Effectiveness Of AB928-Based Treatment Combinations To Treat Patients With Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the clinical activity, safety and tolerability of etruma-based treatment combinations.
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A Study Evaluating The Efficacy Of Venetoclax Plus Ibrutinib In Subjects With T-cell Prolymphocytic Leukemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows:
Stage 1: Enroll up to 14 participants and move to Stage 2 if 4 or more subjects meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.
Stage 2: Enroll up to an additional 23 participants with previously untreated or relapsed or refractory T-PLL.
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A Study To Evaluate TG4050 In Ovarian Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability, as well as some activity parameters, of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.
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Evaluating Intraoperative Indocyanine Green Dye Fluorescence Angiography For Sarcoma Resectiong
Rochester, MN
The purpose of this study is to evaluate the use of ICG as an intraoperative guide during bone and soft tissue sarcoma resection to determine if ICG fluorescence will be an accurate, real-time, intraoperative margin detector during resection of musculoskeletal sarcomas.
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A Study To Compare Administering Olaparib Concurrently With Radiotherapy Vs. Radiotherapy Alone In Treating Patients With Inflammatory Breast Cancer
Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
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YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or ...
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A Global, Randomized, Placebo-controlled Phase 3 Study Of Fruquintinib In Patients With Refractory Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
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Advancing Skin Cancer Prevention And Treatment Through DNA Repair Enzymes: A Clinical Approach In Solid Organ Transplant Recipients
Jacksonville, FL
The purpose of this study is to determine whether the application of topical DNA repair enzymes results in a statistically significant reduction in facial photodamage compared to sunscreen alone in solid organ transplant recipients (SOTRs).
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Biorepository For Acute Leukemia Research
Rochester, MN
The purpose of this IRB protocol is to establish a specimen bank for research into acute leukemias. In particular, we plan to bank blood and bone marrow from patients with newly diagnoses or relapsed acute leukemia (AML or ALL) for future biological studies. By accruing samples both at initial diagnosis and at relapse, we will be able to investigate not only the biology of these marrow disorders, but also the changes that occur to render these disorders resistant to therapy. These activities are a first step toward identifying alternative therapies and subsequently beginning to personalize the therapy for these disorders.
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Radiation Therapy With Or Without Temozolomide In Treating Patients With Low-Grade Glioma
Jacksonville, FL; Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.
PURPOSE: This randomized phase III trial is studying radiation therapy ...
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A Study To Evaluate The Impact On Metastases-free Survival With The Addition Of Saruparib Versus Placebo To A Standard Radiotherapy/androgen Deprivation Regimen In Men With High-risk Prostate Cancer With A BRCA Mutation.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to evaluate the impact on metastases-free survival with the addition of saruparib versus placebo to a standard RT + ADT regimen in men with high-risk and very high-risk (localised/locally advanced) prostate cancer with a BRCAm.
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Tools To Evaluate Treatment Tolerability In Older Patients With Sarcoma
Rochester, MN
Sarcomas are rare, encompass multiple subtypes, and have few established guidelines. Geriatric assessments and screening tools are recommended as part of multi-disciplinary care for older patients with cancer, but they are not widely used in clinical practice. This pilot study will prospectively evaluate older patients (age 65 years and above) with sarcoma who are followed in the medical oncology sarcoma clinic in Rochester MN; this will include patients who are newly diagnosed or receiving systemic therapy. Patients will undergo geriatric screening as well as laboratory testing. Laboratory testing will include routine complete blood counts (CBC) that are associated ...
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A Study To Evaluate Hemorrhage And Thrombosis In Hematology Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to determine: the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia, and recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia.
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Study Of Safety And Efficacy Of Iberdomide (CC-220) And CC-99282 Combined With R-CHOP To Treat Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of Part 1 of this study is to define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-220 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone given in 21-day treatment cycles (R-CHOP-21) and CC99282 in combination with R-CHOP-21 in subjects with previously untreated, high risk (International Prognostic Index [IPI] 3 to 5), a-BCL.
The primary objective of Part 2 of this study is to further evaluate the safety and tolerability associated with CC-220 and CC-99282 at the RP2D in combination with R-CHOP-21 in subjects with previously untreated, high-risk (IPI 3 to 5), a-BCL.
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Changes In Blood Components In Patients With Ovarian Cancer
Rochester, MN
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
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Anesthesia And Non-small Cell Lung Cancer Recurrence
Jacksonville, FL
There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.
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Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma
No Locations
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid when given together with combination chemotherapy in treating patients with newly diagnosed metastatic osteosarcoma.
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ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to test an experimental combination of two drugs, ABT-888 and Cyclophosphamide (CP), which we hope may eventually lead to promising new therapies for cancer.
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Minimally Invasive Groin Dissection for Melanoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.
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Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Jacksonville, FL; Rochester, MN
This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others ...
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Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and ...
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A Study To Collect Clinical Data And Store Samples Of Blood And Tissue For Current And Future Research Studies On Sarcoma
Jacksonville, FL
This study is being done to collect clinical data and store samples of your blood and tissue for current and future research studies on sarcoma.
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Isotretinoin With or Without Monoclonal Antibody Ch14.18, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
Rochester, MN
This partially randomized phase III trial studies isotretinoin with monoclonal antibody Ch14.18, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as monoclonal antibody Ch14.18, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to ...
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Gemcitabine Plus Cisplatin With Or Without Bintrafusp Alfa (M7824) In Participants With 1L Biliary Tract Cancer (BTC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) or progression-free survival (PFS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.
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Metformin Hydrochloride And Combination Chemotherapy In Treating Patients With Stage III-IV Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
Rochester, MN
This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors ...
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A Study To Evaluate Larotrectinib To Treat Patients With Previously Untreated TRK Fusion Solid Tumors And TRK Fusion Relapsed Acute Leukemia
Rochester, MN
The purpose of this study is to evaluate the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Investigations Of Reproductive Cancers In Women (PROACTION:)
Rochester, MN
The purpose of this study is to validate a non-invasive diagnostic test with both high-sensitivity and negative predictive value (NPV) for its ability to rule out endometrial cancer.
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A Study To Evaluate Encorafenib Plus Cetuximab With/without Chemotherapy To Treat Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).
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A Study Of Grapiprant And Pembrolizumab In Patients With Advanced Or Progressive MSS Colorectal Cancer
Scottsdale/Phoenix, AZ
This study will be conducted in adult participants diagnosed with any form of an advanced or progressive MSS CRC for which 1st and 2nd line standard therapy (at least one of which contained fluorouracil) is no longer effective or is intolerable. The purpose of this study is to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate and characterize the PK of grapiprant alone and in combination with pembrolizumab. Disease response, pharmacodynamics, and response biomarkers will also be assessed.
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A Study To Evaluate Belinostat And Guadecitabine Or ASTX727 To Treat Unresectable And Metastatic Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess how well belinostat and SGI-110 (guadecitabine) or ASTX727 work in treating patients with conventional chondrosarcoma that cannot be removed by surgery (unresectable) and has spread to other places in the body (metastatic). Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as guadecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving belinostat and guadecitabine may lower the chance of chondrosarcoma growing or ...
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A Phase 1b/2 Study Of Onvansertib (PCM-075) In
Combination With FOLFIRI And Bevacizumab For
Second-Line Treatment Of Metastatic Colorectal Cancer
in Patients With A KRAS Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and effectiveness of Onvansertib, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.
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A Study to Better Understand Carcinogenetic Progression in Cholangiocarcinoma
Rochester, MN
The purpose of this study is to develop a better understanding of the carcinogenetic progression in cholangiocarcinoma and also to develop more accurate diagnostic tests.
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Collection of Lung Tumor Tissue for Current and Future Investigations into Lung Cancer Biology, Pathophysiology, and Epidemiology
Jacksonville, FL
The purpose of this study is to collect lung tumor tissue and blood for current lung cancer related research in Cancer Biology, and to develop and maintain a repository of fresh-frozen lung tumor tissue and blood to support future basic and translational research on lung cancer biology, pathophysiology, and epidemiology.
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Evaluation Of PCLs Using Three EUS-FNA Needles
Scottsdale/Phoenix, AZ; Jacksonville, FL
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
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Clinical Trial Of The ATM-Inhibitor WSD0628 In Combination With Radiation Therapy For Recurrent Brain Tumors
Rochester, MN
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
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Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this stduy is to examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
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A Study Of Endometrial Cancer Testing With Vaginal And Endometrial Cell Samples
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to collect vaginal and endometrial cell samples to study endometrial cancer.
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Phase 3 Study Of T-DXd And Rilvegostomig Versus SoC In Advanced HER2-expressing Biliary Tract Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
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Optical And Biochemical Biomarkers In Early Pancreatic Cancer
Jacksonville, FL
The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.
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Melanoma Registry
Jacksonville, FL
The purpose of this study is to develop and maintain a registry database of all patients treated for a melanoma or a suspected metastatic lesion from a melanoma primary at MCF.
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A Study To Assess Clonal Diversity Of Freshly Taken ESD Specimens
Rochester, MN
Inclusion Criteria:
- Patients with Barrett’s Esophagus (BE) or Esophageal Adenocarcinoma (EAC) that are planned for Endoscopic Submucosal Dissection (ESD) treatment.
Exclusion Criteria:
- Patients without BE or EAC or that are not planned for ESD treatment.
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Evaluating Markers Which Might Be A Predictor Of Pancreatic Cancer Or Precancer By Analyzing The Secretions (Fluid) From A Pancreatic Cyst
Rochester, MN
The purpose of this study is to evaluate molecular markers which might be a predictor of pancreatic cancer or precancer by analyzing the secretions (fluid) from a pancreatic cyst, pancreas fluid and tissue from a resected pancreatic cyst.
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Parotidectomy QOL Score
Rochester, MN
The objectives of this study are to explore the quality of life value of various surgical and functional outcomes after parotidectomy from a patient-centered perspective, develop a comprehensive patient-centered outcome measure after parotidectomy using a patient survey, and to validate the content of the above survey.
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Endoscopic Radiofrequency Ablation Induced Tumor Microenvironment Remodeling In Cholangiocarcinoma
Rochester, MN
The objective of the study is to study the systemic immunological effects of Radiofrequency Ablation in patients with advanced Extrahepatic cholangiocarcinoma.
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Evaluating The Addition Of The Immunotherapy Drug Atezolizumab To Standard Chemotherapy Treatment For Advanced Or Metastatic Neuroendocrine Carcinomas That Originate Outside The Lung
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
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A Study To Evaluate Tucatinib Plus Trastuzumab And Oxaliplatin-based Chemotherapy For HER2+ Gastrointestinal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.
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Diagnosing Lymphangioleiomyomatosis from Glycoprotein Non-Metastatic Melanoma Protein B
Rochester, MN
The purpose of this study is to analyze if levels of glycoprotein non-metastatic melanoma protein B be elevated in patients with LAM..
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Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
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Ultrasound-guided Tissue Acquisition Of Hepatic Draining Lymph Nodes In The Evaluation Of Unresectable Perihilar Cholangiocarcinoma
Jacksonville, FL
The purpose of this study is to test the feasibility of NanoString digital spatial profiling (DSP) and RNAscope™ on prospectively acquired HDLN tissue samples with EUS-FNB in patients with unresectable perihilar CCA undergoing liver transplant (LT) evaluation.
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A Study To Evaluate Trifluridine/Tipiracil In Combination With Irinotecan To Treat Biliary Tract Cancers
Rochester, MN
The purpose of this study is assess the effectiveness of trifluridine/tipiracil plus irinotecan in treating advanced, refractory biliary tract cancers (BTCs).
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Patient Self-sampling Of HPV To Screen For Cervical Cancer
Rochester, MN
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.
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A Study Of AMG 757 In Participants With Neuroendocrine Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and tolerability of AMG 757, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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A Study Of RLY-4008 In Patients With Intrahepatic Cholangiocarcinoma And Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to define the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D), safety profile, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of RLY-4008 in patients with ICC and other advanced solid tumors.
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Ph1b/2 Dose-Escalation Study Of Entinostat With Pembrolizumab In NSCLC With Expansion Cohorts In NSCLC, Melanoma, And Colorectal Cancer
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer
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A Study to Better Understand Carcinogenetic Progression in Cholangiocarcinoma
Rochester, MN
The purpose of this study is to develop a better understanding of the carcinogenetic progression in cholangiocarcinoma and also to develop more accurate diagnostic tests.
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Collection of Lung Tumor Tissue for Current and Future Investigations into Lung Cancer Biology, Pathophysiology, and Epidemiology
Jacksonville, FL
The purpose of this study is to collect lung tumor tissue and blood for current lung cancer related research in Cancer Biology, and to develop and maintain a repository of fresh-frozen lung tumor tissue and blood to support future basic and translational research on lung cancer biology, pathophysiology, and epidemiology.
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Evaluation Of PCLs Using Three EUS-FNA Needles
Scottsdale/Phoenix, AZ; Jacksonville, FL
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
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Clinical Trial Of The ATM-Inhibitor WSD0628 In Combination With Radiation Therapy For Recurrent Brain Tumors
Rochester, MN
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
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Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this stduy is to examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
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A Study Of Endometrial Cancer Testing With Vaginal And Endometrial Cell Samples
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to collect vaginal and endometrial cell samples to study endometrial cancer.
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Phase 3 Study Of T-DXd And Rilvegostomig Versus SoC In Advanced HER2-expressing Biliary Tract Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
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Optical And Biochemical Biomarkers In Early Pancreatic Cancer
Jacksonville, FL
The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.
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Establishment of a Biorepository of Baseline and Follow-up Saliva Samples Collected from Newly Diagnosed, Treatment-naïve Cancer Patients
Jacksonville, FL
The ultimate goal of this biobank will be to provide the resource to initiate an exploration of human saliva as a potential liquid biopsy for cancer detection and surveillance.
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Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
No Locations
The purpose of this study is:
- To assess whether a team based care model applied to distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
- To assess whether health promotion tools such as psychoeducation applied to non-distressed breast cancer patients will result in lower distress at 3, 6, 9 & 12 months compared to treatment as usual.
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A Study to See if New Device Technology Can Tell the Difference Between Non-cancer and Cancerous Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to use new technology called Optical Transfer Diagnosis (OTD) to find if skin lesions are melanomas or non cancer. The research study team wants to see if the Balter Medical OTD technology will identify these lesions the same or better than a dermatologist.
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Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim, And Cyclophosphamide In Treating Patients With Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better ...
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A Study To Evaluate Combination Therapy To Treat Newly-diagnosed Diffuse Anaplastic Wilms Tumors And Relapsed Favorable Histology Wilms Tumors
A Study Of Combination Chemotherapy For Patients With Newly Diagnosed DAWT And Relapsed FHWT
Rochester, MN
The purpose of this study is to evaluate how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
This trial may help doctors find out what effects, good and/or bad, regimen UH-3 ...
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Study Comparing Tarlatamab And Durvalumab Versus Durvalumab Alone In First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide And Durvalumab (DeLLphi-305)
Rochester, MN
The purpose of this study is to compare the effectiveness of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
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Phase 2 Study Of Inhaled Lipid Cisplatin In Pulmonary Recurrent Osteosarcoma
Rochester, MN
To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.
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MR-Guided Laser Ablation of Hepatic Tumors
Rochester, MN
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.
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Automated Renal Characterization, Tumor Identification and Classification (ARCTIC) on Abdominal CT Scan
Rochester, MN
The purpose of this study is to evaluate the accuracy and application of an AI tool to abdominal CT images obtained during routine clinical care for patients with kidney tumors.
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Testing The Effects Of Oxybutynin For The Treatment Of Hot Flashes In Men Receiving Hormone Therapy For Prostate Cancer
Rochester, MN
This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.
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A Study To Collect And Correlate The Data From Multiple Risk Assessments For Heart Toxicity In Patients Receiving Chemotherapy For Breast Cancer
Rochester, MN
The purpose of this study is to collect and correlate the data from various cardiovascular risk asessments to successfully measure the risk of heart toxicity in patients receiving chemotherapy for breast cancer.
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Transbronchial Biopsy Assisted By Robot Guidance In The Evaluation Of Tumors Of The Lung
Scottsdale/Phoenix, AZ
The primary objective of this trial is to determine safety of the robotic bronchoscopy procedures performed in routine clinical practice at multiple centers. Secondary objectives include overall safety assessment as well as description of diagnostic accuracy of the robotassisted bronchoscopy procedure.
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A Study To Detect Minimally-Invasive Barrett's Esophagus And Barrett's Esophagus Related Dysplasia/Carcinoma
Scottsdale/Phoenix, AZ; Austin, MN; Jacksonville, FL; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate if the capsule sponge device can detect the presence of Barrett's Esophagus.
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YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or ...
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A Global, Randomized, Placebo-controlled Phase 3 Study Of Fruquintinib In Patients With Refractory Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately 687 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
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Advancing Skin Cancer Prevention And Treatment Through DNA Repair Enzymes: A Clinical Approach In Solid Organ Transplant Recipients
Jacksonville, FL
The purpose of this study is to determine whether the application of topical DNA repair enzymes results in a statistically significant reduction in facial photodamage compared to sunscreen alone in solid organ transplant recipients (SOTRs).
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Radiation Therapy With Or Without Temozolomide In Treating Patients With Low-Grade Glioma
Jacksonville, FL; Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.
PURPOSE: This randomized phase III trial is studying radiation therapy ...
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A Study To Evaluate The Impact On Metastases-free Survival With The Addition Of Saruparib Versus Placebo To A Standard Radiotherapy/androgen Deprivation Regimen In Men With High-risk Prostate Cancer With A BRCA Mutation.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to evaluate the impact on metastases-free survival with the addition of saruparib versus placebo to a standard RT + ADT regimen in men with high-risk and very high-risk (localised/locally advanced) prostate cancer with a BRCAm.
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Tools To Evaluate Treatment Tolerability In Older Patients With Sarcoma
Rochester, MN
Sarcomas are rare, encompass multiple subtypes, and have few established guidelines. Geriatric assessments and screening tools are recommended as part of multi-disciplinary care for older patients with cancer, but they are not widely used in clinical practice. This pilot study will prospectively evaluate older patients (age 65 years and above) with sarcoma who are followed in the medical oncology sarcoma clinic in Rochester MN; this will include patients who are newly diagnosed or receiving systemic therapy. Patients will undergo geriatric screening as well as laboratory testing. Laboratory testing will include routine complete blood counts (CBC) that are associated ...
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A Study To Evaluate Hemorrhage And Thrombosis In Hematology Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to determine: the incidence of hemorrhage in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia, and recurrent or progressive venous thromboembolism in the 3 months following deep vein thrombosis diagnosis in hospitalized malignant hematology patients, based on anticoagulant use and presence of thrombocytopenia.
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Biorepository For Acute Leukemia Research
Rochester, MN
The purpose of this IRB protocol is to establish a specimen bank for research into acute leukemias. In particular, we plan to bank blood and bone marrow from patients with newly diagnoses or relapsed acute leukemia (AML or ALL) for future biological studies. By accruing samples both at initial diagnosis and at relapse, we will be able to investigate not only the biology of these marrow disorders, but also the changes that occur to render these disorders resistant to therapy. These activities are a first step toward identifying alternative therapies and subsequently beginning to personalize the therapy for these disorders.
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Study Of Safety And Efficacy Of Iberdomide (CC-220) And CC-99282 Combined With R-CHOP To Treat Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of Part 1 of this study is to define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-220 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone given in 21-day treatment cycles (R-CHOP-21) and CC99282 in combination with R-CHOP-21 in subjects with previously untreated, high risk (International Prognostic Index [IPI] 3 to 5), a-BCL.
The primary objective of Part 2 of this study is to further evaluate the safety and tolerability associated with CC-220 and CC-99282 at the RP2D in combination with R-CHOP-21 in subjects with previously untreated, high-risk (IPI 3 to 5), a-BCL.
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Changes In Blood Components In Patients With Ovarian Cancer
Rochester, MN
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
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Anesthesia And Non-small Cell Lung Cancer Recurrence
Jacksonville, FL
There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.
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A Study Of APR-246 And Pembrolizumab In Patients With Solid Tumor Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
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Combination Of Serabelisib And Insulin Suppressing Diet In Subjects With Advanced Solid Tumors With PIK3CA Mutations
Rochester, MN
The purpose of this study is to evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.
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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Rochester, MN
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody In Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of ZB131 in patients with solid tumors where prevalence of CSP expression is high.
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A Study To Compare Trilaciclib Versus Placebo In Patients Receiving FOLFOXIRI/Bevacizumab For Metastatic Colorectal Cancer
Rochester, MN
This study aims to evaluate the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.
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A Study Of RP2 With Nivolumab Compared To Ipilimumab With Nivolumab With Metastatic Uveal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall survival (OS) and to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on progression free survival (PFS).
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Panitumumab, Regorafenib, Or TAS-102, In Treating Patients With Metastatic And/or Unresectable RAS Wild-Type Colorectal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is: negative for RAS wild-type colorectal cancer and has spread to other places in the body, and/or cannot be removed by surgery, and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the ...
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Study Of Onvansertib In Combination With FOLFIRI And Bevacizumab Versus FOLFIRI And Bevacizumab For Second Line Treatment Of Metastatic Colorectal Cancer In Participants With A Kirsten Rat Sarcoma Virus Gene (KRAS) Or Neuroblastoma-RAS (NRAS) Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness of 2 different doses of onvansertib in combination with FOLFIRI and bevacizumab for the treatment of confirmed metastatic and/or unresectable CRC in patients with a KRAS or NRAS mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
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Study Of CPI-0610 In Myelofibrosis (MF)
Jacksonville, FL
This study aims to determine the efficacy of CPI-0610 + ruxolitinib compared with placebo + ruxolitinibin patients with naive myelofibrosis (MF).
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Pemigatinib To Treat Metastatic Or Unresectable Colorectal Cancer Harboring FGFR Alterations
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess how well Pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.
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A Study Of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) In Postmenopausal Women With Breast Cancer
Rochester, MN
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
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Maintain Respiratory Muscle Function And Reduce Pneumonia Risk In Cancer Patients
Rochester, MN
This research is intended to begin to explore the impact of inspiratory muscle resistance exercise and/or 1,25(OH)2D3 for improving respiratory muscle strength in cancer patients (subjects).
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A Dose Escalation And Confirmation Study Of PT-112 In Advanced Solid Tumors In Combination With Avelumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as ...
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A Study Of Intravital Microscopy (IVM) In Human Solid Tumors
Jacksonville, FL
The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.
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Diagnosing Lymphangioleiomyomatosis from Glycoprotein Non-Metastatic Melanoma Protein B
Rochester, MN
The purpose of this study is to analyze if levels of glycoprotein non-metastatic melanoma protein B be elevated in patients with LAM..
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Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
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Ultrasound-guided Tissue Acquisition Of Hepatic Draining Lymph Nodes In The Evaluation Of Unresectable Perihilar Cholangiocarcinoma
Jacksonville, FL
The purpose of this study is to test the feasibility of NanoString digital spatial profiling (DSP) and RNAscope™ on prospectively acquired HDLN tissue samples with EUS-FNB in patients with unresectable perihilar CCA undergoing liver transplant (LT) evaluation.
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A Study To Evaluate Trifluridine/Tipiracil In Combination With Irinotecan To Treat Biliary Tract Cancers
Rochester, MN
The purpose of this study is assess the effectiveness of trifluridine/tipiracil plus irinotecan in treating advanced, refractory biliary tract cancers (BTCs).
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Patient Self-sampling Of HPV To Screen For Cervical Cancer
Rochester, MN
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.
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A Study Of AMG 757 In Participants With Neuroendocrine Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and tolerability of AMG 757, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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A Study Of RLY-4008 In Patients With Intrahepatic Cholangiocarcinoma And Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to define the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D), safety profile, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of RLY-4008 in patients with ICC and other advanced solid tumors.
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Phase I Study Of [177Lu]Lu-NNS309 In Patients With Pancreatic, Lung, Breast And Colorectal Cancers
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).
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A Study To Assess Clonal Diversity Of Freshly Taken ESD Specimens
Rochester, MN
Inclusion Criteria:
- Patients with Barrett’s Esophagus (BE) or Esophageal Adenocarcinoma (EAC) that are planned for Endoscopic Submucosal Dissection (ESD) treatment.
Exclusion Criteria:
- Patients without BE or EAC or that are not planned for ESD treatment.
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Parotidectomy QOL Score
Rochester, MN
The objectives of this study are to explore the quality of life value of various surgical and functional outcomes after parotidectomy from a patient-centered perspective, develop a comprehensive patient-centered outcome measure after parotidectomy using a patient survey, and to validate the content of the above survey.
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Evaluating Markers Which Might Be A Predictor Of Pancreatic Cancer Or Precancer By Analyzing The Secretions (Fluid) From A Pancreatic Cyst
Rochester, MN
The purpose of this study is to evaluate molecular markers which might be a predictor of pancreatic cancer or precancer by analyzing the secretions (fluid) from a pancreatic cyst, pancreas fluid and tissue from a resected pancreatic cyst.
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Evaluating The Addition Of The Immunotherapy Drug Atezolizumab To Standard Chemotherapy Treatment For Advanced Or Metastatic Neuroendocrine Carcinomas That Originate Outside The Lung
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
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Endoscopic Radiofrequency Ablation Induced Tumor Microenvironment Remodeling In Cholangiocarcinoma
Rochester, MN
The objective of the study is to study the systemic immunological effects of Radiofrequency Ablation in patients with advanced Extrahepatic cholangiocarcinoma.
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A Study To Evaluate Tucatinib Plus Trastuzumab And Oxaliplatin-based Chemotherapy For HER2+ Gastrointestinal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the recommended dose of tucatinib when combined with trastuzumab and modified FOLFOX7 (mFOLFOX7) or CAPOX in subjects with human epidermal growth factor receptor 2 (HER2)+ gastrointestinal cancers.
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Combination Of Serabelisib And Insulin Suppressing Diet In Subjects With Advanced Solid Tumors With PIK3CA Mutations
Rochester, MN
The purpose of this study is to evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an Insulin Suppressing Diet (ISD) with a goal of reducing side effects and enhancing anticancer activity.
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Z-Endoxifen Hydrochloride in Treating Patients with Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.
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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
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Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients with Refractory or Relapsed Neuroblastoma
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them ...
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Rochester, MN
This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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DNA Damage Using HERY-MNT Technology Can Predict Chemotherapy Induced Toxicity In Women With Ovarian Cancer
Rochester, MN
The purpose of this study is to understand changes that take place in the blood of patients with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. This portion of the study is to understand the changes that occur in your blood during and after treatment with carboplatin and paclitaxel chemotherapy in women with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
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MV-NIS Or Investigator's Choice Chemotherapy In Treating Patients With Ovarian, Fallopian, Or Peritoneal Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.
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A Study Of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared To Pembrolizumab Alone In People With Previously Untreated Metastatic Colorectal Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...
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Understanding Treatment Preferences In Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this research is to understand how people with lymphoma make decisions about treatment and why. Study participation involves partaking in one virtual focus group session with a group of up to 8 people with lymphoma and up to two group moderators. Participants will be asked questions about what they prefer in a lymphoma treatment and how they have made decisions on treatment of their lymphoma in the past. Questions may be about past experiences as well as future hypothetical situations. We hope that what we learn from these discussions will help us to improve care for people ...
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Genetic Analysis In Blood And Tumor Samples From Patients With Advanced Or Metastatic Estrogen Receptor Positive And HER2 Negative Breast Cancer Receiving Palbociclib And Endocrine Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and endocrine therapy. Examine the genetic changes associated with the cancer and comparing the genetic material from the cancer tissue with the genetic material found in the blood may help doctors to develop customized treatment for breast cancer.
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Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer
Rochester, MN
This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. - Paclitaxel (also called Taxol) - Doxorubicin also called Adriamycin - Cyclophosphamide, also called Cytoxan
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Simplified Patient Care Strategy In Decreasing Early Death In Patients With Acute Promyelocytic Leukemia
Jacksonville, FL; Rochester, MN
This clinical trial studies how well simplified patient care strategy works in decreasing early death in patients with acute promyelocytic leukemia. Implementing simplified acute promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival.
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Ga-DOTATATE PET For Localization Of Phosphaturic Mesenchymal Tumors In Patients With Tumor Induced Osteomalacia
Rochester, MN
This study aims to identify cases of FGF23-mediated oncogenic osteoomalacia in which the underlying phosphaturic mesenchymal has not been found and perform 68Ga-DOTATATE PET in these patients to localize the tumor.
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A Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Fruquintinib In Patients With Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The study is an open-label, dose escalation clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors.
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Reishi Mushroom Extract For Fatigue And/or Arthralgias/Myalgias In Patients With Breast Cancer On Aromatase Inhibitors
Albert Lea, MN; Mankato, MN; Rochester, MN
This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and ...
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Highly Selective CDK7 Inhibitor Q901 In Selected Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter.
The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, ...
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A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives for this study are:
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
Percentage of screened subjects experiencing loss ...
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Panchromoendoscopy using Oral Indigo Carmine Mixed with Polyethylene Glycol Prep
Scottsdale/Phoenix, AZ
This study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. It then will use this adequate staining concentration of Indigo Carmine to study whether this dye will increase the detection of polyps during colonoscopy.
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A Clinical Use Application for the Humanitarian Use Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Primary or Secondary Liver Neoplasia
Eau Claire, WI
This protocol allows multiple treatments with TheraSphere® that may be delivered on an outpatient basis. Patients may receive a single dose to a liver lobe or segmental treatment delivered as a sequence of treatments approximately 30-90 days apart. The principal clinician, working with a multidisciplinary team, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy and the desired goal of treatment.
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A Study to Evaluate the Awareness and Acceptability of Primary HPV Testing and Self Collection for Cervical Cancer in Patients and Primary Care Physicians
Rochester, MN
The purposes of this study are to assess awareness and acceptability of HPV testing for cervical cancer screening and patient self-collection of vaginal swabs among women aged 30 to 65 years old, to assess awareness and acceptability of HPV testing for cervical cancer screening and patient self-collection of vaginal swabs among primary care clinicians, and to identify insights from regional and national thought leaders in the fields of primary care and cervical cancer screening on strategies to improve uptake of primary HPV screening and opinions on patient self-collection by conducting key informant interviews.
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The Microenvironment In Barrett's Esophagus
Austin, MN; Rochester, MN
This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA ...
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A Study Of ABC294640 (Yeliva®) In The Treatment Of Patients With Advanced Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®) in the treatment of cholangiocarcinoma (CCA). In this clinical study, all participants will be receiving ABC294640. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. In this study, ABC294640 will be ...
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A Study To Compare Colon Lavage Fluids For Pancreatic Cancer Marker Validation
Jacksonville, FL
The purpose of this study is to compare the proteomic markers from gastrointestinal lavage fluid collected from patients with a pancreatic mass to a control group of otherwise healthy subjects.
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Gemini Study To Evaluate The Integration Of Cancer Genetic Testing Into A Cancer Clinical Practice At Mayo Clinic At Arizona
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.
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A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
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A Study To Evaluate MM-151, Nal-IRI, 5-FU, And Leucovorin For RAS/RAF Wild-Type Metastatic Colorectal Cancer
Jacksonville, FL
The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151, nal-IRI, 5-FU, and leucovorin for the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.
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A Study To Evaluate MM-151, Nal-IRI, 5-FU, And Leucovorin For RAS/RAF Wild-Type Metastatic Colorectal Cancer
Jacksonville, FL
The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151, nal-IRI, 5-FU, and leucovorin for the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.
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A Study Of Elacestrant Versus Standard Endocrine Therapy In Women And Men With ER+,HER2-, Early Breast Cancer With High Risk Of Recurrence
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
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A Study Of SGN-B7H4V In Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...
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Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of AG-270 and characterize its dose-limiting toxicities (DLTs) when given daily by mouth to subjects with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).
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Trial Of 225Ac-DOTATATE (RYZ101) Alone And With Pembrolizumab In Subjects With ER+, HER2-negative Unresectable Or Metastatic Breast Cancer Expressing SSTRs (TRACY-1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended phase 2 dose (RP2D), the optimal treatment regimen and to evaluate preliminary efficacy of RYZ101 in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally advanced and unresectable or metastatic breast cancer.
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A Study Of Intratumoral Injection Of Autologous Dendritic Cells After High-Dose Conformal External Beam Radiotherapy In Patients With Unresectable Liver Cancer
Rochester, MN
The primary purpose of the pilot study is to evaluate the safety and tolerability of an autologous dendritic cells (DC) vaccine delivered by intra-tumoral injection in patients with primary liver cancer treated with high-dose conformal external beam radiotherapy (EBRT).
The primary purpose of the phase II study is to estimate the progression-free survival rate at 2 years post-registration to see if treatment is efficacious compared to historical data.
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XmAb®20717 Alone Or In Combination With Chemotherapy Or Targeted Therapy In Patients With Metastatic Castration-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety and clinical activity of XmAb20717 alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with at least 2 prior lines of anticancer therapy.
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Study Of DS-1062a In Advanced Or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, pharmacokinetics (PK), and safety of DS-1062a in subjects with advanced or metastatic NSCLC with known actionable genomic alterations (i.e., alterations in genes with approved therapies, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, and RET) and that has progressed on or after 1 or more kinase inhibitors and platinum-based chemotherapy.
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Understanding Financial Toxicity In Management Of Advanced Prostate Cancer From Qualitative Approach
Rochester, MN
The purpose of this study is to identify characteristics of financial toxicity unique to advanced prostate cancer, especially those areas not assessed through current objective measures, and describe how can these areas inform potential interventions to ameliorate financial toxicity.
This aim will be accomplished through qualitative focus group study of advanced prostate cancer patients who exhibit both extremes of financial toxicity. Findings will be presented in a joint display with quantitative survey data obtained in a prior study.
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A Study To Evaluate Screening Biomarkers For Lung Cancer
Jacksonville, FL
The purpose of this study is to evaluate new and complementary analytical MS technologies to identify and define the metabolic biomarkers for lung cancer.
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A Study To Compare Durvalumab Vs Placebo Following Stereotactic Body Radiation Therapy In Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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A Study Of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy For Advanced Non-Small Cell Lung Cancer (MK-3475-495)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with ...
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A Study Of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab In Participants With Non-small Cell Lung Cancer (V940-002)
Jacksonville, FL
The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
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Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
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Establishing A Possible Correlation Between Chest Wall And Breast Lymphedema
Rochester, MN
The purpose of this study is to address current gaps in research by further establishing a possible correlation between chest wall and breast lymphedema, as measured by the Delfin Moisture Meter D Compact, to a decreased quality of life (LymQOL-midline questionnaire) as well as decreased shoulder function (DASH questionnaire).
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A Study To Evaluate Precision Pharmacogenomics In Cancer Patients
Scottsdale/Phoenix, AZ
THe purpose of this study is to examine the current and (potential) future therapeutic relevance of pharmacogenomics (PGx) testing for a cohort of cancer patients in order to improve quality of life (QOL) in patients receiving clinical care at Mayo Clinic.
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Study Of TBio-6517, Given Intratumorally, Alone Or In Combination With Pembrolizumab, In Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
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MicroOrganoSphere Drug Screen Pilot Trial In Colorectal Cancer (CRC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14="">
The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.
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A Phase I/II, Open-label, Multi-center Trial Of [177Lu]Lu-NeoB In Combination With Capecitabine In Adult Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression On Previous Endocrine Therapy In Combination With A CDK4/6 Inhibito
Rochester, MN
The purpose of this study is to determine the recommended doses (RD) and dosing regimens of [ 177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary antitumor activity of two different doses/regimens of [177Lu]Lu-NeoB in combination with capecitabine (dose optimization).
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Taletrectinib Phase 2 Global Study In ROS1 Positive NSCLC
Rochester, MN
The main purpose of the study is to evaluate safety and effectiveness of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
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Sacituzumab Tirumotecan (MK-2870) In Combination With Pembrolizumab Versus Pembrolizumab Alone In Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
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Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy For Salvage Of Biochemically Recurrent Or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine if salvage stereotactic body radiotherapy (SBRT) is non-inferior to moderately hypofractionated radiation therapy (HFRT) regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) Grade 3 or higher within 2-years.
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International Registry For Men With Advanced Prostate Cancer (IRONMAN)
Jacksonville, FL
The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.
The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.
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An Adjuvant Study To Evaluate SMS001 (Paclitaxel) In Non-Small Cell Lung Cancer
Rochester, MN
This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.
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A Study To Evaluate Telisotuzumab Vedotin (ABBV-399) In Subjects With Previously Treated C-Met+ Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpse of this study is to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for Telisotuzumab Vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate effectiveness in the selected population(s) (Stage 2).
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Early Integrated Telehealth Versus In-Person Palliative Care For Patients With Lung Cancer
Rochester, MN
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.
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Randomized Trial Of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) For The Treatment Of Oropharyngeal Cancer Of The Head And Neck
Scottsdale/Phoenix, AZ; Rochester, MN
The overall goal of this trial is to identify a less toxic approach to the delivery of conformal radiation therapy for patients with cancers of the oropharynx.
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Phase I/II Study Of [225Ac]Ac-PSMA-R2 In PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
Rochester, MN
This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.
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A Study Of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody In Participants With Advanced Or Metastatic NSCLC
Rochester, MN
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
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Avelumab With Binimetinib, Sacituzumab Govitecan, Or Liposomal Doxorubicin In Treating Patients With Stage IV Or Unresectable, Recurrent Triple Negative Breast Cancer
Rochester, MN
The purpose of this study is to evaluate how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent).
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Ablation With Confirmation Of Colorectal Liver Metastases (ACCLAIM)
Rochester, MN
The purpose of this study is to demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.
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Understanding The Challenges, Behavioral Patterns, And Preferences Towards Participation In Clinical Trials In Minority Patient Populations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.
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A Study to Evaluate Brain Natriuretic Peptides for the Avoidance of Treatment-Related Heart Failure in Breast Cancer Survivors
Rochester, MN
The purpose of this study is to determine if Brain Natriuretic Peptide (NT-pro-BNP) values increase over time in breast cancer survivors and correlate with cardiac dysfunction. This study will define the average NT-pro-B-natriuretic peptide values in female breast cancer patients 1, 2, 3, 4, and 5 years out from anthracycline-based chemotherapy.
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A Study To Evaluate Docetaxel With Or Without Bintrafusp Alfa To Treat Patients With Advanced Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) of docetaxel in combination with bintrafusp alfa vs. docetaxel alone.
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A Study Of Poziotinib In Patients With NSCLC With EGFR Or HER2 Exon 20 Insertion Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the efficacy and the safety/tolerability of poziotinib in patients with NSCLC exon 20 insertion mutations.
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A Study To Evaluate Gevokizumab With Standard Of Care Anti-cancer Therapies For Metastatic Colorectal, Gastroesophageal, And Renal Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose and preliminary effectiveness of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma.
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A Blood Collection Protocol To Study The Immune Responses Of Cancer Patients With Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic ...
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Biospecimen Resource for Hepatocellular Carcinoma Research
Jacksonville, FL
The purpose of this study is to create a registry of patients with liver cancer (also known as hepatocellular carcinoma) and individuals with no history of liver cancer in order to characterize risk factors for liver cancer and identify biomarkers for early detection of liver cancer.
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A Study to Evaluate S-Adenosyl-L-Methionine for the Treatment of Hot Flashes
Rochester, MN
The purpose of this study is to assess the side effects and effectiveness of s-adenosyl-L-methionine for treating hot flashes in women who have a history of breast cancer or who do not wish to take estrogen due to a perceived increased risk of breast cancer.
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Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL
Jacksonville, FL
The purpose of this study is to evaluate GDA-201, an allogeneic cryopreserved NK cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).
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18F-fluciclovine PET/MRI Imaging For The Detection Of Tumor Recurrence After Radiation Injury To The Brain
Jacksonville, FL
The goal of this study is to further evaluate the ability of fluciclovine PET to discriminate between radiation necrosis and tumor progression in patients with previously irradiated intracranial metastatic disease.
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AB-2100, An Integrated Circuit T (ICT) Cell Therapy In Patients With Recurrent Clear-cell Renal Cell Carcinoma (CcRCC)
Scottsdale/Phoenix, AZ
This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.
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Phase 3 Study Of Taletrectinib Vs Placebo As An Adjuvant Therapy In ROS1 Positive NSCLC (TRUST-IV)
Rochester, MN
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
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Phase III Study Of Datopotamab Deruxtecan Versus Docetaxel In Previously Treated TROP2-positive Advanced Or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Eau Claire, WI; Jacksonville, FL; Rochester, MN
TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).
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A Study Of Nivolumab And Multi-fraction Stereotactic Radiosurgery With Or Without Ipilimumab In Treating Participants With Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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A Study Of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Rochester, MN
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
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Circulating Tumor Nucleic Acids To Monitor Treatment Response In Metastatic Melanoma Patients
Scottsdale/Phoenix, AZ
This project will investigate whether the analysis of nucleic acids circulating in the blood from tumors can allow real-time monitoring of treatment response to targeted therapy and immunotherapy for patients who have stage IV metastatic melanoma.
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A Study Of JNJ-90009530 In Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma (R/r B-NHL)
Rochester, MN
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: -can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
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Phase 3 Trial Of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment Of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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JSI-1187-01 Monotherapy And In Combination With Dabrafenib For Advanced Solid Tumors With MAPK Pathway Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
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Pertuzumab, Trastuzumab, Hyaluronidase-zzxf And Enzalutamide For The Treatment Of Metastatic Castration-Resistant Prostate Cancer, TraPPer Study
Rochester, MN
This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an ...
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A Study Of Patients Undergoing Neoadjuvant Therapy For Resectable Non-small Cell Lung Cancer To Evaluate Perioperative Circulating Tumor DNA As A Prognostic Biomarker
Jacksonville, FL
The purpose of this study is to determine the validity of employing quantitative ctDNA as a surrogate marker for pathologic treatment response in patients receiving neoadjuvant therapy for Stage IIA-IIIB NSCLC undergoing curative-intent resection. We will assess the relationship between major pathologic response (≤10% viable tumor remaining) and percent change in levels of ctDNA concentration before and after neoadjuvant therapy.
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A Study To Evaluate Firstline Pembrolizumab Alone Or In Combination With Pemetrexed And Carboplatin In Induction/Maintenance Or Postprogression In Treating Patients With Stage IV Non-squamous Non-small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of ...
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Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy Or Plus Camizestrant In HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, Or PALB2m Advanced Breast Cancer
Jacksonville, FL; Rochester, MN
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer.
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A Study Of BH-30643 In Subjects With Locally Advanced Or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.
Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.
Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the ...
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A Tool For Improving The Shared Decision-making Process In Patients With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to use the shared decision-making (SDM) tool in clinical conversations to test whether these SDM tools affect patient understanding, treatment fidelity, or outcomes in patients with lung cancer.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Non-squamous NSCLC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
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Neoadjuvant Dual Checkpoint Blockade With PD1 And LAG-3 Inhibition In Resectable Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is toassess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 1-49%, as measured by rate of major pathologic response (MPR) (defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. To assess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 ≥50%, as measured by rate of major pathologic response (MPR).
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Radiation Therapy With Or Without Apalutamide In Treating Patients With Stage III-IV Prostate Cancer
Albert Lea, MN
The purpose of this study is to determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation therapy (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
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A Study Of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) In Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel In Participants With Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)
Scottsdale/Phoenix, AZ
This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).
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Clinical Study Of Oral CMET Inhibitor INC280 In Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer
Rochester, MN
A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
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A Study Of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy In Patients With Resectable Stage II, IIIA, Or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
Rochester, MN
This is a randomized, double-blinded study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.
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Study Of Retinfanlimab In Combination With INCAGN02385 And INCAGN02390 As First-Line Treatment In Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma Of The Head And Neck
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
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A Study of Women undergoing Mammogram Screening at Mountain Park Clinic
Scottsdale/Phoenix, AZ; Rochester, MN
The goal of this research is to identify risk profiles of women (with particular emphasis on Hispanic women) for breast cancer based on family history, breast density and other factors known to impact risk such as age, weight, age at menarche, age at birth of first child, etc.
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A.I. Software Evaluation and Development for Breast Cancer Detection in Tomosynthesis Scans
Rochester, MN
The goal of this project is to develop an AI system for early cancer detection on routine screening tomosynthesis mammograms. There will be significant impact on clinical practices if a mammography AI tool can be built. Such a tool will improve efficiency and decrease false positives and false negatives in practice.
This protocol captures the details for the reader study involving Aidoc, ScreenPoint, and iCAD. Mayo Clinic Breast Imaging Radiologists will evaluate the software tools that both ScreenPoint and iCAD have developed for assisting in reading tomosynthesis scans. Aidoc is facilitating this study by providing their user ...
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Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.
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Study Of Vorasidenib (AG-881) In Participants With Residual Or Recurrent Grade 2 Glioma With An IDH1 Or IDH2 Mutation (INDIGO)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization.
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Lung Nodule Management And Lung Cancer Screening In Patients With Abnormal Ct-Scan
Jacksonville, FL
The purpose of this study is to assess the current rate of adherence to incidental lung nodule management and lung cancer screening guidelines in at-risk lung cancer patients identified from chart review.
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A Phase IV Post Approval Clinical Study Of ExAblate Treatment Of Metastatic Bone Tumors For The Palliation Of Pain
Rochester, MN
The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.
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A Study To Evaluate 68Ga- PSMA-Dual Contrast PET/MRI And PET/CT For Hepatocellular Carcinoma
Rochester, MN
The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.
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A Study To Evaluate Regulation Of The Metabolism Of T-Cells By The Tumor Microenvironment In Ovarian Cancer Metastasis
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze how the immune cell repertoire changes during early and late metastasis which could shed light into how the tumor microenvironment in metastatic disease becomes tumor permissive.
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Recognition By Metabolomic Analysis Of Serum Of Hepatocellular Carcinoma
Rochester, MN
The purpose of this study is to validate an NMR-based (Nuclear magnetic resonance) serum metabolite constellation for detection of early Hepatocellular carcinoma (HCC) lesions in liver cirrhosis.
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A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab And A Combined Regimen Of Mosunetuzumab And Venetoclax In Participants With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Rochester, MN
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) ...
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A Study Evaluating Atezolizumab And Bevacizumab, With Or Without Tiragolumab, In Participants With Untreated Locally Advanced Or Metastatic Hepatocellular Carcinoma (IMbrave152) (SKYSCRAPER-14)
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
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A Study Of CA-4948 In Patients With Relapsed Or Refractory Primary Central Nervous System Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.
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MEDI5752 In Combination With Carboplatin Plus Pemetrexed In Unresectable Pleural Mesothelioma
Jacksonville, FL; Rochester, MN
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.
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XmAb®20717 Alone Or In Combination With Chemotherapy Or Targeted Therapy In Patients With Metastatic Castration-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety and clinical activity of XmAb20717 alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with at least 2 prior lines of anticancer therapy.
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Study Of DS-1062a In Advanced Or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, pharmacokinetics (PK), and safety of DS-1062a in subjects with advanced or metastatic NSCLC with known actionable genomic alterations (i.e., alterations in genes with approved therapies, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, and RET) and that has progressed on or after 1 or more kinase inhibitors and platinum-based chemotherapy.
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A Study Of Intratumoral Injection Of Autologous Dendritic Cells After High-Dose Conformal External Beam Radiotherapy In Patients With Unresectable Liver Cancer
Rochester, MN
The primary purpose of the pilot study is to evaluate the safety and tolerability of an autologous dendritic cells (DC) vaccine delivered by intra-tumoral injection in patients with primary liver cancer treated with high-dose conformal external beam radiotherapy (EBRT).
The primary purpose of the phase II study is to estimate the progression-free survival rate at 2 years post-registration to see if treatment is efficacious compared to historical data.
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A Study To Compare Durvalumab Vs Placebo Following Stereotactic Body Radiation Therapy In Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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Understanding Financial Toxicity In Management Of Advanced Prostate Cancer From Qualitative Approach
Rochester, MN
The purpose of this study is to identify characteristics of financial toxicity unique to advanced prostate cancer, especially those areas not assessed through current objective measures, and describe how can these areas inform potential interventions to ameliorate financial toxicity.
This aim will be accomplished through qualitative focus group study of advanced prostate cancer patients who exhibit both extremes of financial toxicity. Findings will be presented in a joint display with quantitative survey data obtained in a prior study.
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A Study To Evaluate Screening Biomarkers For Lung Cancer
Jacksonville, FL
The purpose of this study is to evaluate new and complementary analytical MS technologies to identify and define the metabolic biomarkers for lung cancer.
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A Study Of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab In Participants With Non-small Cell Lung Cancer (V940-002)
Jacksonville, FL
The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
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Evaluating The Addition Of Adjuvant Chemotherapy To Ovarian Function Suppression Plus Endocrine Therapy In Premenopausal Patients With PN0-1, ER-Positive/HER2-Negative Breast Cancer And An Oncotype Recurrence Score Less Than Or Equal To 25
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
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Establishing A Possible Correlation Between Chest Wall And Breast Lymphedema
Rochester, MN
The purpose of this study is to address current gaps in research by further establishing a possible correlation between chest wall and breast lymphedema, as measured by the Delfin Moisture Meter D Compact, to a decreased quality of life (LymQOL-midline questionnaire) as well as decreased shoulder function (DASH questionnaire).
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A Study Of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy For Advanced Non-Small Cell Lung Cancer (MK-3475-495)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with ...
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Determining the Special Gene Expressions in Patients with Lung Cancer or Mesothelioma
Rochester, MN
This study is being done to evaluate the immune system in patients with lung cancer or mesothelioma. We are going to analyze which genes are expressed by cells that fight infections to see if there are any relations to cancer.
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A Study of the Safety and Effectiveness of Nivolumab for the Treatment of Advanced Non-Small Cell Lung Cancer
Jacksonville, FL
The purpose of this study is to determine whether nivolumab alone or in combination with standard of care therapies will provide clinical benefit without unacceptable toxicity for the treatment of advanced non-small cell lung cancer patients.
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A Platform Study In Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
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A Study To Evaluate The Effect Of Canakinumab Or Pembrolizumab Given As Monotherapy Or In Combination As Neo-adjuvant Treatment For Subjects With Early Stages NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effect of canakinumab or pembrolizumab as monotherapy or combined as neo-adjuvant treatment for subjects with early stage non-small cell lung cancer.
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A Study Of Radiation Dosimetry, Safety, And Tolerability Of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment In Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
Rochester, MN
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
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Atezolizumab Immunotherapy In Patients With Advanced NSCLC (AJCC 7th Edition)
Scottsdale/Phoenix, AZ
Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable stage IIIA and IIIB NSCLC (AJCC 7th Edition) eligible for chemoradiotherapy with curative intent.
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JAB-3312 Based Combination Therapy In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.
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A Study To Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy For Locally-advanced Bulky Tumors
Jacksonville, FL; Rochester, MN
The purpose of this research is to study radiographic control at the 3 month time-point, the side effects (good & bad), survival outcomes and proof of this idea in patients who have had grid therapy for locally advanced bulky tumors of the heat and neck, thorax, abdomen and extremities.
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Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy In Early-Stage Resectable NSCLC (VIGOR)
Rochester, MN
The purpose of this study is to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with non-small cell lung cancer (NSCLC) who may be candidates for resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.
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Effectiveness And Safety Of Pembrolizumab For Participants With Resectable Stage IIB Or IIIA Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
This trial will evaluate the safety and effectiveness of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).
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A Study To Evaluate Durvalumab Alone Or In Combination With Novel Agents In Subjects With NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
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Role of Eicosanoids in Intestinal Biology
Scottsdale/Phoenix, AZ
The purpose of this study is to see how the DNA methylation (a biochemical process involved in cell development) is activated during initial tumor growth and tumor progression. In order to look at this in patients with colorectal cancer or adenoma we must look at their tissue collected during surgery. Fresh tissue is required in order to study the primary cells in culture.
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A Study of the Ability to Predict Lymphedema Development Following Axillary Surgery for Breast Cancer and Its Effects on Patient Survivorship
Jacksonville, FL
The purpose of this study is to better understand the anatomy of the lymphatic structure and the molecular process that leads to the over production of lymph fluid. This proposal will begin intense lymphedema screening and identify baseline characteristics potentially predisposing someone to lymphedema, and identify molecular markers that might be altered to prevent lymphedema.
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5-strain Probiotic Formulation in Hormone Receptor-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
Jacksonville, FL
The purpose of this is a prospective, pilot, single-arm study to evaluate the median percent change in C-terminal telopeptide of type 1 collagen (CTx) after WBF-038 in early-stage breast cancer patients receiving aromatase inhibitors after 3- and 12-month treatment.
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A Study to Evaluate Brain Natriuretic Peptides for the Avoidance of Treatment-Related Heart Failure in Breast Cancer Survivors
Rochester, MN
The purpose of this study is to determine if Brain Natriuretic Peptide (NT-pro-BNP) values increase over time in breast cancer survivors and correlate with cardiac dysfunction. This study will define the average NT-pro-B-natriuretic peptide values in female breast cancer patients 1, 2, 3, 4, and 5 years out from anthracycline-based chemotherapy.
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A Study To Evaluate Docetaxel With Or Without Bintrafusp Alfa To Treat Patients With Advanced Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) of docetaxel in combination with bintrafusp alfa vs. docetaxel alone.
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A Study Of Poziotinib In Patients With NSCLC With EGFR Or HER2 Exon 20 Insertion Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the efficacy and the safety/tolerability of poziotinib in patients with NSCLC exon 20 insertion mutations.
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Study Of Retinfanlimab In Combination With INCAGN02385 And INCAGN02390 As First-Line Treatment In Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma Of The Head And Neck
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
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Study Of Cabozantinib Alone Or In Combination With Atezolizumab To Subjects With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), and non-small-cell lung cancer (NSCLC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established. In the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment ...
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A Study of Women undergoing Mammogram Screening at Mountain Park Clinic
Scottsdale/Phoenix, AZ; Rochester, MN
The goal of this research is to identify risk profiles of women (with particular emphasis on Hispanic women) for breast cancer based on family history, breast density and other factors known to impact risk such as age, weight, age at menarche, age at birth of first child, etc.
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A.I. Software Evaluation and Development for Breast Cancer Detection in Tomosynthesis Scans
Rochester, MN
The goal of this project is to develop an AI system for early cancer detection on routine screening tomosynthesis mammograms. There will be significant impact on clinical practices if a mammography AI tool can be built. Such a tool will improve efficiency and decrease false positives and false negatives in practice.
This protocol captures the details for the reader study involving Aidoc, ScreenPoint, and iCAD. Mayo Clinic Breast Imaging Radiologists will evaluate the software tools that both ScreenPoint and iCAD have developed for assisting in reading tomosynthesis scans. Aidoc is facilitating this study by providing their user ...
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Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.
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Lung Nodule Management And Lung Cancer Screening In Patients With Abnormal Ct-Scan
Jacksonville, FL
The purpose of this study is to assess the current rate of adherence to incidental lung nodule management and lung cancer screening guidelines in at-risk lung cancer patients identified from chart review.
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A Phase IV Post Approval Clinical Study Of ExAblate Treatment Of Metastatic Bone Tumors For The Palliation Of Pain
Rochester, MN
The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.
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Study Of Vorasidenib (AG-881) In Participants With Residual Or Recurrent Grade 2 Glioma With An IDH1 Or IDH2 Mutation (INDIGO)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization.
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A Study To Evaluate 68Ga- PSMA-Dual Contrast PET/MRI And PET/CT For Hepatocellular Carcinoma
Rochester, MN
The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.
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A Study To Evaluate Regulation Of The Metabolism Of T-Cells By The Tumor Microenvironment In Ovarian Cancer Metastasis
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze how the immune cell repertoire changes during early and late metastasis which could shed light into how the tumor microenvironment in metastatic disease becomes tumor permissive.
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Recognition By Metabolomic Analysis Of Serum Of Hepatocellular Carcinoma
Rochester, MN
The purpose of this study is to validate an NMR-based (Nuclear magnetic resonance) serum metabolite constellation for detection of early Hepatocellular carcinoma (HCC) lesions in liver cirrhosis.
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A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab And A Combined Regimen Of Mosunetuzumab And Venetoclax In Participants With Relapsed Or Refractory Chronic Lymphocytic Leukemia
Rochester, MN
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) ...
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A Study Evaluating Atezolizumab And Bevacizumab, With Or Without Tiragolumab, In Participants With Untreated Locally Advanced Or Metastatic Hepatocellular Carcinoma (IMbrave152) (SKYSCRAPER-14)
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
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A Study Of CA-4948 In Patients With Relapsed Or Refractory Primary Central Nervous System Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.
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MEDI5752 In Combination With Carboplatin Plus Pemetrexed In Unresectable Pleural Mesothelioma
Jacksonville, FL; Rochester, MN
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.
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Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.
Rochester, MN
The purpose of this study is to evaluating the clinical outcomes of grid therapy.
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Nivolumab In Treating Patients With Relapsed Or Refractory Peripheral T-cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
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A Feasibility Study To Evaluate The Safety Of The TheraSphere Glioblastoma (GBM) Device In Patients With Recurrent GBM
Jacksonville, FL
The purpose of this study is to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent glioblastoma (GBM).
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A Study To Find New Family Linked Forms Of Kidney Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to use the saliva of patients and relatives with known kidney cancer to look for unknown genes that may cause kidney cancer and are being passed down between family members
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A Study To Assess BMS-986458 Alone And In Combination With Anti-lymphoma Agents In Relapsed/Refractory Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader (LDD) of BCL6 (BCL6 LDD), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
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Ipilimumab And Nivolumab As Adjuvant Treatment Of Mucosal Melanoma
Rochester, MN
The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.
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Trial Of TRC105 And Sorafenib In Patients With HCC
Jacksonville, FL
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma. Up to 18 patients will be treated. The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.
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AUTO1 In Relapsed Or Refractory B-ALL
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of AUTO1 (t-cells) in adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia (r/r B-ALL).
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Study To Evaluate The Safety, Tolerability And Antitumor Activity Of Anti-B7-H3 Car-T Cell Injection (TX103) In Subjects With Recurrent Or Progressive Grade 4 Glioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of Anti-B7-H3 CAR-T Cell Injection administered via intraventricular [ICV] delivery or intracavitary [ICT]/ ICV dual delivery in subjects with recurrent or progressive grade 4 glioma. To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for intracranial infusion of Anti-B7-H3 CAR-T Cell Injection.
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TheraSphere With And Without Durvalumab And Tremelimumab For HCC
Jacksonville, FL
The objective of the ROWAN clinical study is to assess the the durability of local tumor control in Hepatocellular Carcinoma (HCC) patients who receive TheraSphere followed by durvalumab and tremelimumab, compared to those who receive TheraSphere treatment alone.
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Retifanlimab With Bevacizumab And Hypofractionated Radiotherapy For The Treatment Of Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class ...
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Expanded Access Program With Nivolumab (BMS-936558) In Combination With Ipilimumab (Yervoy®) In Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable Or Metastatic Melanoma (CheckMate 218)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to provide treatment with Nivolumab in combination with Ipilimumab and to assess the safety and tolerability of this combination in subjects who are anti-cytotoxic T lymphocyte associated antigen (CTLA)-4 treatment-naive and have unresectable or metastatic melanoma.
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Pilot Clinical Study To Evaluate Molecular Breast Imaging- Guidance For Sampling Of Breast Abnormalities In Patients With Known Or Suspected Breast Cancer
Rochester, MN
The purpose of this study is to confirm that the Stereo Navigator accessory to an MBI Imging system can successfully guide the sampling of abnormal MBI findings in patients with known or suspected breast cancer.
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A Trial To Evaluate Multiple Regimens In Newly Diagnosed And Recurrent Glioblastoma
Jacksonville, FL; Rochester, MN
The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
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A Study Of A Personalized Neoantigen Cancer Vaccine
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.
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Rare Cutaneous Tumors and Unresolved Issues with the Current AJCC Cutaneous Carcinoma Staging System
Rochester, MN
Our aim is to study non-melanoma skin cancers (NMSC), rare and adnexal tumor outcomes in the context of the current cutaneous AJCC staging system. We will also examine these rare tumors for other potentially significant factors.
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A Study To Quantify Microvasculature Imaging For Breast Cancer Detection And Monitoring
Rochester, MN
The purpose of this study is to apply new microvasculature imaging for differentiation of breast lesions, and prediction of response to preoperative chemotherapy.
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A Study To Evaluate Personalized Molecular Marker And Immunoprofiling To Transform Hepatocellular Carcinoma Treatment
Jacksonville, FL
The purpose of this study is to evaluate whether profiling aggressive tumors for molecular alterations, together with drug testing in patient-derived 3D models, can provide crucial information for the identification of specific therapeutic targets. Additionally, immunoprofiling of microcancer model systems is crucially necessary data to enable prediction of immunotherapeutic efficacy. We postulate that our innovative approach will establish much needed immune microenvironment information and facilitate the identification of specific sensitivity profiles and biomarker signatures that correlate response to targeted agents (or combinations) with particular tumor profiles.
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Circulating Tumor DNA In Endometrial Cancer
Rochester, MN
The goal of this study is to identify circulating tumor DNA in the preoperative blood samples of endometrial cancer patients and detect changes in the quantity and tumor-specific mutations and chromosomal rearrangements in circulating tumor DNA of patients with endometrial cancer.
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A Study To Identify Biomarkers In The Blood, Saliva Or Tissue For Oropharyngeal Squamous Cell Cancer
Rochester, MN
The purpose of this study is to identify a biomarker (or biomarkers) that is present when disease is present (i.e., at diagnosis or recurrence) and not present when disease is absent (i.e., after treatment, in HPV negative patients or in normal controls).
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A Study To Compare Conventional Heart Echo Measurements With Newer 2 And 3 Dimensional Measurements Of Mechanical Heart Strain After Trastuzumab Infusion
Rochester, MN
The purpose of this study is to compare conventional assessment of systolic ventricular function on a 2D heart echo with an assessment of more immediate changes in heart mechanics using 2D and 3D measurements of deformation and strain in patients undergoing infusion of Trastuzumab for breast cancer.
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A Study Of X4P-001 In Patients With Advanced Renal Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the study is to test different doses of X4P-001 given alone and in combination with axitinib in patients diagnosed with advanced renal cell carcinoma. The goals of the study are to determine the safety and tolerability of X4P-001, as well as the potential effect it may have on the body and the cancer tumor.
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177Lu-DTPA-Omburtamab Radioimmunotherapy ToTreat Recurrent Or Refractory Medulloblastoma
Rochester, MN
The purpose of this study is to assess 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3, to treat children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy.
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A Study Of DNA Markers For The Detection Of Metastatic Melanoma In Blood
Rochester, MN
The purpose of this study is to discover and validate DNA methylation-based markers that identify patients with metastatic melanoma based on the detection of such markers in patient blood with the ultimate goal of using blood-based multi-marker testing as a method of disease surveillance in melanoma patients.
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A Phase 3, Randomized, Open-label, Controlled Study Comparing The Efficacy And Safety Of Zanidatamab To Trastuzumab, Each In Combination With Physician’s Choice Chemotherapy, For The Treatment Of Participants With Metastatic HER2-positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy.
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Outcomes Database To ProspectivelY ASSEss The Changing TherapY Landscape In Renal Cell Carcinoma (ODYSSEY RCC)
Rochester, MN
The purpose of this study is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy.
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Adipose-Derived Mesenchymal Stem Cells (AMSCs) For Recurrent Glioblastoma
Jacksonville, FL
This study aims to evaluate the safety of local delivery of AMSCs for recurrent GBM by noting the incidence of adverse events, as well as radiological and clinical progression.
To assess the preliminary efficacy of local delivery of AMSCs for recurrent GBM by comparing the clinical, survival, progression, and radiographic outcomes from patients enrolled in our study to historical controls from our institution.
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Treatment Of Patients With Recurrent High-Grade Glioma With APG-157 And Bevacizumab
Rochester, MN
The purpose of this study is to assess the toxicity and effectiveness of bevacizumab with APG-157 for recurrent high grade glioma patients with disease progression after bevacizumab.
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A Study Assessing Robotic Surgery In The Seated Position For Benign And Malignant Lesions Of The Head And Neck Using The Da Vinci Robotic Surgical System
Rochester, MN
This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.
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Study Comparing CB-839 With Cabozantinib Vs. Cabozantinib With Placebo In Patients With Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.
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Erlotinib with or without Bevacizumab in Treating Patients with Stage IV Non-Small Cell Lung Cancer with EGFR Mutations
Rochester, MN
This randomized phase II trial studies how well giving erlotinib (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether erlotinib is more effective when given alone or with bevacizumab.
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A Dose Escalation Study Of Amivantamab In Participants With Advanced Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimen, and to assess the preliminary effectiveness of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).
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A Study Of Nivolumab And Multi-fraction Stereotactic Radiosurgery With Or Without Ipilimumab In Treating Participants With Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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A Study To Investigate LYL797 In Adults With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC patients only. The second part of the study will test that dose in additional TNBC patients and NSCLC patients.
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Study Of Retinfanlimab In Combination With INCAGN02385 And INCAGN02390 As First-Line Treatment In Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma Of The Head And Neck
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
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A Study To Evaluate Pembrolizumab For Surgically Treated Adjuvant Merkel Cell Carcinoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to determine how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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A Study To Evaluate Pemetrexed And Pembrolizumab To Treat Recurrent And/or Metastatic Salivary Gland Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the response rate of the combination of Pemetrexed and Pembrolizumab in patients with recurrent or metastatic salivary gland cancer (R/M SGC).
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Phase Ib Study Of Axatilimab In Combination With Olaparib In BRCA1/2 And PALB2- Associated Metastatic HER2-negative Breast Cancer
Rochester, MN
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer.
The names of the study drugs involved in this study are:
* Axatilimab (a type of antibody)
* Olaparib (a type of PARP inhibitor)
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VG161 In The Treatment Of Patients With Hepatocellular Carcinoma Or Intrahepatic Cholangiocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectie of Safety Run-In Cohort (Cohort 1) is to evaluate the safety and tolerability of multiple intratumoral injections (IT) of VG161 at the recommendated Phase 2 Dose (RP2D) in patients with HCC and ICC who have either disease progression or intolerable toxicity after the standard treatments.
The primary objective of HCC Cohort (Cohort 2) is to evaluate the efficacy of multiple IT injections of VG161 in patients with hepatocellular carcinoma (HCC).
The primary objective of ICC Cohort (Cohort 3) is to evaluate the efficacy of multiple IT injections of VG161 in patients with intrahepatic cholangiocarcinoma.
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Clinical Trial Of SP-2577 (Seclidemstat) In Patients With Relapsed Or Refractory Ewing Or Ewing-related Sarcomas
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of SP-2577 (seclidemstat) as a single agent and in combination with topotecan and cyclophosphamide (TC) in patients with relapsed or refractory Ewing sarcoma and select sarcomas.
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AZD5305 Vs Placebo In Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol To Reduce Incidence Of Heart Failure
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.
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GMCI Plus Standard Of Care Immune Checkpoint Inhibitor For Stage III/IV NSCLC
Rochester, MN
The purpose of this study is to evaluate whether CAN-2409 + prodrug added to standard of care immune checkpoint inhibitor (ICI) therapy will be safe and improve the outcome for Non-small Cell Lung Cancer (NSCLC) patients that have stable disease or readiographic progression after at least 18 weeks of ICI therapy or that have refractory disease after at least 9 weeks of ICI therapy.
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A Global Study To Assess The Effects Of Durvalumab + Domvanalimab Following Concurrent Chemoradiation In Participants With Stage III Unresectable NSCLC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following definitive platinum-based concurrent chemoradiation therapy (cCRT).
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Study Of Durvalumab + Tremelimumab With Chemotherapy Or Durvalumab With Chemotherapy Or Chemotherapy Alone For Patients With Lung Cancer (POSEIDON).
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this randomized, open-label, multi-center, global, Phase III study is to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
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A Study To Evaluate DS-1062a Combined With Pembrolizumab In Advanced Or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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A Study to Explore the Effects of the Measles Virus on Tumor Immunity
Rochester, MN
The purpose of this study is to explore the effects of the measles virus on tumor immunity in a laboratory-based study.
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A Study To Evaluate Oncologic Outcomes And Quality Of Life In Sinonasal Cancer Patients
Rochester, MN
This is a multi-site study with several other leading centers studying sinonasal cancers. The purpose of this study is to gain a better understanding of the treatment and significant morbidity associated with sinonasal cancer and identify the impact this disease has on quality of life. In addition, several additional endpoints will focus on survival and optimal treatment strategies. Additional components will also included genomic and molecular analysis of tumor tissue as we search for novel targets for therapy.
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Two Cancers, One Gene. Why Some People In Families Develop Melanoma Or Pancreas Cancer, While Still Others Never Develop Cancer (TCOG)
Rochester, MN
The overall purpose of this study is to understand the factors that increase susceptibility and expression of pancreatic cancer and melanoma in high risk families. Individuals who are affected with pancreas cancer and melanoma, as well as those without either cancer who have been identified as 1st or 2nd degree relatives of family members with pancreas cancer and melanoma, will be asked to participate. The participant will be asked to complete a survey about their health and family history of cancer and to give a blood sample for specific gene testing and storage for future research studies.
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Testing A Combination Of Vaccines For Cancer Prevention In Lynch Syndrome
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate if the combination of trivalent adenovirus-5 (Tri-Ad5) vaccines and IL-15 superagonist N-803 reduces the incidence of colorectal neoplasms in patients with Lynch syndrome (LS).
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Shear Wave Elastograph And Contrast Enhanced Ultrasound For The Treatment Of Lymphedema
Rochester, MN
Lymphaticovenous anstomosis is an effective surgery to treat lymphedema in the upper extremities secondary to cancer treatment. A crucial step is to identify patent lymphatic channels. Contrast enhanced ultrasound (CEUS) with intradermal injection of microbubbles is a promising method for lymphatic mapping in the upper extrmeities with lymphedema. The goals of the study are(1) to establish the preferred FDA approved microbubble agent (Lumason, Optison, Definity) for CEUS lymphatic mapping, (2) to identify lymphatic channels with CEUS and high-frequency ultrasound in patients receiving lymphaticovenous anastomosis surgery for upper extremity lymphedema, (3) and to validate the use of shear wave elastography for detecting improving in ...
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A Pilot, Randomized, Open-label Study Of Tumor Treating Fields (TTFields, 150 KHz) Concomitant With Pembrolizumab For First Line Treatment Of Advanced Or Metastatic Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the objective response rate (ORR) by RECIST 1.1 in subjects with TPS ≥ 1 percent.
The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Surgical Drain Fluid For Detection Of Molecular Residual Disease In Patients With Non-small Cell Lung Cancers
Rochester, MN
The purpose of this study is to characterize post-surgical drain fluid, pleural fluid, collected from the drainage device placed during surgery, as a biomarker for molecular residual disease in patients with non small cell lung cancer.
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Grid Radiation Therapy For The Treatment Of Stage IV Non-Small Cell Lung Cancer
Rochester, MN
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size ...
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Neoadjuvant Pembrolizumab
Rochester, MN
This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a type of immunotherapy that may enhance the ability of the immune system to fight off cancer. The study will investigate the effects of pembrolizumab on the immune system and how certain immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab. Previous studies suggest that pembrolizumab could alter the immune cells in a way that the the immune cells identify cancer ...
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A Study Of Neoadjuvant/Adjuvant Durvalumab For The Treatment Of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.
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Role of Eicosanoids in Intestinal Biology
Scottsdale/Phoenix, AZ
The purpose of this study is to see how the DNA methylation (a biochemical process involved in cell development) is activated during initial tumor growth and tumor progression. In order to look at this in patients with colorectal cancer or adenoma we must look at their tissue collected during surgery. Fresh tissue is required in order to study the primary cells in culture.
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A Study of the Ability to Predict Lymphedema Development Following Axillary Surgery for Breast Cancer and Its Effects on Patient Survivorship
Jacksonville, FL
The purpose of this study is to better understand the anatomy of the lymphatic structure and the molecular process that leads to the over production of lymph fluid. This proposal will begin intense lymphedema screening and identify baseline characteristics potentially predisposing someone to lymphedema, and identify molecular markers that might be altered to prevent lymphedema.
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5-strain Probiotic Formulation in Hormone Receptor-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
Jacksonville, FL
The purpose of this is a prospective, pilot, single-arm study to evaluate the median percent change in C-terminal telopeptide of type 1 collagen (CTx) after WBF-038 in early-stage breast cancer patients receiving aromatase inhibitors after 3- and 12-month treatment.
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Study Of Datopotamab Deruxtecan (Dato-DXd) In Combination With Durvalumab And Carboplatin For First-Line Treatment Of Patients With Advanced NSCLC Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
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A Study Of Selpercatinib Following Definitive Locoregional Treatment In Participants With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to compare Event-Free Survival (EFS) of participants in the primary analysis population with Stage II-IIIA RET fusion-positive Non-small Cell Lung Cancer (NSCLC) treated with selpercatinib versus placebo.
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Pembrolizumab, Dabrafenib, And Trametinib Before Surgery For The Treatment Of BRAF-Mutated Anaplastic Thyroid Cancer
Rochester, MN
This phase II trial studies the effect of pembrolizumab, dabrafenib, and trametinib before surgery in treating patients with BRAF V600E-mutated anaplastic thyroid cancer. BRAF V600E is a specific mutation (change) in the BRAF gene, which makes a protein that is involved in sending signals in cells and in cell growth. It may increase the growth and spread of tumor cells. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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Durvalumab And Grid Therapy For The Treatment Of Non-small Cell Lung Cancer In Patients Who Progressed During Or After Treatment With The PACIFIC Regimen
Rochester, MN
The purpose of this study is to determine whether combining grid therapy at the time of disease progression during durvalumab administration or shortly after durvalumab discontinuation may permit patients to continue on durvalumab which was otherwise effective at preventing polymetastatic disease.
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Study Of VS-6766 + Adagrasib In KRAS G12C NSCLC Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of Avutometinib combined with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.
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An Adjuvant Endocrine-based Therapy Study Of Camizestrant (AZD9833) In ER+/HER2- Early Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess if camizestrant improves outcomes compared to standard endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).
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Testing The Addition Of The Drug Atezolizumab To The Usual Radiation Treatment For Patients With Early Non-small Cell Lung Cancer
La Crosse, WI
This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy ...
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A Study To Evaluate The Addition Of Immunotherapy Into Adjuvant Therapy For Non-small Cell Lung Cancer
Rochester, MN
This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by ...
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Study Of Pembrolizumab With Ipilimumab Or Placebo In Participants With Untreated Metastatic Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.
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Effect of Agent Orange Exposure on Endocrine Tumor Aggressiveness
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The intent is to collect relevant clinical data on patients exposed to Agent Orange plus assessment of the tissue for genetic mutations known to be associated with growth of thyroid cancer and pituitary tumors and report our findings as a descriptive case series.
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Examination of the Pancreas in New-onset Diabetes
Rochester, MN
The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer
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Brachial Plexopathy in Breast Cancer Patients Undergoing Supraclavicular/Axillary Radiation Therapy
Jacksonville, FL
The purpose of this sstudy is to perform a retrospectively review patients who underwent regional nodal radiation therapy involving the supraclavicular region of the shoulder and to identify patients that subsequently developed a brachial plexopathy.
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Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Rochester, MN
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or ...
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A Study To Assess The Effectiveness And Safety Of Monalizumab Plus Cetuximab Compared To Placebo Plus Cetuximab In Recurrent Or Metastatic Head And Neck Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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Study To Evaluate Chemoembolization Combined With Durvalumab And Bevacizumab Therapy In Patients With Locoregional Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Study Of The Diagnostic Performance Of The Nonlinear Elasticity Parameter Mapping Method With Suspicious Breast Masses
Rochester, MN
The purpose of this study is to determine the diagnostic performance of the nonlinear elasticity parameter mapping method by associating its results with pathology in a population of patients with suspicious breast masses.
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Efineptakin Alfa (NT-I7) Plus Pembrolizumab For The Treatment Of Recurrent Glioblastoma
Rochester, MN
The purpose of this study is to determine the response rate to the combination of pembrolizumab and NT-I7 in patients with recurrent glioblastoma.
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Onvansertib For The Treatment Of Recurrent Or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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A Study To Analyze The Prevalence Of Depression And Anxiety In Newly-diagnosed Breast Cancer Patients In A Community Hospital
Albert Lea, MN; Austin, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to analyze the prevalence of mood disorders in newly-diagnosed breast cancer patients with use of specific questionnaires, aimed to diagnose clinically significant depression and anxiety, at a rural community hospital.
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A Study To Evaluate Ipilimumab Administered Intra-lymphatically Using The Sofusa® DoseConnect™ DEVICE With IV-administered Nivolumab In Patients With Metastatic Melanoma
Rochester, MN
The primary objective of the overall study is to determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through the DoseConnect™ device, followed 30 minutes later by nivolumab IV on Day 1 of a 21-day cycle in patients with metastatic melanoma.
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A Study Of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab For Resected High-Risk Melanoma In Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to compare MK-7684A to pembrolizumab with respect to RFS, and to determine if MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.
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A Study To Evaluate DS-1062a Combined With Pembrolizumab In Advanced Or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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A Study of Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia, or Refractory or Relapsed Acute Myelogenous Leukemia
Rochester, MN
RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may stop this from happening.
PURPOSE: Natural Killer (NK) ...
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A Study To Evaluate CC-96191 To Treat Participants With Relapsed Or Refractory Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and effectiveness of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.
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A Study Of Subcutaneous Nivolumab + Relatlimab FDC In Previously Untreated Metastatic Or Unresectable Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate pharmacokinetic non-inferiority for nivolumab + relatlimab FDC SC (fixed-dose combination for subcutaneous administration) formulation versus nivolumab + relatlimab FDC IV formulation.
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Futibatinib And Pembrolizumab For The Treatment Of Advanced Or Metastatic FGF19 Positive BCLC Stage A, B, Or C Liver Cancer
Rochester, MN
This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell ...
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Sonocloud-9 In Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU Or TMZ) In Recurrent GBM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB ...
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A Study Of Contribution Of 3D Models In Resection Of Renal Cell Cancer
Rochester, MN
The purpose of this study is to evaluate the impact on surgical planning and patient acceptance and understanding of 3D kidney tumor models prior to surgery.
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A Study To Develop And Validate Hybrid Molecular Imaging To Transform The Care Of Hepatocellular Carcinoma Patients
Rochester, MN
The primary purpose of this study is to evaluate diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) PET/MRI OR PET/CT for HCC using surgical histopathology (either resection, transplant or biopsy specimens) or LI-RADS® categorization as gold standard.
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A Phase 2 Study Of Atezolizumab (An Engineered Anti-PDL1 Antibody) As Monotherapy Or In Combination With Avastin (Bevacizumab) Compared To Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma [IMmotion150]
Jacksonville, FL
This multicenter, randomized, open-label study will evaluate the efficacy and safety of atezolizumab as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in patients with previously untreated locally advanced or metastatic renal cell carcinoma. Patients in Arm A will receive atezolizumab 1200 mg IV every 3 weeks (6-week cycles) plus Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive atezolizumab alone (until disease progression), and patients in Arm C will receive sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease progression, patients in Arms B and ...
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Study Of Iomab-B Prior To HCT Vs. Conventional Care In Older Subjects With Active, Relapsed Or Refractory AML
Jacksonville, FL; Rochester, MN
The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.
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Liposomal Cytarabine-Daunorubicin CPX-351, Fludarabine Phosphate, Cytarabine, And Filgrastim In Treating Younger Patients With Relapsed Or Refractory Acute Myeloid Leukemia
Rochester, MN
This phase I/II trial studies the side effects and best dose of liposomal cytarabine-daunorubicin CPX-351 (CPX-351) when given with fludarabine phosphate, cytarabine, and filgrastim and to see how well they work in treating younger patients with acute myeloid leukemia that has come back after treatment (relapsed) or is not responding to treatment (is refractory). Liposomal cytarabine-daunorubicin CPX-351 is made up of two chemotherapy drugs, cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and cytarabine, work in different ways to stop the growth of ...
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A Prospective Study To Establish A New Onset Hyperglycemia And Diabetes (NOD) Cohort
Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to prospectively assemble a cohort of subjects >50 and ≤85 years of age with New-onset Diabetes (NOD):
- Estimate the probability of pancreatic ductal adenocarcinoma (PDAC) in the NOD Cohort;
- Establish a biobank of clinically annotated biospecimens including a reference set of biospecimens from pre-symptomatic PDAC and control new-onset type 2 diabetes mellitus (DM) subjects;
- Facilitate validation of emerging tests for identifying NOD subjects at high risk for having PDAC using the reference set; and
- Provide a platform for development of an interventional protocol for early detection of sporadic PDAC ...
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A Study To Test The Combination Of Cabozantinib, Nivolumab, And Ipilimumab (CaboNivoIpi) For Advanced Differentiated Thyroid Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...
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A Study To Compare Of The Glycotest™ HCC Panel Vs AFP For The Detection Of Early-stage Hepatocellular Carcinoma
Rochester, MN
The purpose of this study is to compare the use of the Glycotest HCC Panel vs. the serum protein biomarker alpha-fetoprotein (AFP) for the early detection of Hepatocellular Carcinoma (HCC).
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Effect of Agent Orange Exposure on Endocrine Tumor Aggressiveness
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The intent is to collect relevant clinical data on patients exposed to Agent Orange plus assessment of the tissue for genetic mutations known to be associated with growth of thyroid cancer and pituitary tumors and report our findings as a descriptive case series.
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Examination of the Pancreas in New-onset Diabetes
Rochester, MN
The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer
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Brachial Plexopathy in Breast Cancer Patients Undergoing Supraclavicular/Axillary Radiation Therapy
Jacksonville, FL
The purpose of this sstudy is to perform a retrospectively review patients who underwent regional nodal radiation therapy involving the supraclavicular region of the shoulder and to identify patients that subsequently developed a brachial plexopathy.
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Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Rochester, MN
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or ...
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Study To Assess The Effectiveness And Safety Of Monalizumab Plus Cetuximab Compared To Placebo Plus Cetuximab In Recurrent Or Metastatic Head And Neck Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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Study To Evaluate Chemoembolization Combined With Durvalumab And Bevacizumab Therapy In Patients With Locoregional Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
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A Study Of The Diagnostic Performance Of The Nonlinear Elasticity Parameter Mapping Method With Suspicious Breast Masses
Rochester, MN
The purpose of this study is to determine the diagnostic performance of the nonlinear elasticity parameter mapping method by associating its results with pathology in a population of patients with suspicious breast masses.
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A Study Of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab For Resected High-Risk Melanoma In Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to compare MK-7684A to pembrolizumab with respect to RFS, and to determine if MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.
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A Study To Evaluate Ipilimumab Administered Intra-lymphatically Using The Sofusa® DoseConnect™ DEVICE With IV-administered Nivolumab In Patients With Metastatic Melanoma
Rochester, MN
The primary objective of the overall study is to determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through the DoseConnect™ device, followed 30 minutes later by nivolumab IV on Day 1 of a 21-day cycle in patients with metastatic melanoma.
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Testing The Addition Of Stereotactic Radiation Therapy With Immune Therapy For The Treatment Of Patients With Unresectable Or Metastatic Renal Cell Cancer, SAMURAI Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria.
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Efineptakin Alfa (NT-I7) Plus Pembrolizumab For The Treatment Of Recurrent Glioblastoma
Rochester, MN
The purpose of this study is to determine the response rate to the combination of pembrolizumab and NT-I7 in patients with recurrent glioblastoma.
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Onvansertib For The Treatment Of Recurrent Or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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A Study To Analyze The Prevalence Of Depression And Anxiety In Newly-diagnosed Breast Cancer Patients In A Community Hospital
Albert Lea, MN; Austin, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to analyze the prevalence of mood disorders in newly-diagnosed breast cancer patients with use of specific questionnaires, aimed to diagnose clinically significant depression and anxiety, at a rural community hospital.
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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A Trial Of TTI-621 For Patients With Hematologic Malignancies And Selected Solid Tumors
Jacksonville, FL; Rochester, MN
Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
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Methotrexate, Erlotinib, And Celecoxib For The Treatment Of Recurrent/Metastatic Oral Cavity Cancer In A Rural Midwest United States Population
Albert Lea, MN; La Crosse, WI; Rochester, MN
This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by ...
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Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Jacksonville, FL
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
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Myeloproliferative Neoplasm Pain Management and Patient Habit Survey
Scottsdale/Phoenix, AZ
This study aims to evaluate the complexities of Myeloproliferative neoplasms (MPN) pain and review current treatment strategies through an online survey of MPN patients. The results of this preliminary investigation will provide the groundwork for future prospective studies addressing the MPN symptom burden.
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A Study of Pancreatic Polypeptide Response in Patients with Diabetes Mellitus with and without Pancreatic Cancer
Rochester, MN
The purpose of this study is to determine if a blood test called "pancreatic polypeptide" can help distinguish between patients with diabetes mellitus with and without pancreatic cancer.
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Patient Satisfaction In Mohs Micrographic Surgery With Supplemental Lidocaine Jelly
Scottsdale/Phoenix, AZ
The purpose of this study is to assess how using lidocaine jelly in Mohs surgery impacts the overall quantity of lidocaine/epinephrine injectable needed to maintain anesthesia, and patients’ pain/anxiety associated with anesthesia injections.
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Nitrates And IL-8 In Barrett's Esophagus
Rochester, MN
The purpose of this study is to determine serum, saliva, and tissue levels of nitrates in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC); to compare serum and tissue levels of IL-8 with varying levels of BE dysplasia and EAC; and to determine whether there is an association between nitrate levels and IL-8.
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REFINE: Regorafenib Observational Study In Hepatocellular Carcinoma
Rochester, MN
The purpose of this observational study is to describe the safety and effectiveness of regorafenib in patients with uHCC under real world practice conditions.
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Nanopore Sequencing For Detecting Bacteria In Bile And Preventing Surgical Site Infections In Patients Undergoing Surgery For Benign Or Malignant Pancreatic Tumors
Rochester, MN
The objectives of this study are to reduce the rate of bacterobilia driven surgical site infection (SSI) in patients undergoing pancreatic head resection by providing surgical team with NS data in the post-operative setting, and to reduce cost of care through reduction in SSI and improved antibiotic stewardship.
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A Study To Evaluate The Venn Ovarian CAncer Liquid Biopsy
Jacksonville, FL
The primary purpode of this study is to determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the InterVenn Ovarian Cancer Liquid Biopsy among women with ovarian adnexal mass for which a surgery is planned.
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Study Of The Theranostic Pair RYZ811 (Diagnostic) And RYZ801 (Therapeutic) To Identify And Treat Subjects With GPC3+ Unresectable HCC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A single arm, open-label Phase 1/1b study of the theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable HCC
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Phase 3 Trial Of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment Of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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A Study Of Atezolizumab As Adjuvant Therapy In Participants With Renal Cell Carcinoma (RCC) At High Risk Of Developing Metastasis Following Nephrectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
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Dendritic Cell Therapy After Cryosurgery In Combination With Pembrolizumab In Treating Patients With Stage III-IV Melanoma That Cannot Be Remove By Surgery
Rochester, MN
This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients ...
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DSC-MRI In Measuring Relative Cerebral Blood Volume For Early Response To Bevacizumab In Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.
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A Study Of CART-TnMUC1 In Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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Rochester, MN
We wish to examine pancreatic adenocarcinoma cell lines to determine what genes are being expressed in the cells that might cause muscle wasting in patients. We will also perform chemical analyses of plasma obtained from these patients to identify substances that might be causing muscle wasting. Finally, we will examine proteins that are secreted by such cells to identify mediator is of cachexia or muscle wasting.
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Tumor Heterogeneity Of The Tumor Microenvironment In Malignant Pleural Mesothelioma (MPM)
Rochester, MN
The purpose of this study is to:
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Evaluate MPM tumor heterogeneity by determining the agreement of histology, molecular abnormalities, neo-antigen expression and immunological biomarkers between three tumor samples from MPM patients.
- Compare the information from tumor samples to pleural fluid, peripheral blood and density based radiomics analysis.
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Efficacy And Safety Of Tislelizumab In Combination With Fruquintinib In Participants With Selected Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).
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A Study Testing The Effect Of Immunotherapy (Ipilimumab And Nivolumab) In Patients With Recurrent Glioblastoma With Elevated Mutational Burden
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma ...
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DSC-MRI In Measuring Relative Cerebral Blood Volume For Early Response To Bevacizumab In Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.
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A Study Of CART-TnMUC1 In Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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Effect of Agent Orange Exposure on Endocrine Tumor Aggressiveness
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The intent is to collect relevant clinical data on patients exposed to Agent Orange plus assessment of the tissue for genetic mutations known to be associated with growth of thyroid cancer and pituitary tumors and report our findings as a descriptive case series.
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Examination of the Pancreas in New-onset Diabetes
Rochester, MN
The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer
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Brachial Plexopathy in Breast Cancer Patients Undergoing Supraclavicular/Axillary Radiation Therapy
Jacksonville, FL
The purpose of this sstudy is to perform a retrospectively review patients who underwent regional nodal radiation therapy involving the supraclavicular region of the shoulder and to identify patients that subsequently developed a brachial plexopathy.
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Sunitinib Malate with or without Gemcitabine Hydrochloride in Treating Patients with Advanced Kidney Cancer that Cannot be Removed by Surgery
Rochester, MN
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.
PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or ...
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A Study Of The Diagnostic Performance Of The Nonlinear Elasticity Parameter Mapping Method With Suspicious Breast Masses
Rochester, MN
The purpose of this study is to determine the diagnostic performance of the nonlinear elasticity parameter mapping method by associating its results with pathology in a population of patients with suspicious breast masses.
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A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme
Jacksonville, FL; Rochester, MN
The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.
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A Study To Assess The Effectiveness And Safety Of Monalizumab Plus Cetuximab Compared To Placebo Plus Cetuximab In Recurrent Or Metastatic Head And Neck Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effectiveness and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.
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A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM)
Rochester, MN
The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.
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Study To Evaluate Chemoembolization Combined With Durvalumab And Bevacizumab Therapy In Patients With Locoregional Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
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Testing The Addition Of Stereotactic Radiation Therapy With Immune Therapy For The Treatment Of Patients With Unresectable Or Metastatic Renal Cell Cancer, SAMURAI Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria.
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Efineptakin Alfa (NT-I7) Plus Pembrolizumab For The Treatment Of Recurrent Glioblastoma
Rochester, MN
The purpose of this study is to determine the response rate to the combination of pembrolizumab and NT-I7 in patients with recurrent glioblastoma.
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Onvansertib For The Treatment Of Recurrent Or Refractory Chronic Myelomonocytic Leukemia
Rochester, MN
This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.
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A Study To Analyze The Prevalence Of Depression And Anxiety In Newly-diagnosed Breast Cancer Patients In A Community Hospital
Albert Lea, MN; Austin, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to analyze the prevalence of mood disorders in newly-diagnosed breast cancer patients with use of specific questionnaires, aimed to diagnose clinically significant depression and anxiety, at a rural community hospital.
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A Study Of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab For Resected High-Risk Melanoma In Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study to compare MK-7684A to pembrolizumab with respect to RFS, and to determine if MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.
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A Study To Evaluate Ipilimumab Administered Intra-lymphatically Using The Sofusa® DoseConnect™ DEVICE With IV-administered Nivolumab In Patients With Metastatic Melanoma
Rochester, MN
The primary objective of the overall study is to determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through the DoseConnect™ device, followed 30 minutes later by nivolumab IV on Day 1 of a 21-day cycle in patients with metastatic melanoma.
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A Study Of LOXO-292 In Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, And Medullary Thyroid Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
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A Trial Of TTI-621 For Patients With Hematologic Malignancies And Selected Solid Tumors
Jacksonville, FL; Rochester, MN
Multicenter, open-label, phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
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A Study to Reduce Cardiomyopathy in Breast Cancer Patients Being Treated With Trastuzumab
Rochester, MN
The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.
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Individualized Temozolomide in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery
Rochester, MN
This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TMZ at different times, which are determined individually for each patient based on the phase (biorhythm) of the immune system response against the tumor may allow for a better drug response and may kill more tumor cells.
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Therapeutic Plasma Exchange With Enfortumab Vedotin And Pembrolizumab For Treatment Of Bladder Cancers
Rochester, MN
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The ...
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A Study Of Ultrasound Imaging Of Microscopic Blood Vessels As A Biomarker For Uterine Pathologies
Rochester, MN
The purpose of this study is to investigate the value of ultrasound imaging of microscopic blood vessels as a new biomarker for identifying the difference between benign and cancerous uterine pathologies, and to compare ultrasound imaging to the diagnostics of MRI and (if available), surgical pathology.
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A Study Using Contrast Enhanced Digital Mammography In Addition To Diagnostic Mammography And Ultrasound For Suspicious Breast Lesions To Decrease Biopsy Rates
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the accuracy of diagnosis with contrast enhanced digital mammography when used in addition to standard mammography or ultrasound in patients with suspicious findings.
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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
Rochester, MN
This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib ...
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A Clinical Study Of Ifinatamab Deruxtecan (I-DXd) In People With Metastatic Prostate Cancer (MK-2400-001)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,
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A Study To Assess Multiparametric MR Elastography (MRE) In Diagnosing And Monitoring Cirrhosis Or Hepatocellular Carcinoma (HCC) Patients
Rochester, MN
The primary purpose of this study is to is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for early identification of hepatocellular carcinoma (HCC) involvement, differentiation, and risks of microvascular invasion.
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A Study To Test Sacituzumab Govitecan Therapy In Patients With HER2-Negative Breast Cancer And Brain Metastases
Rochester, MN
The purpose of this study is to analyze the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse.
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A Study In Treating Patients With Kidney Cancer Undergoing Nephrectomy Comparing PERioperative Nivolumab Vs. Observation
Rochester, MN
The purpose of this randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone ...
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A Study To Evaluate UV1 Vaccination Plus Nivolumab And Ipilimumab In Treatment Of Melanoma
Scottsdale/Phoenix, AZ
The purpose of this study is to explore the effectiveness and safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.
UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma.
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An Investigational Scan (Ga-68 PSMA-11 PET/CT) For Detection Of Disease Recurrence Or Progression In Patients With Glioma
Rochester, MN
This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a ...
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A Study to Evaluate the Effectiveness and Safety of P276-00 for Mantle Cell Lymphoma that has Returned and/or is Resistant to Treatment
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine whether P276-00 is safe and effective for the treatment of Mantle Cell Lymphoma that has returned or is not responding to at least one previous line of treatment.
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A Study Screening Mammograms for Women in Their 40s: Mammography Choice
Rochester, MN
The purpose of this study is to help women in their late 30s and in their 40s, make decisions regarding breast cancer screening that align with each women’s values and preferences.
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A Study Of Lutetium Lu 177 Dotatate (Lutathera®) In Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Rochester, MN
The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.
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Pembrolizumab And Ibrutinib In Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery
Rochester, MN
This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.
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A Study of BI-RADS 4 and 5 Lesions that are Malignant and Increased Stiffness on MR Elastography Compared to Lesions that are Benign
Rochester, MN
The purpose of this study is to gather measurements of mechanical properties of BI-RADS 4 and 5 lesions in order to test the effectiveness of MR elastography (MRE) in differentiating benign versus malignant disease. We will also test the mechanical properties of bilateral breast tissue on MRE to find any correlation with breast density on mammograms.
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Hepatocellular Carcinoma Early Detection Strategy Study
Rochester, MN
The purpose of this study is to evaluate the usefulness of new markers found in blood that might help to diagnose of liver cancer (HCC) early among people with cirrhosis. We hope that this study will show that these new markers could identify HCC at an earlier stage where better treatment options are available.
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Validation Of A Blood Assay For The Detection Of BRAF Mutation Status In Patients With Metastatic Melanoma
Rochester, MN
The purpose of this study is to validate an internally developed assay for the detection of BRAF V600E mutations in cfDNA from the peripheral blood of patients with melanoma.
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Clinical Features, Prognostic Factors, Local Control Modalities, Survival, and Outcomes of Ewing Sarcoma in Pediatric and Adult Patients
Rochester, MN
The purpose of this study is to compare clinical features and outcomes for children and adults with Ewing Sarcoma at the same institution and add to the limited clinical literature on adults with Ewing Sarcoma.
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Detection Of Plasma DNA Methylation In Peripheral Blood From Patients With Hepatocellular Carcinoma
Rochester, MN
This study aims to investigate the utility of using plasma DNA methylation to detect measurable residual disease or early recurrence/progression of patients with hepatocellular carcinoma.
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A Study Patients With Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
Rochester, MN
The purpose of this study is to evaluate patient outcomes after undergoing 68Ga-PSMA PET/CT imaging prior to initiation of immunotherapy to identify PSMA PET/CT positive patients (estimated N=20) for long term follow up.
In adult patients with advanced, pathologically confirmed HCC who are not amenable to curative restriction, transplantation or ablative therapies, and have radiographically measurable disease by RECIST; eligible for atezolizumab/bevacizumab front line therapy.
- Specific Aim 1. To test the performance of novel biomarkers derived from PSMA PET/CT to measure response compared to RECIST criteria, in advanced HCC patients treated with immunotherapy.
- Specific Aim 2. To identify precision ...
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A Study To Assess Dendritic Cell Immunotherapy Plus Standard-of-Care To Treat Advanced Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to evaluate CMN-001 in a randomized trial between standard-of-care (SOC) (first line ipilimumab+nivolumab followed by second line lenvatinib+everolimus) with or without CMN-001.
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Tissue Reinforcement For Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Scottsdale/Phoenix, AZ; Jacksonville, FL
This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the ...
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The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study To Test Bone Marrow And Blood In Children With Leukemia That Has Come Back After Treatment Or Is Difficult To Treat - A Leukemia & Lymphoma Society And Children's Oncology Group Study
Rochester, MN
The purpose of this study is to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials.
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Study Of Vorasidenib And Pembrolizumab Combination In Recurrent Or Progressive IDH-1 Mutant Glioma
Jacksonville, FL
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
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Study Of NMS-03597812 In Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Rochester, MN
The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.
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Rochester, MN
We wish to examine pancreatic adenocarcinoma cell lines to determine what genes are being expressed in the cells that might cause muscle wasting in patients. We will also perform chemical analyses of plasma obtained from these patients to identify substances that might be causing muscle wasting. Finally, we will examine proteins that are secreted by such cells to identify mediator is of cachexia or muscle wasting.
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Tumor Heterogeneity Of The Tumor Microenvironment In Malignant Pleural Mesothelioma (MPM)
Rochester, MN
The purpose of this study is to:
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Evaluate MPM tumor heterogeneity by determining the agreement of histology, molecular abnormalities, neo-antigen expression and immunological biomarkers between three tumor samples from MPM patients.
- Compare the information from tumor samples to pleural fluid, peripheral blood and density based radiomics analysis.
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Efficacy And Safety Of Tislelizumab In Combination With Fruquintinib In Participants With Selected Solid Tumors
Scottsdale/Phoenix, AZ
The purpose of this research is to see how well fruquintinib works in combination with tislelizumab in participants with metastatic colorectal cancer (mCRC).
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A Study Testing The Effect Of Immunotherapy (Ipilimumab And Nivolumab) In Patients With Recurrent Glioblastoma With Elevated Mutational Burden
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma ...
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Study Of Vorasidenib And Pembrolizumab Combination In Recurrent Or Progressive IDH-1 Mutant Glioma
Jacksonville, FL
Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.
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Study Of NMS-03597812 In Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Rochester, MN
The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.
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Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT
Rochester, MN
To understand the mechanisms associated with diarrhea in patients receiving conditioning chemotherapy prior to autologous stem cell transplantation and to test the effects of the studied therapies on mechanisms that may be involved in the pathophysiology of diarrhea associated with conditioning chemotherapy.
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A Study of Application of Clonal Analysis to Study Flow Sorted Clinical Samples from Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ
This study is being done so researchers can study the genetics of your tumor to better understand how the tumor grows and spreads and collect a blood sample to analyze the genetic material (DNA).
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Outcomes Following Stereotactic Radiosurgery for Patients with Glomus Jugulare Tumors
Rochester, MN
The purpose of this study is to describe long-term hearing outcomes following stereotactic radiosurgery (SRS) for glomus jugulare tumors (GJT).
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Aggressive Malignancy PDX (Avatar) and Cryopreservation Program
Rochester, MN
The purpose of this study is to assess the ability to successfully create numerous validated patient-derived xenograft (PDX) models from patient tumor specimens obtained at surgery/biopsy via the new Pathology/TRAG cryopreservation protocol, and to generate a large catalog and repertoire of previously unavailable histologically validated PDX.
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Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue
No Locations
The primary objective of this study is to determine if exercise, fasting, or eating prior to the molecular breast imaging study will have an effect on the uptake of the tracer in the breast tissue.
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The Impact of Clinical Trials in Patients with Multiple Myeloma and Lymphoma
Rochester, MN
The purpose of this study is to evaluate quality of life over time in patients with multiple myeloma or lymphoma enrolled in clinical trials compared with patients on standard therapy.
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Retrospective Review of Patients with Thyroid Disorders at Mayo Clinic
Rochester, MN
The purpose of this study is to determine the optimal approach to the diagnosis and treatment of patients with thyroid disorders.
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Myeloproliferative Neoplasms (MPN) Socioeconomic Study
Rochester, MN
The purpose of this study is to identify the extent of socioecomonic burden posed by participation in clinical trials in patients with myeloproliferative neoplasms.
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A Study To Explore Quality Of Life According To Treatment Plan For Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.
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Ixazomib Citrate In Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory To Bortezomib
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) but is not resistant to bortezomib (refractory). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Valemetostat Tosylate (DS-3201b), An Enhancer Of Zeste Homolog (EZH) 1/2 Dual Inhibitor, For Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Rochester, MN
The purpose of this study is to characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.
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Study Of XmAb®819 In Subjects With Advanced Clear Cell Renal Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
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A Study Of XMT-1660 In Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and side effects of a drug called XMT-1660.
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A Study To Evaluate Advanced Development Of Desorption Electrospray Ionization Mass Spectrometry For Intraoperative Molecular Diagnosis Of Brain Cancer
Jacksonville, FL
The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.
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A Study To Evaluate Circulating Tumor DNA (CtDNA) And Immunophenotyping As Potential Biomarkers In Patients Undergoing Regional Nodal Irradiation For Breast Cancer
Rochester, MN
The purpose of this study is to estimate the circulating tumor DNA (ctDNA)detection rate and mutational load in breast cancer patients with indications for regional nodal irradiation.
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Pilot Study Of Care At Home For Monitoring Brain Tumor Patients
Rochester, MN
The purpose of this study is to determine the feasibility of completing serial remote cognitive, activity/sleep, and selfreport assessments in clinical trial participants who have previously received cranial radiation.
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Neuro-Oncology Care Priorities Of Patients And Caregivers
Rochester, MN
The purpose of this study is to conduct semi-structured interviews with patients who have primary and metastatic CNS tumors as well as caregivers of these patients.
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Study Of SX-682 Alone And In Combination With Oral Or Intravenous Decitabine In Subjects With Myelodysplastic Syndrome
Jacksonville, FL
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Testing The Addition Of An Anti-cancer Drug, Selinexor, To The Usual Chemotherapy Treatment (Temozolomide) For Brain Tumors That Have Returned After Previous Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of phase 1 of this trial is to determine the maximum tolerated dose of temozolomide followed by selinexor in recurrent glioblastoma patients as determined by dose-limiting toxicities [DLTs] and the total toxicity profile.
The purpose of phase 2 of this trial is to evaluate the effectiveness of sequentially administering temozolomide and selinexor in recurrent glioblastoma as determined by progression-free survival [PFS].
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Brain Tumor-Gut Axis Human Biorepository
Jacksonville, FL
The purpose of this study is to establish a Mayo Clinic Florida Brain Tumor-Gut Axis Human Biorepository by sequential collection of fecal, urine, blood, saliva, and/or tissue samples and clinical patient information.
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A Phase III, Safety, Tolerability And Efficacy Of Combination Treatment Of BL-8040 And G-GSF As Compared To Placebo And G-CSF For ThE MobilizatioN Of HematopoiEtic Stem Cells For Autologous TransplantatIon In SubjectS With MM
Rochester, MN
A total of 207 subjects will be randomized into the study which will employ a double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
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A Study To Evaluate Hepcidin Mimetic In Patients With Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to test different doses of PTG-300 to identify a dose that is safe and is possibly effective for reducing the need for phlebotomies in patients with Polycythemia vera who require routine phlebotomies.
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First In Human Study Of TUB-030 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer ...
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A Phase 1 Trial Of MK-4280 As Monotherapy And In Combination With Pembrolizumab With Or Without Chemotherapy Or Lenvatinib (E7080/MK 7902) In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a safety and pharmacokinetics study of MK-4280 as monotherapy and in combination with pembrolizumab (MK-3475) in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive MK-4280 as monotherapy or MK-4280 in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RPTD) for MK-4280 in combination with pembrolizumab in participants with advanced solid tumors.
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A Study Of The Drugs Selumetinib Vs. Carboplatin And Vincristine In Patients With Low-Grade Glioma
Rochester, MN
This study aims to demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).
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Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Mankato, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
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A Study Of Tolododekin Alfa (ANK-101) In Combination With An Anti-PD-1/PD-L1 Antibody In Participants With Advanced Non-Small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
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Quantitative Transmission Imaging Compared With MRI As Supplemental Screening For High Lifetime Risk Of Breast Cancer
Rochester, MN
This clinical trial compares the use of quantitative transmission imaging (QTI) to standard of care MRI as a supplemental screening tool for patients with a high lifetime risk of breast cancer. QTI is a single 3D ultrasound test intended to be used as an initial evaluation method for asymptomatic women identified with above-average risk for developing breast cancer. Using QTI may be an effective supplemental screening tool, compared to MRI for patients with a high lifetime risk of breast cancer.
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Mammographic Images And Genetic Data For Breast Cancer Risk Prediction
Rochester, MN
The purpose of this study is to recruit a sample of women in the Rochester Epidemiology Project who had mammography screening at either Mayo Clinic or Olmsted Medical Center between 2009 and 2024 to get a biospecimen that can be used as a source of DNA for GWAS genotyping arrays. Using a case-cohort design, we will randomly sample a representative subcohort for comparison and include
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Molecular Characterization Of Renal Cell Carcinomas And Melanomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to collect blood samples from Mayo Clinic patients with a diagnosis of Renal Cell Carcinoma (RCC) or Melanoma. The blood samples will be used to study immune cells which are the cells in our blood involved in protecting the body from disease and foreign invaders. The blood samples may also be used for future research of Renal Cell Carcinoma (RCC) or Melanoma at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.
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Lutetium 177Lu-Edotreotide Versus Best Standard Of Care In Well-differentiated Aggressive Grade-2 And Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)
Rochester, MN
The purpose of the study is to evaluate the effectiveness, safety and patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
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APL-101 Study Of Subjects With NSCLC With C-Met EXON 14 Skip Mutations And C-Met Dysregulation Advanced Solid Tumors (SPARTA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase 1 / 2 open-label study to assess the safety and tolerability of APL-101, to determine the RP2D and dose limiting toxicities for APL-101, and to obtain preliminary efficacy in subjects
with c-Met dysregulation in advanced malignancies and Non-Small Cell Lung Cancer (NSCLC). c-Met dysregulation will be determined by local/archival molecular pre-screening evaluations for eligibility of enrollment.
Mayo Clinic will be participating in both Part A (Phase 1) & (Phase 2) B of the study.
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A Study Of Afatinib Treatment For Patients With Epidermal Growth Factor Receptor Mutation Positive Non-Small Cell Lung Cancer, Who Are Age 70 Or Older
Scottsdale/Phoenix, AZ
The purpose of this study is to describe the occurence of adverse events which lead to the reduction in dose of afatinib in elderly patients with non-small cell lung cancer, who have common EGFR (epidermal growth factor receptor) mutations.
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A Study Of Sonidegib And Pembrolizumab In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.
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Methotrexate, Erlotinib, And Celecoxib For The Treatment Of Recurrent/Metastatic Oral Cavity Cancer In A Rural Midwest United States Population
Albert Lea, MN; La Crosse, WI; Rochester, MN
This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by ...
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A Study To Determine The Effects Of A Mechanical Device To Treat Swelling Of The Face And Neck Following Treatment For Cancer.
Scottsdale/Phoenix, AZ
This study aims to assess the utility of pharyngeal manometry measures as a novel approach in quantifying internal lymphedema and compare success rates in reducing internal lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). It also aims to assess efficacy of PCD and MLD and assess compliance of treatment in both groups. Lastly, it aims to identify voice and swallowing changes in both groups.
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Alisertib in Treating Young Patients with Recurrent or Refractory Solid Tumors or Leukemia
No Locations
This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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A Study of GDC-0449 and Erlotinib Hydrochloride, with or without Gemcitabine Hydrochloride for Treating Patients with Metastatic Pancreatic Cancer or Solid Tumors that cannot be Removed by Surgery
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449, and either with or without gemcitabine hydrochloride, for the treatment of patients who have metastatic pancreatic cancer or solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as GDC-0449 and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving GDC-0449 together with ...
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A Survey of Pheochromocytoma and Paraganglioma Patient Environment
Rochester, MN
The purpose of this study is to determine the association of environmental, geographic factors, as well as presence of comorbidities associated with hypoxia with development of pheochromocytomas and paragangliomas (PPGL), location of PPGL, and number of PPGL.
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Rochester, MN
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
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A Study of the Frequency of Hepatitis B, Hepatitis C, and Hepatocellular Carcinoma Among Minnesota's African Immigrants, and Their Knowledge of the Diseases.
Rochester, MN
The purpose of this study is to find the rate of Hepatitis B, Hepatitis C, and Hepatocellular Carcinoma in individual populations of African descendants living in Minnesota, and to see what the current knowledge, attitudes and practices of these immigrants are towards screening, vaccination, and disease management.
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Neoadjuvant Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) In Cutaneous Stage L-lll Melanoma
Rochester, MN
The sentinel lymph nodes in patients with melanoma are immunosuppressed and the investigators have shown this occurs early in the disease process. This regional nodal immunosuppression precedes nodal metastasis and may be required for nodal spread. Administration of GM-CSF has been used to alter the immune response to metastatic melanoma. The investigators propose to assess whether administration of a short course of GM-CSF preoperatively to patients about to undergo wide local excisions and sentinel lymph node dissection can alter the immune environment of the sentinel lymph node and restore an immune surveillance profile in the sentinel lymph node.
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A Master Protocol To Evaluate The Long-Term Safety Of (LY3527727) Pirtobrutinib
Rochester, MN
The purpose of this study is to evaluate the long-term safety of pirtobrutinib.
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Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.
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Short-course Radiation Therapy For Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the safety and effectiveness of 5 fraction stereotactic pencil beam scanning proton radiotherapy for the treatment of hepatocellular carcinoma (HCC).
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Musical Toxicity's Effect On Patient During Cancer Treatment
Rochester, MN
The purpose of this study is to produce a rich description of musicians’ experience as they go through cancer treatment and navigate recovery.
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Clinical Study Of Ivonescimab For First-line Treatment Of Metastatic NSCLC Patients
Jacksonville, FL; Rochester, MN
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
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A Trial Of Casdozokitug In Combination With Toripalimab Plus Bevacizumab In Participants With Unresectable And/or Locally Advanced Or Metastatic Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.
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A Study To Investigate The Safety And Efficacy Of KQB168 As Monotherapy And In Combination In Participants With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are:
* What is the safe dose of KQB168 by itself or in combination with pembrolizumab?
* Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor?
* What happens to KQB168 in the body?
Participants will:
* Take KQB168 daily, alone or in combination with pembrolizumab
* Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after ...
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Cerebrospinal Fluid Biomarkers For Brain Tumors
Rochester, MN
The purpose of this study is to help generate a repository of Cerebrospinal Fluid (CSF) samples relevant to neuro-oncology research that may facilitate the identification of biomarkers that are predictive of disease burden, therapeutic susceptibility or response to therapy. This protocol will also provide a vehicle for CSF access for patients or providers wishing to generate or evaluate individualized biomarkers as part of other research or individualized therapy protocols.
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Correlation of Hepatic MR Elastography with Histopathology and/or Abdominal MRI in Patients with Chronic Liver Disease and Malignancy
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the accuracy of non-invasive MRE (Magnetic Resonance Elastography) with the results of liver biopsy and/or MRI (Magnetic Resonance Imaging).
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Dasatinib And Quercetin With CAR T Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma
Rochester, MN
This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide ...
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Thoracotomy Versus Thoracoscopic Management Of Pulmonary Metastases In Patients With Osteosarcoma
Rochester, MN
The purpose of this study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.
Furthermore, to determine if open surgical resection is superior to thoracoscopy for event free survival (EFS), for overall survival (OS), and if thoracoscopy is superior to open surgical resection for postoperative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.
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A Study To Evaluate The Safety And Diagnostic Effectiveness Of Mangoral In Patients With Focal Liver Lesions And Reduced Kidney Function
Scottsdale/Phoenix, AZ; Jacksonville, FL
The overall purpose of this study is to evaluate the safety and diagnostic effectiveness of Mangoral in liver MRI in patients with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.
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A Study To Investigate The Safety And Efficacy Of KQB365 As Monotherapy And In Combination In Participants With Advanced Solid Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365.
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Remote Monitoring With Health-Coaching To Improve Quality Of Life In Older Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to test the feasibility of an intervention that combines a daily routine of mindful movements and breathing exercises, remote monitoring, and weekly telephonic health coaching based on motivational interviewing in older (age ≥ 65 years) patients with multiple myeloma (MM) who are on observation or maintenance therapy.
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Characterizing Ultrasound Vibroelastography Features Of Ocular Tumors
Rochester, MN
The purpose of this study is to characterize ultrasound vibro-elastography features of ocular tumors.
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Ommaya At Biopsy
Rochester, MN
The purpose of this study is to determine the feasibility of placing Ommaya reservoirs at the time of biopsy to enable longitudinal CSF monitoring.
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A Study To Establish A Research Tissue Bank For Myeloproliferative Neoplasms
Scottsdale/Phoenix, AZ
The purpose of this study is to credential novel therapeutic approaches which can then be transitioned to the clinic for near-term mechanism based clinical trials in this research consortium. There is a need for new treatments for myelofibrosis (MF) patients based on laboratory insight into disease pathogenesis. We will use primary patient samples to understand how different genetic mutations contribute to MF development and to test novel treatment approaches.
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A Study To Evaluate Effectiveness And Safety Of MBG453 In Combination With Azacitidine In Subjects With Intermediate, High Or Very High Risk Myelodysplastic Syndrome (MDS), Or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of MBG453, or placebo added to azacitidine, in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.
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A Study To Evaluate Encapsulated Rapamycin To Prevent Progression Of Familial Adenomatous Polyposis In Patients
Scottsdale/Phoenix, AZ
The purposes of this study are to analyze the frequency and severity of adverse events associated with low-dose encapsulated rapamycin in Familial Adenomatous Polyposis (FAP), to determine the recommended phase 2 dose (RP2D) based on assessment of safety, long-term tolerability, optimal blood levels, and clinical benefit, and to determine the effectiveness of eRapa in delaying polyp progression in patients with FAP compared to historic controls.
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A Study To Evaluate The Safety And Efficacy Of A2B395, An Allogeneic Logic-gated CAR T, In Participants With Solid Tumors That Express EGFR And Have Lost HLA-A*02 Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
* Phase 1: What is the recommended dose of A2B395 that is safe for patients
* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells
Participants will be ...
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Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.
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A Study to Review Registry of Salivary Gland Cancers for Histopathology and How They Were Managed
Scottsdale/Phoenix, AZ
The purpose of this study is to review the Mayo Clinic cancer registry for patients with metastatic or non-resectable salivary gland tumors, review the histopathology and evaluate treatment approaches focusing on how they correlated with the histopathology results.
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Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
Rochester, MN
This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The intent is to administer all treatment in the outpatient setting.
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Impact Of Temperature-sensitive Radiofrequency Ablation In Patients With Malignant Biliary Obstructions Undergoing Biliary Stenting
Rochester, MN
The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. Additionally, to describe the incidence of adverse events with combination RFA plus stenting.
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Phase I/II Study Of The Combination Of Blinatumomab And Asciminib In Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Jacksonville, FL; Rochester, MN
To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
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Collection Of Mayo SDH Mutant Paraganglioma Tumor Tissue For Establishment Of Cultured Tumor Cell Lines
Jacksonville, FL; Rochester, MN
The purpose of this study is to to develop cultured human tumor cell lines from paraganglioma/ pheochromocytoma (PGL) tumors.
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Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation For Children, Adolescents, And Young Adults With Acute Leukemia Or Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to compare the 1-year cumulative incidence of severe GVHD (from day of HCT) defined as Grade III-IV acute GVHD (aGVHD) and/or chronic GVHD (cGVHD) that requires systemic immunosuppression and to compare the disease free survival (DFS) (from time of randomization) in children and young adults (AYA) with acute myeloid leukemia (AML), acute lymphoid leukemia (ALL), and Myelodysplastic Syndrome (MDS) who are randomly assigned to haploHCT or to an 8/8 adult MUD HCT.
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A Study Of Genetic Testing In The Care Of Glioma Patients
Rochester, MN
The purpose of this study is to validate the effectiveness and clinical use of array and next generation sequencing tests in hopes of adopting these tests as standard of care and advancing glioma patient care and clinical practice at Mayo Clinic and beyond.
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Study Of [68Ga]FAPI-46 PET In Patients With Pancreatic Ductal Carcinoma
Rochester, MN
The purpose of this study is to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection.
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Intrapatient Comparison Of Urinary Radioactivity Following Piflufolastat (18F) And Flotufolastat (18F) PET In Men With Low PSA Biochemical Recurrence Of Prostate Cancer Following Radical Prostatectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
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Mindfulness-Based Intervention (Muse-S™) as an Adjunct During Diagnostic Work-up in Patients Presenting to the Undiagnosed Mass Clinic (UMC).
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the feasibility of the Mindfulness-Based Intervention Meditation Program to provide an effective and sustainable solution for reducing stress often experienced by patients newly identified as having an unknown mass.
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Pain Severity and Pain Interference Outcomes following Percutaneous MRI-Guided Laser Ablation and Cryoablation of Painful Peripheral, Soft Tissue Vascular Anomali
Rochester, MN
The purpose of this study is to determine if MRI-guided laser ablation and cryoablation result in significant improvements in both pain severity and pain interference measures at intermediate-term follow-up in patients with painful, soft-tissue vascular anomalies. The study will also test the hypothesis that immediate loss of intrinsic vascular anomaly T2 signal is an imaging biomarker to predict decreased pain and VA volume following MRI-guided laser ablation and cryoablation in patients with painful, soft-tissue vascular anomalies.
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Monoclonal Proteins by Blood Spot and Saliva
Rochester, MN
The purpose of this study is to assess the feasibility and develop procedures for detecting monoclonal proteins via finger pick blood spots and saliva. Data will be compared to results of serum data collected for patient care during the same time. The test will be evaluated qualitatively against venipunctured data tested by Mass Fix.
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A Study Of Biomarkers To Predict Cancer Therapy-related Cardiotoxicity
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to collect Biospecimens from patients who developed chemotherapy related cardiac toxicity (CRCT) and patients who are at a high risk for developing CRCT identified prior to the onset of therapy.
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A Study of Pharmacogenomics Results and Clinical Data of Patients with Chronic Myeloid Leukemia and Lung Cancer to Assess Current and Future Therapeutic Relevance
Rochester, MN
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for a group of patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of medications.
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A Study To Evaluate The Safety And Effectiveness Of NX9 For CT Imaging In Patients With Cancer Or GI Disease
Rochester, MN
The purpose of this study is to collect safety, effectiveness and pharmacokinetics (in a subgroup of subjects) data on the use of NX9 as an oral CT contrast agent.
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Turkey Tail Mushroom For Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Scottsdale/Phoenix, AZ
This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.
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A Study Of Ovarian Tissue Freezing For The Preservation Of Fertility In Children
Rochester, MN
The purpose of this study is to offer ovarian tissue cryopreservation to female pediatric patients (birth-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential. Since this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.
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A Study Of Four-Dimensional MRI For Image-Guided Radiation Therapy
Scottsdale/Phoenix, AZ
The purpose of this study is to develop and evaluate four-dimensional Magnetic Resonance Image (4DMRI) sequence to accurately map tumor motion for radiation treatment.
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Shear Wave Elastography For Intraoperative Brain And Glioma Stiffness Measurements
Jacksonville, FL
The purpose of this study is to determine the feasibility of utilizing ISWEU measurements intraoperatively and in the human brain to measure tissue stiffness.
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A Study To Evaluate The Safety And Effectiveness Of Metformin And Nelfinavir With Bortezomib In Patients With Relapsed And/or Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the maximum tolerated dose (MTD) of administering metformin in combination with nelfinavir in patients with relapsed/refractory multiple myeloma.
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IFX_HU2.0 As An Adjunctive Therapy To Pembrolixumab In Checkpoint Inhibitor Naive Subjects With Advanced Or Metastatic Merkel Cell Carcinoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) between subjects treated with intralesional administration of IFx-Hu2.0, as an adjunctive therapy, followed by pembrolizumab, and subjects treated with placebo followed by pembrolizumab using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of BL-M05D1 In Subjects With Solid Tumors
Scottsdale/Phoenix, AZ
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
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Study Of Pembrolizumab (MK-3475) In Participants With Relapsed Or Refractory Primary Mediastinal Large B-cell Lymphoma Or Relapsed Or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170)
Rochester, MN
In this study, participants with relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL) or relapsed or refractory Richter Syndrome (rrRS) will receive pembrolizumab (MK-3475). The efficacy of pembrolizumab in the treatment of rrPMBCL and rrRS will be evaluated.
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A Study Of Safety, Tolerability, Pharmacokinetic And Pharmacodynamics (PK/PD) In Patients With Hematologic Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of APG-2575 as well as dose escalation and dose expansion stages.
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A Study Of ONC201 For Patients With H3 K27M-mutant And/or Midline High Grade Gliomas
Jacksonville, FL; Rochester, MN
The purpose of this project is to provide expanded access to ONC201 for patients with previously-treated H3 K27M-mutant and/or midline high grade gliomas who cannot access ONC201 through clinical trials.
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Zanzalintinib Versus Everolimus In Participants With Locally Advanced Or Metastatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
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A Study Of Hepatocellular Carcinoma On The Somali Population
Rochester, MN
The purpose of this study is to explore the psychosocial impact of HCC among members of the Somali Community and identify areas of need that can be addressed from a psychological perspective.
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A Study of Using Ultrasound to Evaluate Masses in the Liver
Rochester, MN
The purpose of this study is to investigate the value of ultrasound imaging of small blood vessels and tumor stiffness as a new biomarker to characterize the disease and evaluate early treatment for cancer.
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Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated with Chemotherapy
Rochester, MN
This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy.
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Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients with Brain Metastases that have been Removed by Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
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Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection
Jacksonville, FL
We will be comparing circular grid to a strip electrode to record electrocorticography.
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Blood Brain Barrier Differences In Patients With Brain Tumors Undergoing Surgery
Rochester, MN
This pilot research trial studies blood brain barrier differences in patients with brain tumors undergoing surgery. Studying samples of tissue and blood from patients with brain tumors in the laboratory may help doctors to understand how well drugs get into different parts of a brain tumor. This may help them to determine which types of drugs may be best for treating brain tumors.
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Ultrasound Microvessel Imaging For Differentiation Of Ocular Tumors
Rochester, MN
The purpose of ths study is to evaluate a contrast-free ultrasound tool for the visualization and quantification of tumor microvessel morphologies, called quantitative high-definition microvessel imaging (qHDMI). This technology includes three components: (1) novel processing procedures to reveal small microvasculatures using high frame rate ultrasound imaging; (2) quantification procedures to analyze the morphology of the microvasculatures in terms of 10 parameters (e.g., tortuosity, branch angle, number of branch points, etc.); and (3) a classification method to automatically determine if the lesion is benign or malignant based on its morphological signature.
The proposed technique is noninvasive, affordable, portable, and ...
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Utility Of Gallium-68-DOTA-Octreotat PET/CT In The Characterization Of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
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Methylene Blue Mouthwash For Oral Mucositis Pain In Cancer
Rochester, MN
Evaluate the efficacy of methylene blue mouth wash for increasing oral intake and relieving pain in patients with oral mucositis related to cancer and/or cancer treatments.
Oral intake will improve after six doses of methylene blue mouthwash compared to usual care. Usual care is defined as the institutional standard of care at the study site which includes magic mouthwash (lidocaine/diphenhydramine/Maalox) and sodium bicarbonate oral rinse.
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A Pilot Study Using 18F-DOPA PET-guided Radiotherapy In Gliomas
Rochester, MN
For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and guide your radiation oncologist in determining locations to treat with radiation. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most ...
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Testing Teclistamab (TECVAYLI) In Combination With Iberdomide For Hard-to-Treat Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating hard-to-treat multiple myeloma. Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, ...
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A First-in-Human (FIH) Study To Evaluate The Safety And Tolerability Of VVD-159642 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
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A Study To Assess Metabolic Changes In The Blood With Standard Treatment In Patients With Gliomas
Rochester, MN
The purpose of this study is to generate preliminary data on the impact of standard, first line treatment on the plasma metabolome of patients with a new diagnosis of glioma.
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(Apex) Bezuclastinib In Patients With Advanced Systemic Mastocytosis
Scottsdale/Phoenix, AZ
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
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(Neo)Adjuvant IDE196 (Darovasertib) In Patients With Localized Ocular Melanoma
Rochester, MN
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
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Targeted Alpha-Particle Therapy For Advanced SSTR2 Positive Neuroendocrine Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of [ 212Pb]VMT-α-NET, an alpha particle radiation delivering agent targeted to somatostatin receptor type 2 (SSTR2).
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Radiation Therapy With Or Without Temozolomide In Treating Patients With Anaplastic Glioma
Jacksonville, FL; Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.
PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy ...
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A Study Of MT-0169 In Participants With Relapsed Or Refractory Multiple Myeloma Or Non-Hodgkin Lymphoma
Jacksonville, FL; Rochester, MN
The main purpose of this study is to evaluate the safety and tolerability of MT-0169 and establish the MTD (maximum tolerated dose)/ RP2D (recommended phase 2 dose). Maximum tolerated dose means the highest dose of a study drug that can be given with acceptable side effects. Recommended phase 2 dose means that dose is judged to be the most optimal for future study in patients with your disease. The study will also examine how the body handles MT-0169. This will be done by looking at the pharmacokinetics of MT-0169after a single dose and after repeat doses in people ...
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Proton Beam Or Intensity-Modulated Radiation Therapy In Preserving Brain Function In Patients With IDH Mutant Grade II Or III Glioma
Rochester, MN
This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if ...
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A Phase 1 Study Evaluating The Safety, PK, And Clinical Effects Of PT-112 In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.
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A Study Of The Safety, Effectiveness And Maximum Tolerated Dose Of Oral PQR309 For Patients With Advanced Solid Tumors
Rochester, MN
The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.
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A Study Of The Safety And Effectiveness Of HBI-8000 With Nivolumab To Treat Melanoma, Renal Cell Carcinoma And Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.
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Combination Study Of SV-BR-1-GM In Combination With INCMGA00012 And Retifanlimab
Jacksonville, FL
The purpose of this study is to evaluate SV-BR-1-GM in metastatic or locally recurrent breast cancer patients, in combination with the PD-1 inhibitor INCMGA00012 and the IDO inhibitor epacadostat. Patients who with advanced breast cancer who have failed prior therapies will be eligible to enroll in this study. The study will evaluate SV-BR-1-GM in combination with INCMGA00012 and epacadostat. Treatment cycles will be every 3 weeks with evaluations for tumor progression or response every 6-12 weeks.
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A Study of Characteristics and Post-surgical Outcomes of Pediatric Patients Diagnosed with Lipoblastoma
Rochester, MN
The purose of this study is to examine the characteristics and post-surgical outcomes of pediatric patients diagnosed with lipoblastoma.
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Genomic Analysis of Glioma Tissue Samples
Rochester, MN
The purpose of this study is to use stored glioma specimens stored by the Tissue Registry under the oversight of the Neuro-Oncology program.
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A Study of AFP464 for Treating Patients with Solid Tumors that are Metastatic or Resistant to Treatment, and Cannot Be Removed By Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of AFP464 for treating patients who have solid tumors that are metastatic or resistant to treatment, and that cannot be removed by surgery. Drugs used in chemotherapy, such as AFP464, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
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Symptom Assessment of Patients following Percutaneous Transesophageal Gastrostomy Tube Placement
Scottsdale/Phoenix, AZ
The purpose of this study is to measure the symptom response in patients with malignant bowel obstruction who have placement of a percutaneous transesophageal gastrostomy tube.
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Cardio-Oncology Clinic Registry
Rochester, MN
The purpose of this study is to establish a retrospective and prospective clinical registry of patients seen in the cardio-oncology clinic to characterize trends in the composition and outcomes of the population seen in the clinic, as well as initial clinical analyses on cardiovascular toxicities.
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Collecting Blood And Stool Samples To Detect Colorectal Cancer Or Advanced Neoplasia In Lynch Syndrome Patients, CORAL Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to to determine the sensitivity and specificity of a second-generation multi-target stool DNA test (mt-sDNA 2.0) (Cologuard 2.0®, Exact Sciences Corporation) for colorectal neoplasia (CRN) in subjects with Lynch syndrome.
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A Study Of Interviews To Evaluate The Content Validity Of Patient- Reported Outcomes For Use In Myelodysplastic Syndromes (MDS)
Rochester, MN
The primary objective of this study is to generate evidence for the content validity of the Functional Assessment of Cancer Therapy - Anemia (FACT-An) and the Quality of Life in Myelodysplasia Scale (QUALMS) for use in an MDS population. Specifically, the study aims to gain an understanding of the experience of patients with MDS, including the key symptoms and impacts, as well as assess the patient understanding and relevance of the FACT-An and QUALMS for use in patients with MDS such that they may be used as trial endpoints.
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Analysis Of Live Tumor Fragments Of Surgical Resections
Jacksonville, FL
The purpose of this study is to obtain unused resected tumor tissue sample and associated clinical data from patients enrolled in this study to research ex vivo treatment response and integrity of tumor microenvironment using omics analysis and imaging while maintaining cell stability in a live environment.
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A Study To Evaluate Remote Monitoring In Cancer Care
Rochester, MN
The objectives of this study are to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, and to develop patient-specific algorithms to predict the trajectory of CRS and or neurotoxicity and time to escalation of medical intervention is needed.
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Study To Determine The Impact Of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (A Chemical Tracer That Highlights Certain Cells During Imaging) During Planning For Proton Beam Radiation Therapy.
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.
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Comparing Retreatment Of 177Lu-DOTATATE PRRT Versus Everolimus In Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is tol compare the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable).
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Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
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A Study To Investigate The Efficacy And Safety Of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib In Adults With Relapsed/Refractory Mantle Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
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Study To Evaluate The Efficacy And Safety Of BGB-11417 In Participants With Waldenström's Macroglobulinemia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
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A Study Of ALX148 With Azacitidine For Higher Risk Myelodysplastic Syndrome
Rochester, MN
The purpose of this study is to evaluate ALX148 in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
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A Study Of Entrectinib (RXDX-101) For The Treatment Of Patients With Solid Tumors That Have NTRK1/2/3, ROS1, Or ALK Gene Rearrangements
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the response of entrectinib (RXDX-101) for the treatment of patients with solid tumors that have an NTRK1/2/3, ROS1, or ALK gene rearrangement.
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Ommaya Placement For Biomarker Collection
Rochester, MN
The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.
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Natural History of Brain Function, Quality of Life, and Seizure Control in Patients with Brain Tumor Who Have Undergone Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.
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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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A Study of Fluorine F 18 Fluorodopa-Labeled PET Scans for Planning Surgery and Radiation Therapy to Treat Patients who have Newly Diagnosed High- or Low-Grade Glioma Brain Cancer Tumors
Rochester, MN
The purpose of this study is to evaluate the use of fluorine F 18 fluorodopa-labeled PET scanning for the planning of surgery and radiation therapy to treat patients who have newly diagnosed high- or low-grade glioma brain tumors. New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scans, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.
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Cancer screening practices of individuals with Lynch Syndrome
Rochester, MN
This is a survey study to describe how women with Lynch syndrome are being screened for gynecologic cancer risk, their perception of cancer risk, and uptake of risk reducing surgery.
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A Study Of NT-175 In Adult Subjects With Unresectable, Advanced, And/or Metastatic Solid Tumors That Are Positive For HLA-A*02:01 And The TP53 R175H Mutation
Jacksonville, FL
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.
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Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed By Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance In Treatment-Naïve Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to determine the proportion of patients in complete response (CR) with peripheral blood (PB) MRD-negativity after up to 12 cycles of maintenance treatment with either the doublet of zanubrutinib/rituximab, or the triplet of zanubrutinib/rituximab/sonrotoclax, following BRAZAN induction (3 cycles of BR + zanubrutinib and 3 cycles of rituximab + cytarabine). Peripheral blood MRD will be measured by the clonoSEQ® assay, with the threshold for MRD negativity set at a sensitivity level of 1 x 10-5 (uMRD5).
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Quizartinib Or Placebo Plus Chemotherapy In Newly Diagnosed Patients With FLT3-ITD Negative AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
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A Study To Evaluate ALN-BCAT In Patients With Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
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Brain Tumor Induced Immunosuppression
Rochester, MN
The purpose of this study is to determine the presence of immunosuppressive molecules and immunosuppressive leukocytes in brain tumor patients’ blood.
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A Study to Evaluate Thymoma Recurrence
Rochester, MN
The purpose of this study is to evaluate thymoma recurrence rates in patients who underwent thymectomy.
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PSMA PET For Metastatic Adenoid Cystic Carcinoma (ACC)
Rochester, MN
The purpose of this study is to evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.
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A Registry for Data and Biospecimen of Cancer and Autoimmune Diseases
Rochester, MN
The purpose of this study is to establish a repository consisting of clinical information, radiological data, serum, peripheral blood lymphocytes, plasma, cerebrospinal fluid (CSF), DNA and tissue specimens collected prospectively from participants with cancer and autoimmune diseases.
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A Study Of Prehabilitation In Patients With Multiple Myeloma Receiving CAR-T Therapy
Rochester, MN
The purpose of this study is to evaluate the feasibility and acceptability of a 6-week home-based virtual prehabilitation program with remote monitoring in 20 patients ≥60 years with relapsed/refractory (R/R) multiple myeloma (MM) scheduled to receive CAR-T therapy at Mayo Clinic – Rochester.
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A Study To Evaluate CHIP And Hematological Toxicity After PRRT In Neuroendocrine Tumor Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overall objective of this project is to combine robust clinical data (e.g. prior chemotherapy or radiation exposure, cumulative radiotheranostic dose) with geneticclonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in radiotheranostic treated solid tumor patients.
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A Study To Evaluate Gleolan To Enhance Tumor Visualization In Patients With Newly-diagnosed Or Recurrent Meningioma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX).
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Study Of INBRX-109 In Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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Prehabilitation
Rochester, MN
Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.
It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer –specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer ...
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A Study To Evaluate AL102 To Treat Patients With Progressing Desmoid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of AL102 in patients with progressive desmoid tumors.
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Phase III Study Of Rilvegostomig In Combination With Bevacizumab With Or Without Tremelimumab As First-line Treatment Of Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
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A Study to Collect Ovarian Tissue from Girls Undergoing Fertility-preserving Cryopreservation
Rochester, MN
The purpose of this study is to study the handling of ovarian tissue, cryopreservation technology, and oocyte maturation for female pediatric cancer patients and other female patients whose future fertility will be affected due to a disease or treatment.
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Phase 1 Study To Investigate TCRTs KRAS Mutation In Unresectable, Advanced, And/or Metastatic Solid Tumors
Jacksonville, FL
Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
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Calaspargase Pegol On The Coagulation System In Pediatric Acute Lymphoblastic Leukemia (ALL) Patients
Rochester, MN
The purpose of this study is to evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in Pediatric Acute Lymphoblastic Leukemia (ALL) patients.
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Amino Acid Pet For Brain Tumors
Rochester, MN
The purpose of this study is to utilize amino acid PET such as 18F-DOPA PET/CT for use in brain tumor patients.
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A Study Of MCLA-128 In Patients With Solid Tumors Harboring An NRG1 Fusion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.
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PTT-936, An Alpha Kinase 1 (ALPK1) Activator, Alone Or In Combination With Anti-PD-1/L1 In Patients With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to evaluate the safety and tolerability of a pharmacologically active dose (PAD) range of PTT-936, which may include identification of the MTD, administered as a single agent in patients with advanced unresectable or metastatic solid tumors who have progressed after exhaustion of standard of care (SOC) or a SOC is not available.
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A Study To Assess Disease Activity And Adverse Events Of Intravenous (IV) Telisotuzumab Vedotin Compared To IV Docetaxel In Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with Non-Small Cell Lung Cancer (NSCLC) who have previously been treated.
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A Study To Evaluate The Accuracy Of The CapsoCam® Colon (CV-3) In Detecting Colonic Polyps Compared To Colonoscopy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is anticipated that the data from this clinical trial will be used to support marketing authorizations to commercialize the CapsoCam® Colon (CV-3).
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Studying The Effect Of Levocarnitine In Protecting The Liver From Chemotherapy For Leukemia Or Lymphoma
Rochester, MN
The purpose of this study is to compare the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma.
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A Study Of KK2269 In Adult Participants With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.
In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel ...
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Vigilant ObservatIon Of GlIadeL WAfer ImplaNT Registry
Scottsdale/Phoenix, AZ
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
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Pharmacokinetic Guided Dose Escalation And Dose Confirmation With Oral Decitabine And Oral CDAi In Patients With MDS
Scottsdale/Phoenix, AZ
This 2-stage, open-label study will evaluate safety and pharmacokinetics of ASTX727, as well as determine the dose for the study's second stage. In the second stage the selected dose will be confirmed and evaluated for clinical activity, including response rate.
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Study To Evaluate The Efficacy And Safety Of Lutathera In Patients With Grade 2 And Grade 3 Advanced GEP-NET
Rochester, MN
The purpose of this study is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
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Accelerated Vs Standard BEP Chemotherapy For Patients With Intermediate And Poor-risk Metastatic Germ Cell Tumours
Rochester, MN
The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
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Detection of Mutant Circulating Tumor (CT)Dna in Uveal Melanoma With Development of a Droplet Digital Pcr (Ddpcr) Assay
Rochester, MN
The purpose of this study is to design, develop and assess the performance characteristics of a ddPCR assay for the detection of mutations associated with uveal melanoma. The performance characteristics of the ddPCR assay for the detection of ctDNA mutation in uveal melanoma patients will be assessed by comparing the mutation results obtained for the ddPCR assay on blood to those obtained on paired paraffin embedded tumors.
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Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers
Rochester, MN
This laboratory study is looking at genetic mutations and environmental exposure in young patients with retinoblastoma and in their parents and young healthy unrelated volunteers. Gathering information about gene mutations and environmental exposure may help doctors learn more about the causes of retinoblastoma in young patients.
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Perfusion MRI For Therapy Response Assessment In Brain Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to improve patient care by optimizing and measuring magnetic resonance imaging methods for the early detection of brain cancer response to therapy.
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Telehealth Assessments With Glioma Receiving Oral Chemotherapy
Rochester, MN
The purpose of this study is to evaluate the safety, feasibility and acceptability of telehealth assessments for patients with GBM receiving oral chemotherapy.
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Phase 1-2 Study Of Low Dose ASTX727 (ASTX727 LD) In Lower Risk Myelodysplastic Syndromes
Jacksonville, FL; Rochester, MN
The purpose of this study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 Myelodysplastic Syndromes (MDS). This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses/schedules.
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A Study Of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy In Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Rochester, MN
The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in patients with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
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Paclitaxel, Ifosfamide And Cisplatin (TIP) Versus Bleomycin, Etoposide And Cisplatin (BEP) For Patients With Previously Untreated Intermediate- And Poor-risk Germ Cell Tumors
Rochester, MN
The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every patient and therefore newer treatments are needed.
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Gastrointestinal-Related Cancers and Diseases
Rochester, MN
The purpose of applying to the Institutional Review Board (IRB) for the collection of GI-related tissue is to enable comprehensive molecular investigations into the mechanisms underlying gastrointestinal cancers and diseases.
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A Trial To Evaluate The Safety Of GEN1046 In Patients With Malignant Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.
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Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer
Rochester, MN
This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
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A Study of Combination Chemotherapy for Treating Women with Stage II or Stage IIIA Breast Cancer that has Spread to the Lymph Nodes
Eau Claire, WI
The purpose of this study is to compare the effectiveness of two different combinations of chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
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Natural History of Brain Function, Quality of Life, and Seizure Control in Patients with Brain Tumor Who Have Undergone Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.
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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with multiple myeloma that has returned or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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A Study of Fluorine F 18 Fluorodopa-Labeled PET Scans for Planning Surgery and Radiation Therapy to Treat Patients who have Newly Diagnosed High- or Low-Grade Glioma Brain Cancer Tumors
Rochester, MN
The purpose of this study is to evaluate the use of fluorine F 18 fluorodopa-labeled PET scanning for the planning of surgery and radiation therapy to treat patients who have newly diagnosed high- or low-grade glioma brain tumors. New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scans, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.
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Cancer screening practices of individuals with Lynch Syndrome
Rochester, MN
This is a survey study to describe how women with Lynch syndrome are being screened for gynecologic cancer risk, their perception of cancer risk, and uptake of risk reducing surgery.
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PSMA PET For Metastatic Adenoid Cystic Carcinoma (ACC)
Rochester, MN
The purpose of this study is to evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.
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A Study To Evaluate ALN-BCAT In Patients With Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.
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Brain Tumor Induced Immunosuppression
Rochester, MN
The purpose of this study is to determine the presence of immunosuppressive molecules and immunosuppressive leukocytes in brain tumor patients’ blood.
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A Study to Evaluate Thymoma Recurrence
Rochester, MN
The purpose of this study is to evaluate thymoma recurrence rates in patients who underwent thymectomy.
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A Registry for Data and Biospecimen of Cancer and Autoimmune Diseases
Rochester, MN
The purpose of this study is to establish a repository consisting of clinical information, radiological data, serum, peripheral blood lymphocytes, plasma, cerebrospinal fluid (CSF), DNA and tissue specimens collected prospectively from participants with cancer and autoimmune diseases.
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A Study Of Prehabilitation In Patients With Multiple Myeloma Receiving CAR-T Therapy
Rochester, MN
The purpose of this study is to evaluate the feasibility and acceptability of a 6-week home-based virtual prehabilitation program with remote monitoring in 20 patients ≥60 years with relapsed/refractory (R/R) multiple myeloma (MM) scheduled to receive CAR-T therapy at Mayo Clinic – Rochester.
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A Study Of NT-175 In Adult Subjects With Unresectable, Advanced, And/or Metastatic Solid Tumors That Are Positive For HLA-A*02:01 And The TP53 R175H Mutation
Jacksonville, FL
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.
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Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed By Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance In Treatment-Naïve Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to determine the proportion of patients in complete response (CR) with peripheral blood (PB) MRD-negativity after up to 12 cycles of maintenance treatment with either the doublet of zanubrutinib/rituximab, or the triplet of zanubrutinib/rituximab/sonrotoclax, following BRAZAN induction (3 cycles of BR + zanubrutinib and 3 cycles of rituximab + cytarabine). Peripheral blood MRD will be measured by the clonoSEQ® assay, with the threshold for MRD negativity set at a sensitivity level of 1 x 10-5 (uMRD5).
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Quizartinib Or Placebo Plus Chemotherapy In Newly Diagnosed Patients With FLT3-ITD Negative AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
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A Study To Evaluate CHIP And Hematological Toxicity After PRRT In Neuroendocrine Tumor Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overall objective of this project is to combine robust clinical data (e.g. prior chemotherapy or radiation exposure, cumulative radiotheranostic dose) with geneticclonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in radiotheranostic treated solid tumor patients.
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A Study To Evaluate Gleolan To Enhance Tumor Visualization In Patients With Newly-diagnosed Or Recurrent Meningioma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX).
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Study Of INBRX-109 In Conventional Chondrosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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Prehabilitation
Rochester, MN
Physical activity plays an important role in reducing the adverse effects of cancer treatment. There are few studies using prehabilitation to improve peri-operative outcomes in patients undergoing cancer surgery. This study will pilot a program of structured activity for women undergoing neoadjuvant chemotherapy with the intent to improve their physical state prior to surgical intervention and thus improve outcomes.
It has been shown that patients with advanced ovarian cancer may suffer from high levels of cancer –specific distress, depression and anxiety. It has also been proposed that psychological resilience can favorably affect psychological and treatment-related outcomes in cancer ...
-
A Study To Evaluate AL102 To Treat Patients With Progressing Desmoid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of AL102 in patients with progressive desmoid tumors.
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Phase III Study Of Rilvegostomig In Combination With Bevacizumab With Or Without Tremelimumab As First-line Treatment Of Hepatocellular Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy
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A Study To Assess The Safety And Tolerability Of Atezolizumab In Combination With Other Immune-Modulating Therapies In Participants With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent ...
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Testicular Tissue Cryopreservation In Children
Rochester, MN
This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.
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A Study Of HFB200301 In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
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KO-2806 Monotherapy And Combination Therapies In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
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Immune Response To Antigens
Jacksonville, FL
The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.
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A Study To Evaluate The Safety And Efficacy Of A2B395, An Allogeneic Logic-gated CAR T, In Participants With Solid Tumors That Express EGFR And Have Lost HLA-A*02 Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
* Phase 1: What is the recommended dose of A2B395 that is safe for patients
* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells
Participants will be ...
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A Phase III, Safety, Tolerability And Efficacy Of Combination Treatment Of BL-8040 And G-GSF As Compared To Placebo And G-CSF For ThE MobilizatioN Of HematopoiEtic Stem Cells For Autologous TransplantatIon In SubjectS With MM
Rochester, MN
A total of 207 subjects will be randomized into the study which will employ a double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
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A Study Of The Safety And Effectiveness Of HBI-8000 With Nivolumab To Treat Melanoma, Renal Cell Carcinoma And Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.
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A Study Of Sonidegib And Pembrolizumab In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.
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A Study of Using Ultrasound to Evaluate Masses in the Liver
Rochester, MN
The purpose of this study is to investigate the value of ultrasound imaging of small blood vessels and tumor stiffness as a new biomarker to characterize the disease and evaluate early treatment for cancer.
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Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated with Chemotherapy
Rochester, MN
This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy.
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Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients with Brain Metastases that have been Removed by Surgery
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
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Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection
Jacksonville, FL
We will be comparing circular grid to a strip electrode to record electrocorticography.
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Blood Brain Barrier Differences In Patients With Brain Tumors Undergoing Surgery
Rochester, MN
This pilot research trial studies blood brain barrier differences in patients with brain tumors undergoing surgery. Studying samples of tissue and blood from patients with brain tumors in the laboratory may help doctors to understand how well drugs get into different parts of a brain tumor. This may help them to determine which types of drugs may be best for treating brain tumors.
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Lasofoxifene And Abemaciclib To The Combination Of Fulvestrant And Abemaciclib For Locally Advanced Or Metastatic ER+/HER2− Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the PFS of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer with an ESRl mutation.
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Ultrasound Microvessel Imaging For Differentiation Of Ocular Tumors
Rochester, MN
The purpose of ths study is to evaluate a contrast-free ultrasound tool for the visualization and quantification of tumor microvessel morphologies, called quantitative high-definition microvessel imaging (qHDMI). This technology includes three components: (1) novel processing procedures to reveal small microvasculatures using high frame rate ultrasound imaging; (2) quantification procedures to analyze the morphology of the microvasculatures in terms of 10 parameters (e.g., tortuosity, branch angle, number of branch points, etc.); and (3) a classification method to automatically determine if the lesion is benign or malignant based on its morphological signature.
The proposed technique is noninvasive, affordable, portable, and ...
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Utility Of Gallium-68-DOTA-Octreotat PET/CT In The Characterization Of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
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Methylene Blue Mouthwash For Oral Mucositis Pain In Cancer
Rochester, MN
Evaluate the efficacy of methylene blue mouth wash for increasing oral intake and relieving pain in patients with oral mucositis related to cancer and/or cancer treatments.
Oral intake will improve after six doses of methylene blue mouthwash compared to usual care. Usual care is defined as the institutional standard of care at the study site which includes magic mouthwash (lidocaine/diphenhydramine/Maalox) and sodium bicarbonate oral rinse.
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Study To Evaluate The Long-term Safety Of Rusfertide (PTG-300) In Subjects With Polycythemia Vera
Scottsdale/Phoenix, AZ
The purpose of this study is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 or Phase 3 study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.
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Evaluate REC-4881 In Patients With FAP (TUPELO)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to designed to characterize the safety, tolerability, PK, PD, and preliminary activity of REC-4881 administered orally (PO) at multiple doses on a once daily schedule in participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
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Metabolic Agents Pharmacodynamic Analyses After Brain Radiation
Rochester, MN
Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate). Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate).
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A Study To Evaluate The Safety, Effectiveness And Tolerability Of APG-2575 In Patients With Waldenström Macroglobulinemia
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-2575, alone or in combination with other therapeutic agents (ibrutinib or rituximab), in patients with Waldenström Macroglobulinemia (WM).
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A Study To See If Collecting Cells With A Brush Will Have A Better Rate Of Finding Cancer Cells In The Esophagus
Rochester, MN
The purpose of this study is to see if collecting cells from the lining of the esophagus with a brush in addition to the biopsies taken for standard medical care will have a better rate of finding cancer cells related to having Barrett's esophagus.
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Analyses Of Metabolic Agents Following Brain Radiation
Rochester, MN
The purpose of this study is to determine the feasibility of serial cerebrospinal fluid (CSF) assessments to evaluate the pharmacodynamic impact of agents targeting radiation-induced biology administered following completion of brain radiation.
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A Study To Evaluate Bleomycin, Carboplatin, Etoposide, Or Cisplatin In Treating Pediatric And Adult Patients With Germ Cell Tumors
Rochester, MN
The purpose of this study is to evaluate how well bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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A Study To Provide Expanded Access For The Treatment Of Cancers With Rearranged During Transfection (RET) Activation
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to provide expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
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Observation Or Radiation Therapy In Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed By Surgery
Rochester, MN
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
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Study Of E7386 In Participants With Selected Advanced Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
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Combination Study Of SV-BR-1-GM In Combination With INCMGA00012 And Retifanlimab
Jacksonville, FL
The purpose of this study is to evaluate SV-BR-1-GM in metastatic or locally recurrent breast cancer patients, in combination with the PD-1 inhibitor INCMGA00012 and the IDO inhibitor epacadostat. Patients who with advanced breast cancer who have failed prior therapies will be eligible to enroll in this study. The study will evaluate SV-BR-1-GM in combination with INCMGA00012 and epacadostat. Treatment cycles will be every 3 weeks with evaluations for tumor progression or response every 6-12 weeks.
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The Circulating Cell-free Genome Atlas Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.
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Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy
Rochester, MN
This pilot randomized clinical trial studies the effects, good and/or bad, of taking doxepin hydrochloride compared to placebo (inactive drug) in treating esophageal pain in patients with thoracic cancer receiving radiation therapy to the thorax with or without chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently shown to be helpful for mouth pain in patients receiving radiation therapy. Part of doxepin hydrochloride's drug action takes place at the surface of the esophagus, which may be helpful in reducing the pain caused by radiation therapy.
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Low Dose Aspirin For The Prevention Of Postpartum Related Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test whether a short course of aspirin can change the markers of inflammation in patients who have a benign finding within five years of their last pregnancy, and possibly reduce their risk of future breast cancer.
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A Study To Assess The Effectiveness And Safety Of Durvalumab Alone Or Combined With Bevacizumab In High Risk Of Recurrence HCC Patients After Curative Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.
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A Randomized Phase 2 Trial Of Axitinib And TRC105 Versus Axitinib Alone In Patients With Advanced Or Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
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A Study To See If Memantine Protects The Brain During Radiation Therapy Treatment For A Brain Tumor
Rochester, MN
This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or has come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.
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Retifanlimab And Epacadostat In Combination With Radiation And Bevacizumab In Patients With Recurrent Gliomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the combination of INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). Regimen A of this study has been completed and Mayo Clinic will only be participating in the Regimen B portion.
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Evaluation Of De-escalated Adjuvant Radiation Therapy For Human Papillomavirus (HPV)-Associated Oropharynx Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
This study is designed for patients with a cancer of the oropharynx (tonsils or base of tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks of daily radiation therapy. This study investigates a less intense radiation treatment following surgery that uses half the dose of radiation given over two weeks rather than six weeks. Patients will be randomly assigned to receive the less intense treatment versus the traditional treatment by coin flip. Patients are twice as likely to receive the less intense treatment during randomization.
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A Study To Develop A Biorepository Of Blood Samples From Cancer Patients Participating In The Gemini (IRB 19-006717) Protocol
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to develop a biorepository of blood samples from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies.
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Phase 2 Trial Of Voyager V1 In Combination With Cemiplimab In Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. Currently the study is enrolling only to the HNSCC cohort.
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A Study of New Mid-Infrared Imaging Technology for the Non-Invasive Detection of Cancer Tumors During Surgery
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the new mid-range infrared spectroscopy imaging technology as a non-invasive approach for detecting cancer tumors from the surrounding tissues during surgery.
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Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Rochester, MN
Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response.
Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma.
GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity ...
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Image-based Mapping Of Brain Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to combine MRI images with histologic and genetic analysis of cancer (from blood and tissue samples) to improve the overall accuracy of diagnosis and effectiveness of cancer treatment.
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Actinium Therapy For Late-stage Aggressive Sarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this clinical trial is to learn about the safety of drug \[Ac225\]RTX-2358 and the diagnostic imaging agent \[Cu64\]LNTH-1363S. Additionally Ratio Therapeutics will learn if \[Ac225\]RTX-2358 drug is effective in treating advanced sarcoma.
The main questions the study aims to answer in Phase/Part 1 of the trial are:
* Is \[Ac225\]RTX-2358 tolerable or does it cause toxicities (medical problems) in patients.
* What is the most tolerable dose of \[Ac225\]RTX-2358
* Does the treatment show effectiveness on advanced sarcoma
Participants will:
* Take drug \[Ac225\]RTX-2358 once every 8 weeks (4 cycle target; 6 cycle maximum) over a period of 12 months
* Visit the clinic ...
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DNA Sequencing-Based Monitoring Of Minimal Residual Disease To Predict Relapse In Aggressive B-cell Non-Hodgkin Lymphomas
Rochester, MN
The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy in the future.
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A Study To Determine How BI 907828 Is Taken Up In The Tumor And To Determine The Highest Dose Of BI 907828 That Could Be Tolerated In Combination With Radiation Therapy In People With A Brain Tumor Called Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.
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A Study To Investigate Efficacy & Safety Of Intratumoral INT230-6 Compared To US Standard Of Care In Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.
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A Phase 2b Clinical Study With A Combination Immunotherapy In Newly Diagnosed Patients With Glioblastoma - The ImmuneSense Study
Jacksonville, FL
The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma multiforme (GBM) participants treated with IGV-001 as compared with placebo.
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A Study To Evaluate Treatment Of Established Chemotherapy-induced Neuropathy With Fingolimod
Mankato, MN; Rochester, MN
The purpose of this study is to determine if the use of Fingolimod can reduce neuropathy caused by chemotherapy.
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A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Rochester, MN
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
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Letrozole in Treating Postmenopausal Women with Ductal Carcinoma in Situ
Rochester, MN
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.
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A Study Of WVT078 In Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to establish a safe and tolerated dose of single agent WVT078 in patients with relapsed and/or refractory Multiple Myeloma (MM).
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Phase 1/2 Study Of BDTX-1535 In Patients With Glioblastoma Or Non-Small Cell Lung Cancer With EGFR Mutations
Jacksonville, FL; Rochester, MN
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 ...
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Saliva And Remote Monitoring Of Active Cytomegalovirus Infection And Symptoms During Ovarian Cancer Treatment
Rochester, MN
The purpose of this project is to determine the feasibility and accuracy of using saliva to remotely monitor CMV infection in individuals receiving treatment for ovarian cancer.
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A Study to Compare Optimal MRI Timing for Pre-surgical Planning to LINAC-based Therapy
Rochester, MN
The purpose of this research is to compare two different standard-of-care pre-surgical imaging methods.
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Rochester, MN
This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.
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Phase 2 Trial Of Voyager V1 In Combination With Cemiplimab In Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. Currently the study is enrolling only to the HNSCC cohort.
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A Study to Compare Optimal MRI Timing for Pre-surgical Planning to LINAC-based Therapy
Rochester, MN
The purpose of this research is to compare two different standard-of-care pre-surgical imaging methods.
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Rochester, MN
This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.
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Deep Learning-based Automated Segmentation of Organs at Risk in Treat Head and Neck Radiotherapy
Rochester, MN
The purpose of this study is to validate the ability of GHMCA to produce expert-level contouring on retrospective Mayo data with a considerable time savings benefit.
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Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL
Rochester, MN
The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.
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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.
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A Study to Evaluate Dexamethasone Compared With Prednisone During Induction Therapy to Treat Patients with Newly-diagnosed, High Risk Acute Lymphoblastic Leukemia
Rochester, MN
AALL0232 is a COG group-wide phase III study designed for NCI high risk patients with acute lymphoblastic leukemia (ALL) from 1-30 years of age. Although event free survival and overall survival continue to increase for children with high risk ALL, CNS disease has become an increasing cause of treatment failure. There is evidence that both dexamethasone and high dose methotrexate prevent CNS relapse. To specifically address the relative increase in CNS events this study will test safety and efficacy of these two therapeutic interventions. The study utilizes a 2 x 2 factorial design with an augmented intensity BFM backbone. Patients ...
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A Study To Evaluate Daratumumab And Ibrutinib To Treat Relapsed / Refractory Chronic Lymphocytic Leukemia Treatment (DIRECT)
Jacksonville, FL
For cohort 1: The primary goal is to the determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are on/or are previously treated with ibrutinib.
For Cohort 2: The primary goal is to determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are naive to ibrutinib treatment.
Secondary Goals:
For Cohort 1
-Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy.
-The overall incidence of MRD (minimal ...
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Testing The Effects Of Novel Therapeutics For Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a ...
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Study Of Biomarker-Based Treatment Of Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
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A Study To Evaluate Gilteritinib Vs. Midostaurin In FLT3 Mutated Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for FLT3 AML.
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A Study to Evaluate Colorectal Polyps with Dietary Inflammation During Colonoscopy
Jacksonville, FL
Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States (1). Colorectal cancer arises from colonic polyps. The major types of polyps associated with colorectal cancer development are adenomatous (tubular which is most common and other types are villous and tubulovillous) and serrated (hyperplastic, sessile or traditional) polyps with varying degrees of dysplasia (2). Hyperplastic polyps are common but they have a low malignancy potential (3). There is evidence that colonic inflammation plays a major role in colon polyp and colorectal cancer development. For example, inflammatory bowel disease is a major ...
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients with Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells.
PURPOSE: This phase I trial studies the side effects and ...
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A Trial Of Pirtobrutinib (LOXO-305) Plus Venetoclax And Rituximab (PVR) Versus Venetoclax And Rituximab (VR) In Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
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A Study Of T-VEC And Radiation To Treat Localized Soft Tissue Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects of talimogene laherparepvec and radiation therapy to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.
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Safety And Anti-leukemic Activity Of Vodobatinib (K0706) For Treatment Refractory/Intolerant CML Failing ≥3 Prior Chronic Myeloid Leukemia Therapies
Jacksonville, FL
The purpose of this study is determine the safety, tolerability, pharmacokinetics and activity of K0706.
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A Study Of Siremadlin Alone And In Combination With Donor Lymphocyte Infusion In Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant
Jacksonville, FL
The purpose of this study is to confirm a safe dose and schedule as well as the preliminary effectiveness of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with acute myeloid leukemia (AML) who are in remission following allogeneic stem cell transplantation (allo-SCT) but are at high risk for relapse based on the presence of pre-transplant risk factors.
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A Study Of The Safety And Drug/Body Interactions Of BGB-3111 For Patients With B-Cell Lymphoid Malignancies
Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, drug/body interactions, and treatment effects of a new drug known as BGB-3111 in patients who have B-cell lymphoid malignancies.
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INdividualized Screening Trial Of Innovative Glioblastoma Therapy (INSIGhT)
Rochester, MN
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115
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Minimally Invasive Molecular Approaches For The Detection Of Barrett's Esophagus- High Grade Dysplasia And Esophageal Adenocarcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.
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A Study To Develop A Biorepository Of Blood Samples From Cancer Patients Participating In The Gemini (IRB 19-006717) Protocol
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to develop a biorepository of blood samples from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies.
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Study Of The Safety, Pharmacokinetics And Efficacy Of EDO-S101, In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
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Cutaneous Lymphoma Database
Scottsdale/Phoenix, AZ
The purpose of this study is to create a long-term, prospective database of cutaneous lymphoma that will lead to a better understanding of the biological behavior of cutaneous lymphomas as well as the effectiveness of interventions.
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Patients With Inflammatory Bowel Disease (IBD) Are At Increased Risk For Colorectal Cancer And Early Dysplasia
Rochester, MN
The purpose of the study is to:
- Map and compare the neoplasia-associated epigenetic field in IBD-CRN, sporadic CRN and controls.
- Measure sensitivity of DNA methylation for the detection of synchronous IBD-CRN as a complement or alternative to histologic diagnosis of dysplasia on random biopsies.
- Measure the density and types of lymphocytes infiltrating IBD-CRN tumors, sporadic tumors and the epigenetic field.
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An Expansion Study To Evaluate Dose Escalation, Safety And Tolerability Of SAR444881 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in ...
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LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
Rochester, MN
The purpose of this study is to investigate the safety, effectiveness, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by effectiveness that will be assessed from fluorescence imaging observations and data.
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Genetically Engineered Cells (MUC1-Activated T-Cells) For The Treatment Of MUC1 Positive Recurrent Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
Primary Goal: To determine the toxicity of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing multiple myeloma.
The rationale for using MUC1-stimulated T-cells to treat multiple myeloma is twofold. The first is that T-cell therapies have been shown to be active in myeloma, making it an attractive disease model for the proposed study. The other is that we are expanding and using naturally occurring myeloma-fighting T-cells which may offer benefits, particularly with respect to longevity, as compared to the methods currently being employed using CAR-T and bispecific antibodies. This is highly significant as one of the ...
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A Study To Develop A Screening Method To Provide Early Detection Of HPV-associated Oropharyngeal Squamous Cell Carcinoma (OSCC)
Jacksonville, FL
The purpose of this study is to develop a screening method to provide early detection of HPV-associated Oropharyngeal Squamous Cell Carcinoma (OSCC).
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A Study To Evaluate Trabectedin With Olaparib In Advanced Unresectable Or Metastatic Sarcoma
Rochester, MN
The purpose of this study is to evaluate how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body.
Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
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Tele-Medicine In An Advanced Prostate Cancer Clinic
Rochester, MN
The purpose of this study is to describe the use of tele-medicine during the COVID-19 pandemic in our advance prostate cancer practice and evaluate patient satisfaction.
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Surveillance Of Colorectal Dysplasia To Treat Inflammatory Bowel Disease With Wide Area Transepithelial Sample (WATS)
Rochester, MN
The purpose of this study is to determine if WATS 3D (The Wide Area Transepithelial Sample with three dimension analysis) can be used to adequately sample the colon and identify dysplasia in patients with Irritable Bowel Disease (IBD) undergoing surveillance.
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Acceptance And Commitment Therapy For Cancer Distress Among Rural And Urban Patients With Hepatobiliary Cancers
Rochester, MN
The purpose of this study is to assess standardized benchmarks of intervention feasibility and acceptability for remotely delivered, group ACT-HBC, as tested with a single-arm pilot study. Determine if there are changes in psychological variables from baseline to completion of the ACT-HBC intervention. To explore the preliminary impact of rural status on feasibility and acceptability of the intervention in addition to outcomes of distress and theory-based statistical mediators/psychological mechanisms of ACT-HBC.
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A Study Of Heated Intra-peritoneal Chemotherapy (H.I.P.E.C.) With Doxorubicin And Cisplatin In Pediatric Patients With Pelvic And Abdominal Rhabdomyosarcoma
Rochester, MN
The primary purpose of this study is to assess the feasibility of heated intra-peritoneal chemotherapy (HIPEC) with doxorubicin (DOXO) and Cisplatin (CDDP) after surgical resection of pediatric pelvic and abdominal tumors, and to assess morbidity, hospital length of stay and peri-operative mortality outcomes for pediatric patients with intraperitoneal sarcoma undergoing hyperthermic intraperitoneal chemotherapy.
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Individualized Treatment In Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based On EBV DNA
Rochester, MN
There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses ...
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A Study To Evaluate Effectiveness And Quality Of Life Outcomes Of Daratumumab In Relapsed/Refractory Multiple Myeloma Patients
Rochester, MN
The primary purpose of this study is to evaluate patient-reported health-related quality of life outcomes in subjects with Relapsed/Refractory Multiple Myeloma (RRMM) treated with daratumumab-based regimens in a real life setting.
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A Study To Understand Symptoms From Olaparib
Rochester, MN
The purpose of this study is to gather real-world, patient-reported experiences of ovarian cancer patients who have been prescribed olaparib; this experience will be captured in patients’ own words with qualitative research methodology.
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Safety And Preliminary Efficacy Assessment Of AZD7789 In Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma
Rochester, MN
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
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A Study To Evaluate The Safety Of HANAROSTENT® Biliary Flap Lasso Stent System Use To Treat Cancer Patients With Biliary Obstruction
Rochester, MN
The purpose of this study is to demonstrate clinical performance and safety of the fully covered (FC) HANAROSTENT® Biliary Flap Lasso Stent System with anti-migration flaps for the palliative treatment of malignant biliary obstruction.
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A Study Of Unesbulin Combined With Dacarbazine To Treat Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The primary purpose of this study is to determine the maximum tolerated dose (MTD) and overall safety profile of PTC596 in combination with dacarbazine for the treatment of advanced Locally Recurrent, Unresectable or Metastatic Relapsed/Refractory Leiomyosarcoma (LMS).
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Epigenomic Biomarkers of HIV-Associated Hepatocellular Cancer in Nigeria
Rochester, MN
The main objective of this study is to identify minimally invasive, blood-based methylomic markers by comparing blood cfDNA methylation patterns among HIV-infected and uninfected HCC patients, and in HIV-infected but HCC-free patients.
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A Study To Assess The Adverse Events And Change In Disease Activity In Adult Participants With Relapsed Or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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Nemvaleukin Alfa (ALKS 4230) Monotherapy In Patients With Advanced Cutaneous Melanoma Or Advanced Mucosal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
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A Study To Assess Financial Burden And Its Impact On Quality Of Life In Patients With Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Testing An Active Form Of Tamoxifen (4-hydroxytamoxifen) Delivered Through The Breast Skin To Control Ductal Carcinoma In Situ (DCIS) Of The Breast
No Locations
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
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Laryngeal Allograft Transplantation
Scottsdale/Phoenix, AZ
The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.
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A Study Of Tumor Markers To Assess Risk Of Recurrence Of Liver Cancer After A Liver Transplant
Jacksonville, FL
The purpose of this study is evaluation of tumoral markers at the time of transplant to assess recurrence risk, and assessment of tumor sensitivity to a panel of candidate therapeutics as a guide to adjunct or therapeutic therapies for recurrent hepatocellular cancers (HCC).
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First in Human Study to Determine the Safety, Tolerability and Preliminary Efficacy of an Anti-CXCR4 Antibody in Subjects with Acute Myelogenous Leukemia and Selected B-cell Cancers
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability of BMS-936564 (MDX-1338) in relapsed Acute myelogenous leukemia (AML) and other selected B-cell cancers and to determine the maximum tolerated dose (MTD) of the drug alone in relapsed/refractory AML
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Follow-up Letters for Subjects in the IRB# 13-001285 "Mayo Clinic Experience with Subjects Diagnosed with Diffuse Large B-cell Lymphoma (DLBCL)" Study
Rochester, MN
The longer follow-up on the subjects will improve the validity on any conclusions made from the IRB study #13-001285.
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A Study of the Changes in Nutrition Status of Patients with Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is to determine best practices for the assessment and timing of nutrition interventions in patients who have Acute Myeloid Leukemia (AML).
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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Decitabine In Combination With Standard Of Care Therapy For The Treatment Of Surgically Resectable HPV-Negative Head And Neck Cancer
Jacksonville, FL
This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower ...
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A Study Of MBG453 In Combination With Azacitidine And Venetoclax In AML Patients Unfit For Chemotherapy
Rochester, MN
This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax. The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax. The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment ...
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GATE1: A Multicenter Phase II Study Of Pirtobrutinib, Rituximab And Venetoclax Combination Therapy For Patients With Previously Untreated Mantle Cell Lymphoma
Rochester, MN
Primary Objectives:
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
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A Study To Evaluate At Home Administration Of Pertuzumab Combined With Trastuzumab To Treat Patients With HER2-Positive Breast Cancer During COVID-19 Pandemic
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of PH FDC SC when administered at home by an HHNP. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests (hematology, blood chemistry), LVEF assessments, and by physical examinations.
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A Study To Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients For T-cell Directed Immunotherapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate immune profile of Acute Myeloid Leukemia (AML) patients receiving Venetoclax plus Azacitidine induction chemotherapy.
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A Study Evaluating Temozolomide Vs. Temozolomide And Olaparib For Advanced Pheochromocytoma And Paraganglioma
Rochester, MN
The purpose of this study is to determine how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Anti-tumor Activity Of WSD0922-FU
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).
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A Study To Evaluate Effectiveness And Quality Of Life Outcomes Of Daratumumab In Relapsed/Refractory Multiple Myeloma Patients
Rochester, MN
The primary purpose of this study is to evaluate patient-reported health-related quality of life outcomes in subjects with Relapsed/Refractory Multiple Myeloma (RRMM) treated with daratumumab-based regimens in a real life setting.
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A Study To Understand Symptoms From Olaparib
Rochester, MN
The purpose of this study is to gather real-world, patient-reported experiences of ovarian cancer patients who have been prescribed olaparib; this experience will be captured in patients’ own words with qualitative research methodology.
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Safety And Preliminary Efficacy Assessment Of AZD7789 In Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma
Rochester, MN
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
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A Study To Evaluate The Safety Of HANAROSTENT® Biliary Flap Lasso Stent System Use To Treat Cancer Patients With Biliary Obstruction
Rochester, MN
The purpose of this study is to demonstrate clinical performance and safety of the fully covered (FC) HANAROSTENT® Biliary Flap Lasso Stent System with anti-migration flaps for the palliative treatment of malignant biliary obstruction.
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A Study Of Unesbulin Combined With Dacarbazine To Treat Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The primary purpose of this study is to determine the maximum tolerated dose (MTD) and overall safety profile of PTC596 in combination with dacarbazine for the treatment of advanced Locally Recurrent, Unresectable or Metastatic Relapsed/Refractory Leiomyosarcoma (LMS).
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Epigenomic Biomarkers of HIV-Associated Hepatocellular Cancer in Nigeria
Rochester, MN
The main objective of this study is to identify minimally invasive, blood-based methylomic markers by comparing blood cfDNA methylation patterns among HIV-infected and uninfected HCC patients, and in HIV-infected but HCC-free patients.
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A Study To Assess The Adverse Events And Change In Disease Activity In Adult Participants With Relapsed Or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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A Study To Assess Financial Burden And Its Impact On Quality Of Life In Patients With Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Nemvaleukin Alfa (ALKS 4230) Monotherapy In Patients With Advanced Cutaneous Melanoma Or Advanced Mucosal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
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Testing An Active Form Of Tamoxifen (4-hydroxytamoxifen) Delivered Through The Breast Skin To Control Ductal Carcinoma In Situ (DCIS) Of The Breast
No Locations
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
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Laryngeal Allograft Transplantation
Scottsdale/Phoenix, AZ
The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.
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A Study Of Tumor Markers To Assess Risk Of Recurrence Of Liver Cancer After A Liver Transplant
Jacksonville, FL
The purpose of this study is evaluation of tumoral markers at the time of transplant to assess recurrence risk, and assessment of tumor sensitivity to a panel of candidate therapeutics as a guide to adjunct or therapeutic therapies for recurrent hepatocellular cancers (HCC).
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Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo)
Scottsdale/Phoenix, AZ
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of one of these combinations. In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.
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Retrospective Study of Adult Acute Myeloid Leukemia and the Impact on Clinical Characteristics & Outcomes After Therapy
Jacksonville, FL
The purpose of this study is to perform a retrospective review of adult patients diagnosed with AML at all 3 Mayo Clinic sites over the past 25 years in order to identify prior exposures documented at presentation.
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A Study Using Octreotide Scan versus PET Scan in the Diagnosis and Follow-up of Patients with Carcinoid and Neuroendocrine Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if octreotide scans are more sensitive than PET scans for diagnosing carcinoid or neuroendocrine tumors.
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Analysis Of Outcomes In Sarcoma Reconstruction Using Intraoperative Fluorescence Angiography
Jacksonville, FL
The primary objective of the study is to compare outcomes of patients undergoing sarcoma reconstructive surgery using fluorescence angiography with patients undergoing sarcoma reconstructive surgery without fluorescence angiograph.
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Family Study Of Monoclonal B-Cell Lymphocytosis (MBL)
Rochester, MN
Given that family members of CLL patients are known to have an increased risk of CLL (on the order of 8-fold), and they have a higher prevalence of MBL than in an unselected sample of individuals, there is a need to understand the natural course of MBL in individuals from these high-risk families. This information may help us understand which MBL patients are likely to progress to clinical disease. Ultimately, the findings from this study may advance our understanding of the relationship between MBL and CLL, and may result in new approaches for the prevention, early detection, and treatment of ...
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A Study Of ASTX660 Alone Or Combined With ASTX727 In Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.
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A Study Of CGM In GBM
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare standard glucose monitoring versus continuous glucose monitoring (CGM) with endocrinology-guided intervention in newly diagnosed glioblastoma (GBM) patients receiving standard-of-care therapy.
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Wearable Artificial InTelligence For Cardiac Function And Health Monitoring
Rochester, MN
The purpose of thist study is to find a cost effective CV surveillance of cancer survivors over long periods of time to prevent the risk of progression of HF and related morbidity and mortality. Mobile device-based AI-ECG can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors and smart watch based surveillance for cardiotoxicity is feasible and reliable.
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Study To Evaluate The Safety And Efficacy Of Magrolimab In Combination With Azacitidine Versus Physician's Choice Of Venetoclax In Combination With Azacitidine Or Intensive Chemotherapy In Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia
Jacksonville, FL; Rochester, MN
The primary objective of this study is to compare the effectiveness of magrolimab + azacitidine versus venetoclax + azacitidine in adults with previously untreated TP53 mutant acute myeloid leukemia (AML) who are appropriate for non-intensive therapy as measured by overall survival (OS).
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Reduced Dose Hypofractionated Radiotherapy For Indolent Non-hodgkin Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of thisstudy is to evaluate reduction of radiotherapy dose for patients with indolent NHL by conducting a prospective randomized phase 2 study comparing reduced dose hypofractionated ISRT of 9 Gy delivered over 3 fractions (BED 12 Gy) to standard of care 24 Gy delivered over 12 fractions (BED 29Gy), while simultaneously evaluating prognostic value of pre-radiation functional imaging parameters and molecular markers to predict treatment response and failure.
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Comparing The Addition Of Radiation Either Before Or After Surgery For Patients With Brain Metastases
Jacksonville, FL
The purpose of this study is to compare the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases).
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Obtain Fresh Glioblastoma Tissue To Analyze Cell Count And Viability In Developing IGV-001
Jacksonville, FL
The purpose of this study is to utilize fresh tumor tissue to aid the development of future therapies for brain cancer.
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An Open-label Study Using ASP-1929 Photoimmunotherapy In Combination With Anti-PD1 Therapy In EGFR Expressing Advanced Solid Tumors
Rochester, MN
Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.
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Combination Chemotherapy With Or Without Blinatumomab In Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
Rochester, MN
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective ...
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A Study of the Prevalence of the Oropharyngeal Human Papillomavirus in Partners of Patients with Oropharyngeal Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
We are doing this research study to find out if partners of subjects with oropharyngeal cancer are infected with human papillomavirus (HPV) in their mouth or throat. Human papillomavirus causes some types of oropharyngeal cancer. It is not known if sexual partners of patients are at higher risk of having oral or throat HPV infection. It is also unknown if certain sexual behaviors increase the risk of oral HPV infection
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Assessment of Advanced Magnetic Resonance Imaging in the Prostate and Pelvis
Rochester, MN
The purpose of this study is to assess advanced imaging methods for the prostate and pelvis. Specifically, we are studying methods that allow us to acquire higher resolution images of the prostate and pelvis more quickly than our current imaging methods. These types of fast high resolution MRI acquisitions have been shown in the literature to improve cancer detection.
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A Study of STRO-001 in Patients with Advanced B-Cell Malignancies
Jacksonville, FL
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and preliminary effectiveness of STRO-001 given intravenously every 2 weeks to patients with advanced b-cell malignancies.
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Pre-operative Vs. Post-operative Radiosurgery For Metastatic Brain Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether there is an increase in the time of a first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients with brain metastases who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
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A Study of Idelalisib Combined with BI 836826 for Patients with Chronic Lymphocytic Leukemia
Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of the combination of idelallisib with the monoclonal antibody BI 836826 for the treatment of patients who have chronic lymphocytic leukemia that has returned or is resistant to treatment.
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A Study To Evaluate Pevonedistat, Azacitidine (Or Decitabine), And Venetoclax (PAVE) To Treat Acute Myelogenous Leukemia (AML) Patients
Rochester, MN
The purpose of this study is to determine a recommended phase 2 dose (RP2D) of pevonedistat, azacitidine (or decitabine), and venetoclax to treat Acute Myelogenous Leukemia.
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The NeoGlioma Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.
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Study To Evaluate The Efficacy And Safety Of Ersodetug In Patients With Inadequately Controlled Hypoglycemia Due To Tumor-Associated Hyperinsulinism
Rochester, MN
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in participants with inadequately controlled hypoglycemia due to islet-cell (insulinomas) and non-islet cell tumor hyperinsulinism.
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Daratumumab For Chemotherapy-Refractory Minimal Residual Disease In T Cell ALL
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the rate of complete MRD response by flow cytometry after 4 weekly doses of daratumumab-hyaluronidase (Day 29) among patients with MRD positive T-ALL in hematologic morphologic complete remission or complete remission with incomplete hematologic recovery. The secondary objectives include; evaluation of morphologic relapse free survival (RFS), evaluation of overall survival (OS), assessment of the the survival outcomes in patients that undergo allogeneic stem cell transplant after complete MRD response with daratumumab-hyaluronidase, assessment of adverse effects and tolerability of daratumumab-hyaluronidase in T-ALL, and assessment of flow cytometry based MRD status on Day 64 of ...
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A Study To Evaluate The Optune® (Tumor Treating Fields) Concomitant With RT & TMZ To Treat Newly-diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
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Testing The Addition Of Duvelisib Or CC-486 To The Usual Treatment For Peripheral T-Cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or ...
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Inotuzumab Ozogamicin In Treating Younger Patients With Relapsed Or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
Rochester, MN
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.
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AML: Treatment Of Relapse After Transplant Or Extended Maintenance Of Remission – Investigational Study (ARTEMIS)
Effectiveness Of MT-401 In Patients With AML Following Stem Cell Transplant
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate safety and effectiveness of MT-401 administration to patients with AML, who have received their first allogeneic HSCT.
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A Dose Escalation Study Of HFB301001 In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Rochester, MN
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
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Characterizing The Inflammatory Marker Profiles Of Free Flap Reconstructive Head And Neck Surgery
Rochester, MN
The purpose of this study is to characterize the inflammatory markers of free flap reconstructive head and neck surgery in humans by analyzing specific inflammatory markers in blood samples from patients with the hope of better understanding free flap physiology in order to eventually improve patient outcomes.
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A Study To Assess The Adverse Events And Change In Disease Activity In Adult Participants With Relapsed Or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
Rochester, MN
The purpose of this study is to characterize the safety and toxicity profiles of ABBV-453 in subjects with Relapsed/Refractory Multiple Myeloma (R/R MM). Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow.
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A Study To Assess Financial Burden And Its Impact On Quality Of Life In Patients With Plasma Cell Disorders
Rochester, MN
The purpose of this study is to evaluate the magnitude of financial toxicity in newly diagnosed and relapsed multiple myeloma (MM) and amyloidosis (AL) patients.
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Nemvaleukin Alfa (ALKS 4230) Monotherapy In Patients With Advanced Cutaneous Melanoma Or Advanced Mucosal Melanoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.
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Testing An Active Form Of Tamoxifen (4-hydroxytamoxifen) Delivered Through The Breast Skin To Control Ductal Carcinoma In Situ (DCIS) Of The Breast
No Locations
This randomized phase IIB trial studies how well tamoxifen or afimoxifene works in treating patients with estrogen receptor positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
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Laryngeal Allograft Transplantation
Scottsdale/Phoenix, AZ
The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.
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A Study Of Tumor Markers To Assess Risk Of Recurrence Of Liver Cancer After A Liver Transplant
Jacksonville, FL
The purpose of this study is evaluation of tumoral markers at the time of transplant to assess recurrence risk, and assessment of tumor sensitivity to a panel of candidate therapeutics as a guide to adjunct or therapeutic therapies for recurrent hepatocellular cancers (HCC).
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A Study of the Effectiveness of Sulfasalazine in Preventing Acute Diarrhea in Patients with Cancer who are Undergoing Pelvic Radiation Therapy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study of sulfasalazine is to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy. Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.
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Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
No Locations
This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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Decitabine In Combination With Standard Of Care Therapy For The Treatment Of Surgically Resectable HPV-Negative Head And Neck Cancer
Jacksonville, FL
This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower ...
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GATE1: A Multicenter Phase II Study Of Pirtobrutinib, Rituximab And Venetoclax Combination Therapy For Patients With Previously Untreated Mantle Cell Lymphoma
Rochester, MN
Primary Objectives:
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
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A Study Of MBG453 In Combination With Azacitidine And Venetoclax In AML Patients Unfit For Chemotherapy
Rochester, MN
This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax. The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax. The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment ...
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A Study To Evaluate At Home Administration Of Pertuzumab Combined With Trastuzumab To Treat Patients With HER2-Positive Breast Cancer During COVID-19 Pandemic
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety of PH FDC SC when administered at home by an HHNP. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests (hematology, blood chemistry), LVEF assessments, and by physical examinations.
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A Study To Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients For T-cell Directed Immunotherapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate immune profile of Acute Myeloid Leukemia (AML) patients receiving Venetoclax plus Azacitidine induction chemotherapy.
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A Study Evaluating Temozolomide Vs. Temozolomide And Olaparib For Advanced Pheochromocytoma And Paraganglioma
Rochester, MN
The purpose of this study is to determine how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Anti-tumor Activity Of WSD0922-FU
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).
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Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young
Rochester, MN
The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).
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Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
Rochester, MN
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central ...
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A Study of Fat Tissue Collection for Stem Cell Culturing, for Patients with Head and Neck Cancer
Rochester, MN
The purpose of this study is to obtain fat tissue from patients undergoing neck surgery for the treatment of upper head and neck cancer, and to prepare it in the lab as stem cells.
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Comparison of Mitoxantrone-Based Salvage Therapies (MEC vs CLAG-M) in Relapsed or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ
The purpose of this study is to determine potential differences between the 2 therapeutic regimens.
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A Study to Collect Adipose Harvest for Mesenchymal Stem Cell Derivation in Patients with Head & Neck Cancer
Rochester, MN
The purpose of this study is to collect adiopose tissue to derive mesenchymal stem cells.
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Study Of Treating Patients With Vestibular Schwannoma With Aspirin
Rochester, MN
The purpose of this study is to evaluate whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in patients with vestibular schwannoma (VS).
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A Study Of Hematopoiesis In Patients With Monoclonal B Cell Lymphocytosis (MBL), B-Chronic Lymphocytic Leukemia (CLL), And Healthy Controls
Rochester, MN
The purpose of this study is to determine the cellular and mechanistic basis of bone marrow hematopoietic dysfunction in untreated Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) patients.
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Study Of GI-102 And PD-1 In Glioblastoma
Rochester, MN
The purpose of this study to assess pharmacodynamic (PD) changes in tumor tissue.
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Short Course Radiotherapy For The Treatment Of Patients With Glioblastoma, SAGA Study
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.
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The Effects Of Acute And Chronic Exercise On Immune Phenotype Of Indolent Non-Hodgkin Lymphoma And Chronic Lymphocytic Leukemia Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase ...
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Dose-Escalated Photon IMRT Or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy And Temozolomide In Treating Patients With Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT ...
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A Study Of Using Geometrically Accurate Functional MRI To Enable Personalized Radiotherapy Of Glioblastoma
Scottsdale/Phoenix, AZ
The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma. MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.
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Hypofractionated Pre-Operative Radiation Therapy For Localized, Resectable Soft Tissue Sarcoma Of The Extremity Or Superficial Trunk
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity ...
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A Study To Evaluate HH2853 In Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas Or Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (how a drug moves within the body) and clinical activity of HH2853, an EZH1/2 Inhibitor, in patients with relapsed/refractory Non-Hodgkin's lymphomas or advanced solid tumors.
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A Study Of Ibrutinib With Rituximab In People With Untreated Marginal Zone Lymphoma
Rochester, MN
The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.
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Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, And Quality Of Life In Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
Scottsdale/Phoenix, AZ
The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study that longitudinally follows patients with MF-CTCL who are receiving therapy with Valchlor. Patients will be followed prospectively for a maximum of 1 year from the date of signed informed consent (enrollment) until end of study. Continuation in the study is not contingent on continuation of Valchlor.
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Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy
Rochester, MN
This pilot randomized clinical trial studies the effects, good and/or bad, of taking doxepin hydrochloride compared to placebo (inactive drug) in treating esophageal pain in patients with thoracic cancer receiving radiation therapy to the thorax with or without chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently shown to be helpful for mouth pain in patients receiving radiation therapy. Part of doxepin hydrochloride's drug action takes place at the surface of the esophagus, which may be helpful in reducing the pain caused by radiation therapy.
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Low Dose Aspirin For The Prevention Of Postpartum Related Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test whether a short course of aspirin can change the markers of inflammation in patients who have a benign finding within five years of their last pregnancy, and possibly reduce their risk of future breast cancer.
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A Study To Assess The Effectiveness And Safety Of Durvalumab Alone Or Combined With Bevacizumab In High Risk Of Recurrence HCC Patients After Curative Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.
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Retifanlimab And Epacadostat In Combination With Radiation And Bevacizumab In Patients With Recurrent Gliomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the combination of INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). Regimen A of this study has been completed and Mayo Clinic will only be participating in the Regimen B portion.
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A Randomized Phase 2 Trial Of Axitinib And TRC105 Versus Axitinib Alone In Patients With Advanced Or Metastatic Renal Cell Carcinoma
Scottsdale/Phoenix, AZ
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma. Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
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Evaluation Of De-escalated Adjuvant Radiation Therapy For Human Papillomavirus (HPV)-Associated Oropharynx Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
This study is designed for patients with a cancer of the oropharynx (tonsils or base of tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks of daily radiation therapy. This study investigates a less intense radiation treatment following surgery that uses half the dose of radiation given over two weeks rather than six weeks. Patients will be randomly assigned to receive the less intense treatment versus the traditional treatment by coin flip. Patients are twice as likely to receive the less intense treatment during randomization.
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A Study To See If Memantine Protects The Brain During Radiation Therapy Treatment For A Brain Tumor
Rochester, MN
This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or has come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor.
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Computerized Cognitive Test to Screen for Cognitive Changes in Patients with Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to measure subtle cognitive changes by using a simple and brief computer-based test (CogState Battery) in patients with Multiple Myeloma treated at Mayo Clinic in Scottsdale, Arizona.
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A Phase 2 Study Of Anti-PD-L1 Antibody Atezolizumab In Alveolar Soft Part Sarcoma
Rochester, MN
Background: Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS. Objective: To test good and bad effects of the drug atezolizumab. Eligibility: People at least 6 years old with ASPS that cannot be cured with surgery Design: Participants will be screened with heart and pregnancy tests. Some may ...
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A Study To Evaluate KIN-2787 In Participants With BRAF And/or NRAS Mutation Positive Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
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Carcinoid Syndrome Efficacy Study Featuring An Oral Daily Paltusotine Regimen
Rochester, MN
The purpose of this study is to assess the efficacy of paltusotine vs placebo in reducing flushing episodes.
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HEADLIGHT: Hypofractionated Proton Therapy For Head And Neck Cancers
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This study utilizes a shorter course of radiotherapy for patients who need radiation after surgery or without surgery for head and neck cancers. Radiation is typically given in 6-7 weeks for head and neck cancer using X-ray therapy, but this study will administer treatment in approximately 3 weeks. To achieve this shorter course, proton therapy is used. This study aims to determine cancer control at 2 years after study registration. It also aims to determine the rate and duration of grade 3 or higher acute (defined from treatment start to 30 days from radiation completion date) adverse events ...
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A Randomized Trial Of Pembrolizumab & Radiotherapy Versus Radiotherapy In High-Risk Soft Tissue Sarcoma Of The Extremity
Jacksonville, FL
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
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Hairy Cell Leukemia Patient Data Registry
Rochester, MN
The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 600 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends ...
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A Phase 1-2 Multi-Center Study Evaluating Axicabtagene Ciloleucel In Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).
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Testing The Use Of Steroids And Tyrosine Kinase Inhibitors With Blinatumomab Or Chemotherapy For Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia In Adults
Rochester, MN
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
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A Study to Compare Optimal MRI Timing for Pre-surgical Planning to LINAC-based Therapy
Rochester, MN
The purpose of this research is to compare two different standard-of-care pre-surgical imaging methods.
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Rochester, MN
This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Rochester, MN
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
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Characterizing The Inflammatory Marker Profiles Of Free Flap Reconstructive Head And Neck Surgery
Rochester, MN
The purpose of this study is to characterize the inflammatory markers of free flap reconstructive head and neck surgery in humans by analyzing specific inflammatory markers in blood samples from patients with the hope of better understanding free flap physiology in order to eventually improve patient outcomes.
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A Trial Of Enzastaurin Plus Temozolomide During And Following Radiation Therapy In Patients With Newly Diagnosed Glioblastoma With Or Without The Novel Genomic Biomarker, DGM1
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.
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A Study Of Ziftomenib, An Oral Menin Inhibitor, In Combination With Imatinib In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (GIST) who have been treated previously with imatinib.
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A Digital Treatment Platform For The Delivery Of Home-Based Sequential Therapy In Patients With Glioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while ...
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SL-401 In Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Hypereosinoophic Disorder, Chronic Myelomonocytic Leukemia)
Jacksonville, FL; Rochester, MN
This is a non-randomized open label multi-center study. Patients with high-risk myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic hypereosinoophic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia [CMML]) will be treated with SL-401, which will be administered as a brief intravenous infusion for 3 consecutive days initially every 21 days for 4 cycles; every 28 days for cycles 5-7; then every 42 days. Stage 1 will consist of a period in which several doses of SL-401 are evaluated. The Stage 2 portion will enroll up to 18 patients with each of the 4 myeloproliferative malignancies: SM, PED, MF, and CMML. ...
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Testing Proton Craniospinal Radiation Therapy Versus The Usual Radiation Therapy For Leptomeningeal Metastasis, RADIATE-LM Trial
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis).
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A Study To Evaluate Feasibility Of In Vivo Sensitivity Screen Using Direct Tumor Microinjection And FDG-PET In Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Or Stage IV Breast Cancer
Rochester, MN
The purpose of this study is to assess the safety of in vivo in host drug sensitivity testing in patients with breast cancer and patients with lymphoma (nodal, extranodal masses, or cutaneous lesions).
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Ibrutinib In Treating Minimal Residual Disease In Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy
Jacksonville, FL
This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Epidemiology Of Chronic Lymphocytic Leukemia
Rochester, MN
The overall goals of this study are to evaluate similarities and differences of the known genetic and non-genetic epidemiological factors associated with chronic lymphocytic leukemia (CLL) risk across African Americans, Hispanics, and Caucasian populations.
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Selection Of Allogeneic Hematopoietic Cell Donors Based On KIR And HLA Genotypes
Rochester, MN
The purpose of this study is to test whether adding certain genetic factors to the process of picking a stem cell donor can decrease the chances that the patient's leukemia will come back after bone marrow transplantation. Stem cell donors are "matched" based on genes called human leukocyte antigens (HLA). Currently, donors are selected largely on the basis of HLA gene typing alone. There is published data to show that donors with specific other genes called killer immunoglobulin-like receptors (KIR) may protect AML patients from having their leukemia return after a transplant. In this study, the best HLA matched donors will ...
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First In Human Study Of KO-539 To Treat Relapsed Or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).
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GPS Compared With BAT In AML CR2/CR2p
Jacksonville, FL
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best
available treatment (BAT) in patients with AML in second complete remission (CR2)
or in second complete remission with incomplete platelet recovery (CRp2). All
patients will have their historical bone marrow samples stained for WT1 via IHC by
central pathology review. The primary goal of the study will be to demonstrate an
advantage for GPS in overall survival in these patient populations. The study will
enroll approximately 116 patients and will be conducted at up to 50 investigational
sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are
in CR2 or ...
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A Study To Assess The Effectiveness And Safety Of Ublituximab In Combination With Umbralisib And Venetoclax (U2-V) Compared To Ublituximab And Umbralisib (U2) In Subjects With Chronic Lymphocytic Leukemia (CLL)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the effectiveness and safety of ublituximab in combination with umbralisib and venetoclax compared to ublituximab and umbralisib in subjects with previously-treated chronic lymphocytic leukemia (CLL).
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Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young
Rochester, MN
The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).
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Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
Rochester, MN
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central ...
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A Study of Fat Tissue Collection for Stem Cell Culturing, for Patients with Head and Neck Cancer
Rochester, MN
The purpose of this study is to obtain fat tissue from patients undergoing neck surgery for the treatment of upper head and neck cancer, and to prepare it in the lab as stem cells.
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Comparison of Mitoxantrone-Based Salvage Therapies (MEC vs CLAG-M) in Relapsed or Refractory Acute Myeloid Leukemia
Scottsdale/Phoenix, AZ
The purpose of this study is to determine potential differences between the 2 therapeutic regimens.
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A Study to Collect Adipose Harvest for Mesenchymal Stem Cell Derivation in Patients with Head & Neck Cancer
Rochester, MN
The purpose of this study is to collect adiopose tissue to derive mesenchymal stem cells.
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Study Of Treating Patients With Vestibular Schwannoma With Aspirin
Rochester, MN
The purpose of this study is to evaluate whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in patients with vestibular schwannoma (VS).
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A Study Of Hematopoiesis In Patients With Monoclonal B Cell Lymphocytosis (MBL), B-Chronic Lymphocytic Leukemia (CLL), And Healthy Controls
Rochester, MN
The purpose of this study is to determine the cellular and mechanistic basis of bone marrow hematopoietic dysfunction in untreated Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) patients.
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Study Of GI-102 And PD-1 In Glioblastoma
Rochester, MN
The purpose of this study to assess pharmacodynamic (PD) changes in tumor tissue.
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Short Course Radiotherapy For The Treatment Of Patients With Glioblastoma, SAGA Study
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.
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The Effects Of Acute And Chronic Exercise On Immune Phenotype Of Indolent Non-Hodgkin Lymphoma And Chronic Lymphocytic Leukemia Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase ...
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Dose-Escalated Photon IMRT Or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy And Temozolomide In Treating Patients With Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT ...
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A Study Of Using Geometrically Accurate Functional MRI To Enable Personalized Radiotherapy Of Glioblastoma
Scottsdale/Phoenix, AZ
The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma. MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.
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Hypofractionated Pre-Operative Radiation Therapy For Localized, Resectable Soft Tissue Sarcoma Of The Extremity Or Superficial Trunk
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity ...
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A Study To Evaluate HH2853 In Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas Or Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (how a drug moves within the body) and clinical activity of HH2853, an EZH1/2 Inhibitor, in patients with relapsed/refractory Non-Hodgkin's lymphomas or advanced solid tumors.
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A Study Of Ibrutinib With Rituximab In People With Untreated Marginal Zone Lymphoma
Rochester, MN
The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.
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Computerized Cognitive Test to Screen for Cognitive Changes in Patients with Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to measure subtle cognitive changes by using a simple and brief computer-based test (CogState Battery) in patients with Multiple Myeloma treated at Mayo Clinic in Scottsdale, Arizona.
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Carcinoid Syndrome Efficacy Study Featuring An Oral Daily Paltusotine Regimen
Rochester, MN
The purpose of this study is to assess the efficacy of paltusotine vs placebo in reducing flushing episodes.
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A Study To Evaluate KIN-2787 In Participants With BRAF And/or NRAS Mutation Positive Solid Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
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A Phase 2 Study Of Anti-PD-L1 Antibody Atezolizumab In Alveolar Soft Part Sarcoma
Rochester, MN
Background: Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS. Objective: To test good and bad effects of the drug atezolizumab. Eligibility: People at least 6 years old with ASPS that cannot be cured with surgery Design: Participants will be screened with heart and pregnancy tests. Some may ...
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HEADLIGHT: Hypofractionated Proton Therapy For Head And Neck Cancers
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
This study utilizes a shorter course of radiotherapy for patients who need radiation after surgery or without surgery for head and neck cancers. Radiation is typically given in 6-7 weeks for head and neck cancer using X-ray therapy, but this study will administer treatment in approximately 3 weeks. To achieve this shorter course, proton therapy is used. This study aims to determine cancer control at 2 years after study registration. It also aims to determine the rate and duration of grade 3 or higher acute (defined from treatment start to 30 days from radiation completion date) adverse events ...
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Hairy Cell Leukemia Patient Data Registry
Rochester, MN
The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 600 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends ...
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A Randomized Trial Of Pembrolizumab & Radiotherapy Versus Radiotherapy In High-Risk Soft Tissue Sarcoma Of The Extremity
Jacksonville, FL
This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
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A Phase 1-2 Multi-Center Study Evaluating Axicabtagene Ciloleucel In Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)
Rochester, MN
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).
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Testing The Use Of Steroids And Tyrosine Kinase Inhibitors With Blinatumomab Or Chemotherapy For Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia In Adults
Rochester, MN
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
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Cutaneous Lymphoma Database
Scottsdale/Phoenix, AZ
The purpose of this study is to create a long-term, prospective database of cutaneous lymphoma that will lead to a better understanding of the biological behavior of cutaneous lymphomas as well as the effectiveness of interventions.
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Patients With Inflammatory Bowel Disease (IBD) Are At Increased Risk For Colorectal Cancer And Early Dysplasia
Rochester, MN
The purpose of the study is to:
- Map and compare the neoplasia-associated epigenetic field in IBD-CRN, sporadic CRN and controls.
- Measure sensitivity of DNA methylation for the detection of synchronous IBD-CRN as a complement or alternative to histologic diagnosis of dysplasia on random biopsies.
- Measure the density and types of lymphocytes infiltrating IBD-CRN tumors, sporadic tumors and the epigenetic field.
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A Study of the Prevalence of the Oropharyngeal Human Papillomavirus in Partners of Patients with Oropharyngeal Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Rochester, MN
We are doing this research study to find out if partners of subjects with oropharyngeal cancer are infected with human papillomavirus (HPV) in their mouth or throat. Human papillomavirus causes some types of oropharyngeal cancer. It is not known if sexual partners of patients are at higher risk of having oral or throat HPV infection. It is also unknown if certain sexual behaviors increase the risk of oral HPV infection
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A Vaccine (H2NVAC) Before Surgery For The Treatment Of HER2-Expressing Ductal Carcinoma In Situ
Jacksonville, FL; Rochester, MN
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.
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Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer
Rochester, MN
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
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A Study To Test The Addition Of Nivolumab To Chemotherapy To Treat Soft Tissue Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cabozantinib may stop the growth of tumor ...
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Detection Of Circulating Biomarkers (Circulating Tumor Cells And Circulating Tumor DNA) In Patients With Head And Neck Carcinoma Following Surgical Intervention
Scottsdale/Phoenix, AZ
The goal of this research study is to evaluate the impact of surgical interventions on circulating biomarker dynamics and establish their prognostic role in carcinoma of the head and neck treated with intended curative surgery.
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A Study Using Clofarabine and Cytarabine in Treating Children with Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
No Locations
Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
The purpose of this trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)
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Immunomodulation And Patients` Outcomes Following Treatment Of Hepatocellular Carcinoma By Radiofrequency Ablation, Microwave Ablation, Trans-Arterial Chemoembolization Or Radio-embolization
Jacksonville, FL; Rochester, MN
The goal of the study is to identify immune responses (immune cell activation and suppression) following local ablation of liver tumors.
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A Study to Evaluate Liver Tumors with Ultrasound Microvessel Imaging and Shear Wave Elastography
Rochester, MN
The purpose of this study is to investigate the value of ultrasound imaging of tumor microvasculature and stiffness as new biomarkers for evaluation of liver tumor.
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A Study To Evaluate Sexual Function In Women Undergoing Radical Cystectomy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.
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A Study To Identify Novel High Quality Methylated DNA Markers In Renal Tumors
Rochester, MN
Primary Aims
- In tissue, to discover and validate DNA methylation markers (MDMs) for detection of malignant renal and urothelial tumors.
- In blood, to assess the accuracy of candidate MDMs from above for detection of malignant renal and urothelial tumors.
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A Study To Compare Standard Chemotherapy To Therapy With CPX-351 And/or Gilteritinib To To Treat Newly-diagnosed AML With Or Without FLT3 Mutations
Rochester, MN
The purpose of this study is to compare standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations.
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A Study Of Bendamustine And Rituximab Alone Versus In Combination With Acalabrutinib In Subjects With Previously Untreated Mantle Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
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FRACTIONATE
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
All lesions 4.0 cm to 6.0 cm will receive 32.5 Gy/5 fractions and will be analyzed separately. The portion of the trial is written as a phase II study without randomization noting the rarity of unresected brain metastasis of this size and the lack of comfort of treating radiation oncologist and neurosurgeons with single fraction SRS for tumors this large. However, noting the paucity of prospective data for this patient population enrolling patients on a clinical trial will provide a more accurate historical control for future trials. Although this cohort was enrolled on the prospective phase I trial from ...
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A Study To Determine The Effectiveness And Safety Of Luspatercept In Patients With Myelodysplastic/ Myeloproliferative Neoplasms With Ring Sideroblasts And Thrombocytosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to document the erythroid response rate assessed as per the 2015 International Working Group (IWG) MDS/MPN response criteria.
In this study we want to find out more about the side effects of a new drug combination for MDS/MPN-RS-T and MDS/MPN-U with RS, luspatercept with or without hydroxyurea and what doses of this combination are safe for people to take and how the disease responds to the treatment. There are 2 groups of patients being studied in this trial. One group of patients will receive luspatercept. The other group will receive luspatercept and hydroxyurea. ...
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Phase II Study Of Bendamustine And Rituximab Plus Venetoclax In Untreated Mantle Cell Lymphoma Over 60 Years Of Age (PrE0405)
Rochester, MN
The purpose of this study is to evaluate venetoclax, bendamustine and rituximab as induction therapy in eligible untreated patients. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see if venetoclax in combination with ...
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A Study To Evaluate Ruxolitinib For The Treatment Of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Scottsdale/Phoenix, AZ
The purpose of this study is to provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
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A Study To Investigate The Safety And Tolerability Of Ziftomenib In Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, Or 7+3+Quizartinib In Patients With AML
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.
The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
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A Study To Compare Stereotactic Radiosurgery To Hippocampal-Avoidant Whole Brain Radiotherapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 or more brain metastases.
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A Study To Evaluate The Safety And Effectiveness Of ALLO-501A CAR T Cell Therapy In Adults With Relapsed/
Refractory Large B Cell Lymphoma
Scottsdale/Phoenix, AZ
The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).
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A Study To Evaluate Itacitinib For Low Risk Graft-vs-Host Disease (GVHD)
Rochester, MN
The purpose of this study is to test whether patients with low risk Great-vs-Host Disease (GVHD) can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD).
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ROR1771: A Prospective Observational Study Of Proton Stereotactic Body Radiation Therapy And Immunotherapy For Recurrent/Progressive Locoregional Or Metastatic Head And Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
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Collection of Tissue, Blood Samples, and/or Cystic Fluid in Patients with Benign, Premalignant and/or Malignant Gastrointestinal (GI) Disease
Scottsdale/Phoenix, AZ
The goal of this study is to establish and maintain a gastrointestinal disease biospecimen bank containing samples of neoplasms, normal tissue, blood and/or any other tissue or cystic fluid from patients undergoing a diagnostic or therapeutic procedure for gastrointestinal disease.
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Female Patients And Female Partners Of Patients With Confirmed HPV Associated Oropharyngeal Carcinoma (Pap-Op): Prospective Assessment Of HPV Associated Anogenital Pathology
Rochester, MN
The purpose of this study is to determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.
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Early Pancreatic Cancer Detection
Jacksonville, FL
The primary purpose of this study is to standardize the collection of demographic, clinical, and imaging data, and biosamples for a large high-risk familial Pancreatic Ductal Adenocarinoma (PDAC) cohort at consortium clinical cancer centers, worldwide.
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Colorectal Cancer And Peripheral Neuropathy Study
Jacksonville, FL
The purpose of this study is to prospectively evaluate the development of neuropathy symptoms and corresponding changes in physical function in persons receiving oxaliplatin based chemotherapy.
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Effect Of TTFields (150 KHz) In Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program
Jacksonville, FL
This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...
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Study Of TJ011133 In Participants With Relapsed/ Refractory Advanced Solid Tumors And Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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A Study To Collect Thoracic Specimens To Develop A Thoracic Specimen Registry
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases.
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A Study To Evaluate Exercise For Cancer Patients At Risk Of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.
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The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)
Rochester, MN
The main purpose of this study is to utilize a comprehensive, prospective clinical database to collect patient, diagnostic and treatment variables along with disease specific and generic health related quality of life (HRQOL) data on consecutively treated patients with metastatic spine tumors. The objectives are to determine the validity and reliability of the Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool for predicting the stability of spine in metastatic spine disease, and to determine the efficacy of surgery versus radiotherapy ...
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Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors
Rochester, MN
The purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory. Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.
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Chemotherapy For The Treatment Of Patients With Newly Diagnosed Very Low-Risk And Low Risk Fusion Negative Rhabdomyosarcoma
Rochester, MN
The purpose of this study is to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma.
Additionally, to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes ...
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Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.
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Ixazomib Citrate, Lenalidomide, Dexamethasone, And Daratumumab In Treating Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...
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Nivolumab And Brentuximab Vedotin In Treating Older Patients With Untreated Hodgkin Lymphoma
Rochester, MN
This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.
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Advanced MR Imaging In Sarcoma Patients
Rochester, MN
The purpose of this study is to compare the clinical application of two emerging magnetic resonance (MR) imaging modalities which Mayo Clinic has the technical capability of using, by adding them at the same time that standard imaging is done for patients receiving treatment for Ewing Sarcoma , Rhabdomyosarcoma and soft tissue sarcoma.
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Serum Derived From Patient Donors With Paraneoplastic Pemphigus (PNP) to Be Used as a Positive Control for PNP Test
Rochester, MN
The purpose of this study is to obtain serum from patients with certain rare immunobullous diseases (e.g., paraneoplastic pemphigus, laminin-332 pemphigoid) to replenish a source of positive control for our clinical testing (e.g., Mayo test codes PNPAB, RSBV).
Background:
For various rare immunobullous diseases, detection of a circulating autoantibody is necessary for accurate diagnosis. As a CLIA requirement, every clinical test run requires positive ...
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A Study Of Atezolizumab Alone Or Combined With Immunomodulatory Drug And/or Daratumumab In Multiple Myeloma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL
This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.
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Study Comparing Daratumumab, Lenalidomide, And Dexamethasone With Lenalidomide And Dexamethasone In Participants With Previously Untreated Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).
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A Study Of Belantamab Mafodotin (GSK2857916) In Multiple Myeloma Participants With Normal And Impaired Renal Function
Jacksonville, FL
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions.
Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis.
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Study Of ISB 1342, A CD38/CD3 Bispecific Antibody, In Subjects With Previously Treated Multiple Myeloma
Rochester, MN
The purpose of this study is to determine the safety profile, maximum tolerable dose (MTD) and cohort expansion of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
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A Study Of GC012F (AZD0120), A CAR T Therapy Targeting CD19 And BCMA In Subjects With Relapsed/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
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A Study Designed To Evaluate The Safety And Efficacy Of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) In Participants With T(11;14)-Positive Relapsed Or Refractory Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of venetoclax plus dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex) in participants with t(11;14)-positive Relapsed or Refractory Multiple Myeloma.
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A Study To Evaluate Lenalidomide And Dexamethasone, With Or Without Daratumumab, In Treating High-Risk Smoldering Myeloma Patients
Albert Lea, MN; Eau Claire, WI; Rochester, MN
The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...
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S1211, Bortezomib, Dexamethasone, And Lenalidomide With Or Without Elotuzumab In Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
Jacksonville, FL; Rochester, MN
RATIONALE: Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as elotuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as lenalidomide and dexamethasone also work in different ways to kill tumor cells or stop them from growing. Giving elotuzumab together ...
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American Society Of Hematology Research Collaborative’s Data Hub Multiple Myeloma Program
Rochester, MN
The purpose of this long-term data collection of patients with benign or malignant hematologic diseases is to collect patient demographics, disease characteristics, genomic and molecular data, laboratory data, pathology, radiographic reports, clinical status, quality of life, medications, and dosing information.
The primary goal of the Data Hub is to further the scientific knowledge base for the diagnosis, understanding, and management of benign and malignant hematologic conditions by assembling data collected in routine clinical care and closed clinical trials. Secondary goals are to characterize and study practice patterns for benign and malignant hematologic conditions in clinical practice, and to aggregate patient-reported data to ...
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IDE196 (Darovasertib) In Combination With Crizotinib As First-line Therapy In Metastatic Uveal Melanoma
Rochester, MN
The purpose of this study is to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR), and to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to OS
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Safety And Efficacy Of Bb2121 (Ide-cel) Combinations In Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the safety and effectiveness of bb2121 (Ide-Cel) combinations in subjects with relapsed/refractory multiple myeloma. It also aims to evaluate different agents and their doses/schedules to improve clinical effectiveness in combination with bb2121.
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Appointment Companion Tool
Rochester, MN
The purpose of this study is to pilot the patient appointment companion (PAC) tool in use with patients with amyloidosis and multiple myeloma (MM). Patients with hematologic malignancies have unique information and communication needs compared to those with solid tumors. The internet has shifted the dynamics of the patient–doctor relationship, toward one of more mutual participation whereby power and responsibility are shared. The PAC was designed as a patient-centered, user-friendly platform that aids patients’ preparation for their visits with clinicians. PAC provides an online tool that empowers patients to direct their treatment preferences and care alongside their physician teams per the provisions ...
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Cutaneous Lymphoma Biobank Study
Scottsdale/Phoenix, AZ
The purpose of this study is to create a cutaneous lymphoma tissue repository. This is a highly significant first step in collecting specimens for future analysis to understand the underlying drivers of disease.
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Cutaneous Tissue Using Ex Vivo Fluorescence Confocal Microscopy
Rochester, MN
The purpose of this study, as a proof-of-concept, is to investigate whether ex vivo fluorescence microscopy can provide adequate visualization of cutaneous tissue for determination of non-melanoma skin cancer tumor presence in a sample of up to 250 residual skin specimens.
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A Study To Develop A Cohort Database And Study Platform In Breast Cancer Survivors Using Multiscale Omics
Rochester, MN
The purpose of this study is to develop a breast cancer survivor (BCS) multiscale omics database that includes a complete fecal metagenome (gut microbiome) and fecal metabolome characterization.
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Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
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Vorinostat, Temozolomide, or Bevacizumab in Combination with Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients with Newly Diagnosed High-Grade Glioma
Rochester, MN
This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. ...
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Quality Of Life And Symptomatic Response In Myelofibrosis Patients Receiving An Allogeneic Stem Cell Transplant
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effect your disease and the treatment of allogeneic stem cell transplant has upon you before and after your treatment process through questionnaires at certain time points.
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FORTIFI-HN01: A Study Of Ficerafusp Alfa (BCA101) Or Placebo In Combination With Pembrolizumab In First-Line PD-L1-pos, R Or M HNSCC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
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Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)
No Locations
Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).
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American Society of Hematology Research Collaborative’s Data Hub Multiple Myeloma Program
Rochester, MN
The purpose of this long-term data collection of patients with benign or malignant hematologic diseases is to collect patient demographics, disease characteristics, genomic and molecular data, laboratory data, pathology, radiographic reports, clinical status, quality of life, mediations, and dosing information.
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A Study To Evaluate The Effectiveness And Safety Of Camidanlumab Tesirine (ADCT-301) In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the clinical effectiveness and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
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A Trial Of TTI-621 In Combination With Doxorubicin In Patients With Leiomyosarcoma
Jacksonville, FL
The purpose of this study to evaluate TTI-621 combined with Doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma.
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A Clinical And Molecular Risk-Directed Therapy For Newly Diagnosed Medulloblastoma
No Locations
The purpose of this study is to tailor treatment for medulloblastoma based on molecular distinctions between tumors in order to improve cure rates for molecularly aggressive medulloblastoma, while reducing treatment-related morbidities in survivors of less aggressive medulloblastoma. It is possible that subjects in this study will benefit from a reduction in treatment complications, more effective therapy, and higher rates of survival.
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A Study Comparing Anitocabtagene Autoleucel To Standard Of Care Therapy In Participants With Relapsed/ Refractory Multiple Myeloma (IMMagine-3)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM as measured by progression-free survival (PFS) per blinded independent review committee (IRC).
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Alternate Doses And Dosing Schedules Of Belantamab Mafodotin For The Treatment Of Triple-Class Recurrent And/or Refractory Multiple Myeloma
Jacksonville, FL
The purpose of this study is to assess the 24-week grade 3/4 keratopathy-free rate of an alternative dose/dosing schedule for belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (RRMM).
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A Study In Subjects With Relapsed And Refractory Multiple Myeloma Receiving Carfilzomib In Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing (ARROW)
Scottsdale/Phoenix, AZ
The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
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A Study To Evaluate Triapine Combined With Lutetium Lu 177 Dotatate For Gastroenteropancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.
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Study Evaluating The Safety And Effectiveness Of JCARH125 In Subjects With Relapsed And/or Refractory Multiple Myeloma (EVOLVE)
Rochester, MN
The purpose of this study is to determine the safety and effectiveness of JCARH125 in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.
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Phase II Venetoclax, Obinutuzumab And Bendamustine In High Tumor Burden Follicular Lymphoma As Front Line Therapy
Rochester, MN
Patients with high tumor burden, low grade follicular lymphoma that has never been treated, will receive venetoclax in combination with obinutuzumab and bendamustine. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with follicular lymphoma. Venetoclax may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether adding venetoclax to obinutuzumab and bendamustine improves the response (the tumor shrinks or disappears) in patients with follicular lymphoma.
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A Study Of JNJ-68284528, A Therapy Directed Against B-Cell Maturation Antigen (BCMA) In Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of the study is to characterize the safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the effectiveness of JNJ-68284528 (Phase 2).
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A Study To Develop A Cohort Database And Study Platform In Breast Cancer Survivors Using Multiscale Omics
Rochester, MN
The purpose of this study is to develop a breast cancer survivor (BCS) multiscale omics database that includes a complete fecal metagenome (gut microbiome) and fecal metabolome characterization.
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Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
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A Study of IPI-926 for Patients with Myelofibrosis
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the safety and effectiveness of IPI-926 for the treatment of patients who have myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
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A Biobank for Pancreatic Diseases
Rochester, MN
To develop a resource (bank) of biospecimens and data collected from individuals with pancreatic diseases to facilitate discovery and development of novel biomarkers of risk and early detection, severity prediction, etiology and response to therapy.
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Cytotoxic Activity of Lenalidomide in Combination with the Bispecific CD30/CD16a Therapeutic Monoclonal Antibody, AFM13
Jacksonville, FL
The purpose of this study is to determine whether lenalidomide enhances the activation potential of NK cells derived from Hodgkin’s lymphoma patients. The study also aims to determine if lenalidomide treated NK cells are more efficient in killing CD30+ tumor cells (cancer cell lines) in combination with an investigational agent (AFM13, CD30/CD16a mAb, Affimed Therapeutics, Germany), which engages both the CD30+ tumor cell and CD16a+ NK cells.
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A Study Of Pomalidomide, Ixazomib Citrate, And Dexamethasone In Treating Patients With Previously Treated Multiple Myeloma Or Plasma Cell Leukemia
Rochester, MN
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
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Solitary Bone Plasmacytomas To Elucidate Their Pathogenesis And Risk Of Progression To Multiple Myeloma
Rochester, MN
The purpose of this study is to obtain archived residual formalin-fixed-paraffin-embedded tissue from diagnostic biopsies of solitary bone plasmacytomas for cytogenetic and proteomic testing followed by correlations to their radiographic and clinical features. Clinical, radiographic, and laboratory features of solitary bone plasmacytomas will be evaluated to determine if they can define patients at risk of rapidly progressing to multiple myeloma.
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A Study Comparing CAR-T Therapy Versus Pomalidomide, Bortezomib And Dexamethasone (PVd) Or Daratumumab, Pomalidomide And Dexamethasone (DPd) In Participants With Relapsed And Lenalidomide-Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
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Ivosidenib In Participants With Locally Advanced Or Metastatic Conventional Chondrosarcoma Untreated Or Previously Treated With 1 Systemic Treatment Regimen
Jacksonville, FL; Rochester, MN
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades ...
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Long-Term Study Of Participants Previously With Ciltacabtagene Autoleucel
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to collect data on delayed adverse events after administration of cilta-cel in a previous clinical study, and to characterize and understand the long-term safety profile of cilta-cel.
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Comparing Combinations Of Drugs To Treat Newly Diagnosed Multiple Myeloma (NDMM) When A Stem Cell Transplant Is Not A Medically Suitable Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status.
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Daratumumab Retreatment In Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)
Rochester, MN
The purpose of this study is to compare the effectiveness (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
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Tazemetostat In Combination With Doxorubicin As Frontline Therapy For Advanced Epithelioid Sarcoma
Jacksonville, FL
The purpose of this study is to establish a recommended phase 3 dose (RP3D) and to evaluate the efficacy, PK, and safety of tazemetostat + doxorubicin vs placebo + doxorubicin in subjects with advanced epithelioid sarcoma (ES). This study will be conducted in 2 parts.
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A Study To Evaluate The Effectiveness And Safety Of Bb2121 In Subjects With Relapsed And Refractory Multiple Myeloma And In Subjects With Clinical High-Risk Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effectiveness and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1) and in subjects with HR MM having progressed within one year of initial treatment (Cohort 2). Approximately 122 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2 will enroll approximately 49 MM subjects with 1 prior anti-myeloma treatment regimen and HR disease defined as Stage III by the Revised International Staging System (R-ISS) and early relapse. The cohorts will start in ...
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A Study To Evaluate EAA181 To Treat Newly-diagnosed Multiple Myeloma
La Crosse, WI; Rochester, MN
The primary purpose of this study is to determine if bortezomib, daratumumab, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
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Pazopanib Hydrochloride in Treating Patients with Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma
Jacksonville, FL; Rochester, MN
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
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Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
Rochester, MN
This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.
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Evaluation Of T-RFA And RF-TVA Prior To/Following Radiation Therapy To Treat Painful Metastatic Vertebral Body Tumor(s)
Rochester, MN
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
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Sequential Treatments Or Combinations Including Dasatinib, Quercetin, Fisetin And/or Temozolomide For The Treatment Of Previously Treated Glioma With Residual Disease
Rochester, MN
This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They ...
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Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Rochester, MN
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with ...
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A Study To Assess The Safety And Antitumor Activity Of Genetically Engineered T Cells In NY-ESO-1 And/or LAGE-1a Positive Solid Tumors
Jacksonville, FL; Rochester, MN
To evaluate the effectiveness of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with NY-ESO-1- and/or LAGE-1a positive solid tumors.
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Safety And Efficacy Of ALLO-715 And ALLO-647 BCMA Allogenic CAR T Cells In In Adults With Relapsed Or Refractory Multiple Myeloma (UNIVERSAL)
Rochester, MN
The purpose of this research study is to find out if the experimental treatment, ALLO-715 in combination with ALLO-647, is safe and effective in treating multiple myeloma.
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A Study To Determine Recommended Dose, Regimen And Evaluate The Safety And Preliminary Effectiveness Of CC-92480 In Combination With Standard Treatments In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM) And Newly Diagnosed Multiple Myeloma (NDMM)
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary effectiveness of CC-92480 in combination with standard treatments.
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A Study Of Unesbulin In Participants With Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory Leiomyosarcoma (LMS) who have received at least 1 prior line of systemic therapy.
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A Trial To Find Out If REGN5678 Is Safe And How Well It Works Alone Or In Combination With Cemiplimab For Adult Participants With Metastatic Castration-Resistant Prostate Cancer And Other Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab.
The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.
This study is looking at ...
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A Study To Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant In Participants With Newly Diagnosed Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
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Study Of Lurbinectedin In Combination With Doxorubicin Versus Doxorubicin Alone As First-line Treatment In Participants With Metastatic Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
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Lurbinectedin + Doxorubicin In Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma, and to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.
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Open-Label Study Of The CDK4/6 Inhibitor SPH4336 In Subjects With Locally Advanced Or Metastatic Liposarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug).
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A Study Evaluating Tolerability And Efficacy Of Navitoclax In Combination With Ruxolitinib In Subjects With Myelofibrosis
Jacksonville, FL
This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.
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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients with Myelofibrosis
Scottsdale/Phoenix, AZ
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.
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Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
No Locations
This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
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A Registry Called Every Child for Collecting Data and Biology Specimens on Younger Patients with Cancer
Rochester, MN
The purpose of this registry called Every Child, is to collect data and biospecimens from multiple body sources for younger patients with cancer over time. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
Rochester, MN
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
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A Study To Evaluate The Effectiveness And Safety Of Panzyga In Patients With Chronic Lymphocytic Leukemia
Rochester, MN
The purpose of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in Chronic Lymphocytic Leukemia (CLL) patients with secondary immunodeficiency (SID) undergoing CLL antineoplastic therapy.
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NKX101, Intravenous Allogeneic CAR NK Cells, In Adults With AML Or MDS
Jacksonville, FL
The primary purpose of this study is to assess the safety and tolerability of NKX101 including dose-limiting toxicities (DLTs), and to identify the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of NKX101.
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Lenalidomide Plus Rituximab Followed By Lenalidomide Versus Rituximab Maintenance For Relapsed/Refractory Follicular, Marginal Zone Or Mantle Cell Lymphoma.
Rochester, MN
Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
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A Study Comparing Abemaciclib Plus Temozolomide To Temozolomide Monotherapy In Children And Young Adults With High-grade Glioma Following Radiotherapy
Rochester, MN
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
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Cyclophosphamide, Ixazomib, And Dexamethasone In Treating Patients With Previously Untreated Symptomatic Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I/II trial studies the side effects and the best dose of cyclophosphamide when given together with ixazomib and dexamethasone in treating patients with previously untreated symptomatic multiple myeloma. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib and dexamethasone may be an effective treatment for multiple myeloma.
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Study Of Orally Administered AG-120 In Subjects With Advanced Hematologic Malignancies With An IDH1 Mutation
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Study will not ...
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ALTE07C1, Neuropsychological And Behavioral Testing In Young Patients With Cancer
Rochester, MN
This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer.
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A Study Of Pomalidomide, Ixazomib Citrate, And Dexamethasone In Treating Patients With Previously Treated Multiple Myeloma Or Plasma Cell Leukemia
Rochester, MN
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide, and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
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Daratumumab Retreatment In Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)
Rochester, MN
The purpose of this study is to compare the effectiveness (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
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Tazemetostat In Combination With Doxorubicin As Frontline Therapy For Advanced Epithelioid Sarcoma
Jacksonville, FL
The purpose of this study is to establish a recommended phase 3 dose (RP3D) and to evaluate the efficacy, PK, and safety of tazemetostat + doxorubicin vs placebo + doxorubicin in subjects with advanced epithelioid sarcoma (ES). This study will be conducted in 2 parts.
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Ivosidenib In Participants With Locally Advanced Or Metastatic Conventional Chondrosarcoma Untreated Or Previously Treated With 1 Systemic Treatment Regimen
Jacksonville, FL; Rochester, MN
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades ...
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Solitary Bone Plasmacytomas To Elucidate Their Pathogenesis And Risk Of Progression To Multiple Myeloma
Rochester, MN
The purpose of this study is to obtain archived residual formalin-fixed-paraffin-embedded tissue from diagnostic biopsies of solitary bone plasmacytomas for cytogenetic and proteomic testing followed by correlations to their radiographic and clinical features. Clinical, radiographic, and laboratory features of solitary bone plasmacytomas will be evaluated to determine if they can define patients at risk of rapidly progressing to multiple myeloma.
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A Study Comparing CAR-T Therapy Versus Pomalidomide, Bortezomib And Dexamethasone (PVd) Or Daratumumab, Pomalidomide And Dexamethasone (DPd) In Participants With Relapsed And Lenalidomide-Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to compare the effectiveness of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
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A Study To Evaluate The Effectiveness And Safety Of Bb2121 In Subjects With Relapsed And Refractory Multiple Myeloma And In Subjects With Clinical High-Risk Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effectiveness and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1) and in subjects with HR MM having progressed within one year of initial treatment (Cohort 2). Approximately 122 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2 will enroll approximately 49 MM subjects with 1 prior anti-myeloma treatment regimen and HR disease defined as Stage III by the Revised International Staging System (R-ISS) and early relapse. The cohorts will start in ...
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Long-Term Study Of Participants Previously With Ciltacabtagene Autoleucel
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to collect data on delayed adverse events after administration of cilta-cel in a previous clinical study, and to characterize and understand the long-term safety profile of cilta-cel.
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Comparing Combinations Of Drugs To Treat Newly Diagnosed Multiple Myeloma (NDMM) When A Stem Cell Transplant Is Not A Medically Suitable Treatment
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status.
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A Study To Evaluate EAA181 To Treat Newly-diagnosed Multiple Myeloma
La Crosse, WI; Rochester, MN
The primary purpose of this study is to determine if bortezomib, daratumumab, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
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Pazopanib Hydrochloride in Treating Patients with Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma
Jacksonville, FL; Rochester, MN
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
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Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant
Rochester, MN
This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.
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Evaluation Of T-RFA And RF-TVA Prior To/Following Radiation Therapy To Treat Painful Metastatic Vertebral Body Tumor(s)
Rochester, MN
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
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A Study To Assess The Safety And Antitumor Activity Of Genetically Engineered T Cells In NY-ESO-1 And/or LAGE-1a Positive Solid Tumors
Jacksonville, FL; Rochester, MN
To evaluate the effectiveness of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with NY-ESO-1- and/or LAGE-1a positive solid tumors.
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Safety And Efficacy Of ALLO-715 And ALLO-647 BCMA Allogenic CAR T Cells In In Adults With Relapsed Or Refractory Multiple Myeloma (UNIVERSAL)
Rochester, MN
The purpose of this research study is to find out if the experimental treatment, ALLO-715 in combination with ALLO-647, is safe and effective in treating multiple myeloma.
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Sequential Treatments Or Combinations Including Dasatinib, Quercetin, Fisetin And/or Temozolomide For The Treatment Of Previously Treated Glioma With Residual Disease
Rochester, MN
This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They ...
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Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
Rochester, MN
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with ...
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A Study To Determine Recommended Dose, Regimen And Evaluate The Safety And Preliminary Effectiveness Of CC-92480 In Combination With Standard Treatments In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM) And Newly Diagnosed Multiple Myeloma (NDMM)
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary effectiveness of CC-92480 in combination with standard treatments.
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A Study Of Unesbulin In Participants With Advanced Leiomyosarcoma (LMS)
Jacksonville, FL
The purpose of this study is to compare the effectiveness and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory Leiomyosarcoma (LMS) who have received at least 1 prior line of systemic therapy.
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A Trial To Find Out If REGN5678 Is Safe And How Well It Works Alone Or In Combination With Cemiplimab For Adult Participants With Metastatic Castration-Resistant Prostate Cancer And Other Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab.
The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.
This study is looking at ...
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A Study To Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant In Participants With Newly Diagnosed Multiple Myeloma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
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Study Of Lurbinectedin In Combination With Doxorubicin Versus Doxorubicin Alone As First-line Treatment In Participants With Metastatic Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
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Lurbinectedin + Doxorubicin In Leiomyosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the tolerability of lurbinectedin with doxorubicin in people with soft tissue sarcoma, and to determine which is more effective at treating leiomyosarcoma, lurbinectedin with doxorubicin or lurbinectedin alone.
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Open-Label Study Of The CDK4/6 Inhibitor SPH4336 In Subjects With Locally Advanced Or Metastatic Liposarcomas
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug).
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A Study Evaluating Tolerability And Efficacy Of Navitoclax In Combination With Ruxolitinib In Subjects With Myelofibrosis
Jacksonville, FL
This is a Phase 2, single-arm, open-label, multicenter study evaluating efficacy, safety and tolerability of navitoclax added to ruxolitinib in participants with myelofibrosis.
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A Study of Course and Treatment Outcomes of Paraneoplastic Neurological Disorders and Other CNS Inflammatory Disorders
Rochester, MN
The purpose of this study is to evaluate Mayo patients who have been seropositive for paraneoplastic antibodies with regards to their treatments and symptom progress.
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FT576 in Subjects With Multiple Myeloma
Jacksonville, FL
The purpose of this study is to determine the recommended phase II dose for FT576 when administered as monotherapy and in combination with daratumumab, and to evaluate the safety and tolerability of FT576 when administered as monotherapy and in combination with daratumumab
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Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone ...
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Bendamustine Hydrochloride And Rituximab With Or Without Bortezomib Followed By Rituximab With Or Without Lenalidomide In Treating Patients With High-Risk Stage II, Stage III, Or Stage IV Follicular Lymphoma
Rochester, MN
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and ...
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A Study To Identify Late-Occurring Complications In Childhood Cancer Survivors
Rochester, MN
The purpose of this trial is to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.
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Brentuximab Vedotin And Nivolumab With Or Without Ipilimumab In Treating Patients With Relapsed Or Refractory Hodgkin Lymphoma
Rochester, MN
This phase I trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. Giving ipilimumab or nivolumab or both with ...
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A Study Of Effect Of Different Biochemical Markers Including Leptin And Spexin In Children Before And After Having Hypothalamus Surgery
Rochester, MN
The purpose of this study is to learn more about the changes in levels of Spexin, leptin and other biomarkers such as adiponectin and resting energy expenditure before and after hypothalamic surgery.
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Study Of ORIC-533 In Relapsed Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
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Perceived Financial Hardship In Patients With Multiple Myeloma And Their Caregivers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of the study is to examine the agrrement in perception of finacial hardship (FH) and the perceived stress in patients with multiple myeloma (MM) and their caregivers (CG). Additionally, we will describe protective buffering/emotional disclosure in patients with MM and their CGs and examine their association with FH, and perceived stress.
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Study Of Intralesional Cemiplimab In Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ
This study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called programmed cell death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.
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A Study To Assess The Safety And Tolerability Of CFT8634 In Locally Advanced Or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma And SMARCB1-Null Tumors
Jacksonville, FL; Rochester, MN
The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.
Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.
Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).
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Rem-422, An MYB MRNA Degrader, In Patients With Relapsed/Refractory AML Or Higher-Risk MDS
Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability of REM-422 in patients with relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes.
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A Study Evaluating The Efficacy And Safety Of Cevostamab In Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma (CAMMA 2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the effiectiveness, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of cevostamab, a humanized, full-length IgG1 T-cell-dependent bispecific (TDB) antibody, in participants with multiple myeloma (MM).
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Study Of ADI-PEG 20 Or Placebo Plus Gem And Doc In Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
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Abemaciclib Versus Placebo In Patients With Advanced Dedifferentiated Liposarcoma
Jacksonville, FL
The purpose of this study is to evaluate abemaciclib versus placebo to treat Advanced Dedifferentiated Liposarcoma. Patients with progression of disease will cross over to open label abemaciclib.
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CC-220-MM-001: A Phase 1b/2a Multicenter, Open-Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Assess The Safety, Tolerability, Pharmacokinetics And Efficacy Of CC-220 As Monotherapy And In Combination With Other Treatments In Subjects With Multiple Myeloma
Scottsdale/Phoenix, AZ
This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to determine the maximum tolerated dose of CC-220 when administered as monotherapy and in combination with dexamethasone. The study will consist of an escalating dose-escalation portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT) and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).
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A Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of HPN217 In Patients With Relaped/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate HPN217 as monotherapy to assess the safety, tolerability and pharmacokinetics in patients with relapsed/ refractory multiple myeloma.
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A Study Of TNB-383B In Subjects With Relapsed Or Refractory Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the safety, clinical pharmacology and clinical activity of TNB-383B, a T-cell engaging bispecific antibody, in subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B ranging from 25 micrograms to 40 milligrams per dose, administered once every 3 weeks (Q3W), in approximately 24 subjects. Once the maximum tolerated dose (MTD) or ...
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Bone Health in Patients with/without Adrenal Disease
Rochester, MN
The purpose of this study is to determine prevalence and incidence of osteopenia, osteoporosis, and fractures in patients with adenomas based on hormonal sub-type, and to determine the effect of abnormal steroid metabolome on bone density, bone metabolism, and fractures.
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Study To Evaluate Mechanisms Of Immunomodulator Sensitivity And Resistance In Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine response rates (>=PR) of prospectively treated MM patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.
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A Safety Study Of SEA-TGT (SGN-TGT) In Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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GPRC5D-directed CAR T Cell Therapy In Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT.
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A Study Of Daratumumab, Bortezomib, Lenalidomide And Dexamethasone (DVRd) Followed By Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide And Dexamethasone (DVRd) Followed By Autologous Stem Cell Transplant (ASCT) In Participants With Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
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A Study Of CLN-619 (Anti-MICA/MICB Antibody) In Patients With Relapsed And Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma.
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A Study To Evaluate The Efficacy And Safety Of Golcadomide In Combination With Rituximab In Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
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Idasanutlin, Ixazomib Citrate, And Dexamethasone In Treating Patients With Relapsed Multiple Myeloma
Jacksonville, FL; Rochester, MN
Does idasanutlin in combination with ixazomib and dexamethasone contribute to better outcomes for patients with multiple myeloma who have been previously treated for their disease?
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Cisplatin And Etoposide Or Temozolomide And Capecitabine In Treating Patients With Neuroendocrine Carcinoma Of The Gastrointestinal Tract Or Pancreas That Is Metastatic Or Cannot Be Removed By Surgery
Rochester, MN
This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current ...
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A Study To Evaluate The Safety, Tolerance And Anti-tumor Activity Of SAR442257 In Patients With Relapsed/Refractory Multiple Myeloma And Relapsed/Refractory Non-Hodgkin Lymphoma
Rochester, MN
The primary purpose of this study is to determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D).
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Bone Health in Patients with/without Adrenal Disease
Rochester, MN
The purpose of this study is to determine prevalence and incidence of osteopenia, osteoporosis, and fractures in patients with adenomas based on hormonal sub-type, and to determine the effect of abnormal steroid metabolome on bone density, bone metabolism, and fractures.
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Study To Evaluate Mechanisms Of Immunomodulator Sensitivity And Resistance In Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine response rates (>=PR) of prospectively treated MM patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.
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A Safety Study Of SEA-TGT (SGN-TGT) In Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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GPRC5D-directed CAR T Cell Therapy In Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT.
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A Study Of Daratumumab, Bortezomib, Lenalidomide And Dexamethasone (DVRd) Followed By Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide And Dexamethasone (DVRd) Followed By Autologous Stem Cell Transplant (ASCT) In Participants With Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
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A Study Of CLN-619 (Anti-MICA/MICB Antibody) In Patients With Relapsed And Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma.
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SX-682 Treatment In Subjects With Myelodysplastic Syndrome Who Had Disease Progression Or Are Intolerant To Prior Therapy
Jacksonville, FL
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
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Dinutuximab With Chemotherapy, Surgery And Stem Cell Transplantation For The Treatment Of Children With Newly Diagnosed High Risk Neuroblastoma
Rochester, MN
The purpose of this stduy tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing ...
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Manufacturing Outcomes With Patient Factors From Multiple Myeloma Patients Prescribed Ciltacabtagene Autoleucel
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to identify patient factors that are associated with low-viability or low-dose out-of specification (OOS) in ciltacabtagene autoleucel drug product (DP).
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A Study To Learn About The Study Medicine (Elranatamab) In Participants With Multiple Myeloma That Has Come Back After Responding To Treatment Or Has Not Responded To Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and effectiveness of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every ...
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A Study Of CTX-712 In Relapsed/Refractory Acute Myeloid Leukemia And Higher Risk Myelodysplastic Syndromes
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of Phase I of this study is to evaluate the safety and tolerability of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) / higher risk myelodysplastic syndromes (HR-MDS) / MDS/MPN to determine the recommended dose of CTX-712. The purpose of Phase II of this study is to assess the effiectiveness of CTX-712 in patients with R/R AML/HR-MDS by determination of complete remission (CR) rates.
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Localized Leiomyosarcoma Biomarker Protocol
Rochester, MN
The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].
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NBTXR3 With Or Without Cetuximab LA-HNSCC
Jacksonville, FL
The purpose of this study is to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.
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A Trial To Assess Effectiveness And Safety Of Octreotide Subcutaneous Depot In Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Vaccine (PDS0101) Alone Or In Combination With Pembrolizumab For The Treatment Of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Rochester, MN
Some patients with head and neck cancer caused by human papilloma virus have a higher risk of recurrence. We are proposing to treat these patients with HPV vaccine with or without pembrolizumab during the window prior to surgery, in hopes of stimulating an immune response.
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A Study Of JNJ-68284528, A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) In Participants With Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
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A Study To Determine The Effect Of Distance Reiki On Patient Reported Quality Of Life (PRQoL) And Immunity Among Multiple Myeloma Patients
Rochester, MN
This study aims to demonstrate acceptability and feasibility of the use of Distance Reiki therapy versus sham Reiki therapy among multiple myeloma patients.It also aims to determine if there is a minimal clinically meaningful improvement in various QOL domains (Physical, Social, Emotional), overall QOL with use of Patient-Reported Outcomes Measurement Information System (PROMIS-29) and Single Item Linear Analogue Scale (LASA) after Distance Reik. Lastly, it aims to analyze the effect of Distance Reiki on expansion of the immune repertoire by comparing immune repertoires at baseline and at the end of the study by using Mass spectrometry by CyTOF® and multiplex ...
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Study Assessing Activity Of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies In Adult Participants With Relapsed Or Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine change in disease symptoms of ABBV-383 compared to standard available therapies in adult participants with Relapsed or Refractory Multiple Myeloma. ABBV-383 is an investigational drug being developed for the treatment of Relapsed or Refractory Multiple Myeloma.
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A Quality of Life Assessment of Patients with Biliary Obstruction Undergoing Endoscopic or Percutaneous Drainage
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The aim of this study is to compare the quality of life of patients with biliary obstruction who have undergone an endoscopic or percutaneous drainage. The quality of life of patients witll be assessed using the validated "European Quality of Life-5 Dimensions Questionnaire" and the "Intervention-Dependent Questionnaire" which was developed according to current literature as well as the expert opinion of gastroeneterologists.
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Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Rochester, MN
RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss.
PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
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Outcomes For Hand And Foot Soft Tissue Sarcomas Treated With Limb Sparing Multimodal Therapy
Rochester, MN
Goals:
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Report and describe patient-reported functional outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.
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Describe radiotherapy volumes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.
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Report local control outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.
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Report survival outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.
...
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LS138D, Rituximab With Or Without Yttrium Y-90 Ibritumomab Tiuxetan In Treating Patients With Untreated Follicular Lymphoma
Rochester, MN
This randomized phase III trial studies rituximab and yttrium Y-90 ibritumomab tiuxetan to see how well they work compared to rituximab alone in treating patients with untreated follicular lymphoma. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Radioactive substances linked to monoclonal antibodies can bind to cancer cells and give off radiation which may help kill cancer cells. It is not yet known whether rituximab is more effective with or without yttrium Y-90 ibritumomab tiuxetan in treating follicular lymphoma.
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Collection Of Primary Retroperitoneal Sarcoma Data, Radiological, And Pathological Material For The Transatlantic Australasian Retroperitoneal Sarcoma Working Group
Jacksonville, FL
The purpose of this study is to prospectively collect standardized clinical data and radiological and pathological material from primary retroperitoneal sarcomas RPS patients treated with surgery at reference centers. Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).
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Methylation And Chromatin Abnormalities In Myelodysplastic Syndromes And Chronic Myelomonocytic Leukemia.
Rochester, MN
The purpose of this study is to assess tumor cells from blood and bone marrow from patients with myeloid neoplasms for epigenetic dysregulation and abnormalities of chromatin and for immune activation and exhaustion.
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Phase 3 Frontline Therapy Trial In Patients With Advanced Classical Hodgkin Lymphoma
Rochester, MN
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
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Efficacy And Safety Study Of Bb2121 In Subjects With Relapsed And Refractory Multiple Myeloma (KarMMa)
Rochester, MN
This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
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A Registry For Children Treated With Proton Radiation Therapy
Rochester, MN
The purpose of the Pediatric Proton Consortium Registry (PPCR) is to enroll children who have been treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data which many centers that deliver proton radiation therapy already collect in routine operations.
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A Study To Evaluate Myeloma-Developing Regimens Using Genomics (MyDRUG)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of ...
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Romidepsin in Treating Patients with Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors with Liver Dysfunction
Rochester, MN
This phase I trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction. Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking the activity of proteins that are important for the cancer's growth and survival.
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Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
Scottsdale/Phoenix, AZ
Phase I Dose Escalation: To investigate the MTD, safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in patients ≥ 65 years of age with newly diagnosed previously untreated AML, relapsed or refractory AML or high risk MDS, and considered ineligible for standard intensive therapy. Phase I MTD Extension: To collect additional data on safety, efficacy and pharmacokinetics and to confirm the Recommended Phase II Dose (RP2D), of volasertib in combination with decitabine in previously untreated patients with AML ≥ 65 years of age and considered ineligible for standard intensive therapy. Phase IIa: Efficacy of volasertib in combination with ...
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A Study To Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed And/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
Rochester, MN
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
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Sarcopenia Impact Among Older Patients With Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the association between baseline sarcopenia and high-grade chemotherapy toxicity during the first 4 cycles of treatment measured by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0, the Patient-Reported Outcomes (PRO) version of the CTCAE(PRO-CTCAE), and treatment discontinuation in older patients (≥60 years) with hematologic malignancies.
The hypothesis is that for older patients with hematologic malignanclies, sarcopenia is associated with higher likelihood of high-grade treatment-related chemotherapy toxicity and a higher rate of treatment discontinuation during the first 4 cycles of treatment.
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BCL2 Inhibitor Venetoclax With Daratumumab-Lenalidomide-Dexamethasone Or Venetoclax-Rd For Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to estimate the recommended phase II dose (RP2D) of venetoclax that can be combined with standard dose Dd combination (Arm A), Rd combination (Arm B) or daratumumab, lenalidomide and dexamethasone (Arm C) in patients with newly diagnosed t(11;14) multiple myeloma (MM).
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A Study To Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.
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A Study To Evaluate APG2575 Combined With Novel Therapeutic Regimens To Treat Subjects With Relapsed Or Refractory Multiple Myeloma And Immunoglobulin Light Chain Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).
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A Study To Compare Early Use Of Vinorelbine And Maintenance Therapy For Patients With High Risk Rhabdomyosarcoma
Rochester, MN
This phase III trial compares the effect of vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide for the treatment of high risk rhabdomyosarcoma. Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vinorelbine and VAC may kill more tumor cells. Adding maintenance therapy (vinorelbine and cyclophosphamide) after VAC therapy, with or without vinorelbine, may help get rid of the cancer and/or ...
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The Impact Of A Geriatric Assessment In Elderly Patients With Multiple Myeloma
Rochester, MN
The purpose of this study is to evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (≥ 65 years) with multiple myeloma (MM).
Multiple myeloma (MM) is a blood cancer that affects a type of white cell called plasma cell. It mainly affects older individuals and has an average age at diagnosis of 69 years.
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A Study Of How Current Treatments Impact The Course Of Relapsed Myeloma And The Effect Of The Treatments On The Quality-of-life Measurements.
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to determine the impact of standard of care therapies for TCR MM, in a real-world setting, on patient-reported symptoms, functioning, and QoL, measured prospectively using questionnaires. The secondary goal is to asses clinical endopoints associated with standard of care therapies for TCR MM, in a real-world setting during 12 months of observation.
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A Study To Compare Nivolumab Or Brentuximab Vedotin Plus Combination Chemotherapy To Treat Patients With Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...
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Bortezomib Or Carfilzomib With Lenalidomide And Dexamethasone In Treating Patients With Newly Diagnosed Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer cells
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First In Human (FIH) Study Of REGN5459 In Patients With Relapsed Or Refractory Multiple Myeloma (MM)
Rochester, MN
The purpose of this study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) (defined as either a maximum tolerated dose regimen [MTDR] or biologically effective dose regimen [BEDR]) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit.
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A Study To Examine The Effects Of Novel Therapy Linvoseltamab In Combination With Other Cancer Treatments For Adult Patients With Multiple Myeloma That Is Resistant To Current Standard Of Care Treatments
Rochester, MN
This phase 1b trial is an open-label study designed to assess the safety, tolerability, and preliminary antitumor activity of REGN5458 in combination with other cancer treatments for patients with relapsed/refractory multiple myeloma (RRMM).
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Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, And Nivolumab In Treating Patients With Stage I-II Hodgkin Lymphoma
Rochester, MN
This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab ...
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A Study to Evaluate The Use of Intravenous Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery for Vestibular Schwannomas (VS)
Rochester, MN
The purpose of this study is to evaluate the benefit of using intravenous fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery for vestibular schwannomas (VS), Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma and to determine the optimum FS dose and timing to be used with the YE560 device.
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A Study to Develop and Validate a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma
Rochester, MN
The purpose of this study is to develop and validate a new disease-specific, quality-of-life (QOL) index for sporadic Vestibular Schwannoma (VS) that addresses key shortcomings of previous instruments.
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A Study To Examine The Effects Of Novel Therapy Linvoseltamab In Combination With Other Cancer Treatments For Adult Patients With Multiple Myeloma That Is Resistant To Current Standard Of Care Treatments
Rochester, MN
This phase 1b trial is an open-label study designed to assess the safety, tolerability, and preliminary antitumor activity of REGN5458 in combination with other cancer treatments for patients with relapsed/refractory multiple myeloma (RRMM).
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Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, And Nivolumab In Treating Patients With Stage I-II Hodgkin Lymphoma
Rochester, MN
This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab ...
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BCL2 Inhibitor Venetoclax With Daratumumab-Lenalidomide-Dexamethasone Or Venetoclax-Rd For Newly Diagnosed Multiple Myeloma
Rochester, MN
The purpose of this study is to estimate the recommended phase II dose (RP2D) of venetoclax that can be combined with standard dose Dd combination (Arm A), Rd combination (Arm B) or daratumumab, lenalidomide and dexamethasone (Arm C) in patients with newly diagnosed t(11;14) multiple myeloma (MM).
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A Study To Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.
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A Study To Compare Nivolumab Or Brentuximab Vedotin Plus Combination Chemotherapy To Treat Patients With Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma
Eau Claire, WI; Rochester, MN
The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...
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Bortezomib Or Carfilzomib With Lenalidomide And Dexamethasone In Treating Patients With Newly Diagnosed Multiple Myeloma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well it works compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib or carfilzomib together with lenalidomide and dexamethasone may kill more cancer cells
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Oral Tamoxifen Vs. TamGel Vs. Control In Women With Atypical Hyperplasia Or Lobular Carcinoma In Situ
Rochester, MN
The purpose of this study is to analyze breast tissue changes after a short course of Tamoxifen (Tam).
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Study Of Tirabrutinib Vs Rituximab/Temozolomide For Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
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Ascorbic Acid And Chemotherapy For The Treatment Of Relapsed Or Refractory Lymphoma, CCUS, And Chronic Myelomonocytic Leukemia
Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may kill more cancer cells.
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A Study To Measure The Proteins Expressed In Tissue Samples From Women Who Have Been Treated With New Endocrine Therapy For Invasive Lobular Breast Cancer
Rochester, MN
The purpose of this study is to compare the effectiveness of fulvestrant to anastrozole or tamoxifen in treating invasive lobular breast cancer, by measuring the level of the biomarker Ki67 found in tumor tissue before and then after treatment.
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XmAb18968 (CD3-CD38) In Relapsed Or Refractory Acute Leukemia And T Cell Lymphoblastic Leukemia
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).
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A Study of Using Bortezomib and Combination Chemotherapy in Treating Children with Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Rochester, MN
This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
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Molecular Breast Imaging in Women with Atypia and LCIS
Rochester, MN
We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.
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Undiagnosed Tumor/Undifferentiated Mass Registry
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to create a research registry to prospectively collect research biospecimens and corresponding clinical data from subjects with an undiagnosed tumor or undifferentiated mass.
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DALY 2.0 USA/ MB-CART2019.1 For DLBCL
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the effectiveness of MB-CART2019.1 cells administered following a conditioning lymphodepletion regimen in diffuse large B cell lymphoma (DLBCL) subjects who failed at least two lines of therapy as measured by objective response rate (ORR) at one month.
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A Study of the Incidence and Prevalence of Oral Squamous Cell Carcinoma in Patients with Oral Lichen Planus in Olmsted County from 1986-2010.
Rochester, MN
The purpose of this study is to assess the incidence and prevalence of oral squamous cell cancer in patients with oral lichen planus in Olmsted County 1986-2010.
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Cardiotoxic Effects Of Chemotherapy In Patients With Sarcomas
Rochester, MN
The purpose of this study is to determine if two-dimensional speckle tracking echocardiography (2D-STE) derived-strain can detect early myocardial dysfunction and thus predict cardiotoxicity in sarcoma subjects undergoing anthracycline therapy and to compare three dimensional speckle tracking echocardiography (3D-STE) to 2D-STE in the same group of patients.
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A Study To Assess The Safety And Tolerability Of CFT7455 In Relapsed/Refractory Non-Hodgkin's Lymphoma Or Multiple Myeloma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of CFT7455 administered orally in subjects with Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM) administered once a day (QD) as a single agent and in combination with dexamethasone.
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E6201 Plus Dabrafenib For The Treatment Of Metastatic Melanoma Central Nervous System Metastases (CNS)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.
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Investigating Magnesium Glycinate In Structure/Function Role Of Hot Flashes.
Jacksonville, FL
The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.
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AKT Inhibitor MK2206, Combined with Bendamustine Hydrochloride, and Rituximab for Treating Patients who have Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
The purpose of this study is is to assess the side effects and best dose of akt inhibitor MK2206 when given together with bendamustine hydrochloride and rituximab, and to see how well they work in treating patients with treatment resistant chronic lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, ...
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Establishment of a Human Thyroid Tissue and Blood Sample Repository
Rochester, MN
The purpose of this study is to establish a human biobank of thyroid-derived tissues and blood samples from patients with thyroid disorders at Mayo Clinic in Rochester.
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Extracorporeal Photopheresis And Mogamulizumab For The Treatment Of Erythrodermic Cutaneous T Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effect of extracorporeal photopheresis (ECP) and mogamulizumab in treating patients with erythrodermic cutaneous T cell lymphoma (CTCL), a type of skin lymphoma.
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MC230813 A Study Of Golcadomide With Rituximab Prior To CAR-T With Relapsed Or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL)
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate efficacy as measured by the disease control rate (CMR, PMR, and NMR) by Lugano 2014 PET-CT based assessment after 2 cycles of therapy.
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Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy In HER2-positive Breast Cancer Patients
Rochester, MN
The purpose of this study is to prospectively evaluate the patient-reported outcomes data of T-DM1 induced peripheral neuropathy like prior research focused on paclitaxel-, paclitaxel/CBDCA-, oxaliplatin-, and cisplatin-induced peripheral neuropathy, to better understand the similarities and differences of chemotherapy-induced peripheral neuropathy (CIPN) symptoms caused by different agents, their pathogenesis, and impacts.
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A Study of Immune Profiling of Blood Samples in Patients with Benign and Malignant Thyroid Disorders
Rochester, MN
The purpose of this study is to perform a comprehensive immunophenotypic analysis of peripheral bloods samples from patients with benign and malignant thyroid disease. This data will be used to determine whether patients with advanced thyroid cancers have significantly altered numbers and/or subtypes of circulating immune cells, in particular immunosuppressive monocytes.
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A Study of Using Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Rochester, MN
This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.
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A Study to Optimize Patient Selection and Outcomes in Laryngeal Vascular Composite Allograft Transplantation
Scottsdale/Phoenix, AZ
In-depth qualitative interviews will be performed to explore beliefs of laryngotracheal transplant candidates, their caregivers, and clinicians about their perceptions and experience of the laryngotracheal transplantation process. In addition, we will explore the quality of life of patients with a laryngectomy.
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Phase 2 Study With TTI-622 And TTI-621 In Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, MN
The purpose of ths study is to find out more about the side effects of two new drug combinations for lymphoma, TTI-621 and pembrolizumab and TTI-622 and pembrolizumab, and what doses of TTI-621 and TTI-622 are safe for people to take. In addition, we want to learn if the drug combinations help your cancer.
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A Phase 3 Study To Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy In Previously Treated Head And Neck Squamous Cell Carcinoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
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Radiation Therapy With Or Without Chemotherapy In Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Rochester, MN
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
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A Study Of Proton Versus Photon Beam Radiotherapy In The Treatment Of Unilateral Head And Neck Cancer
Rochester, MN
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.
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Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
No Locations
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the signaling molecules needed for cell growth. Monoclonal antibodies, such as alemtuzumab, can bind to and kill malignant lymphocytes.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with alemtuzumab and will see how well they work in treating patients with recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL).
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The Mayo Clinic Breast Disease Survivors Study
Rochester, MN
This study will recruit breast cancer patients and survivors to take part in an ongoing study of the issues and concerns surrounding breast cancer survivorship. We will recruit both newly diagnosed patients as well as patients diagnosed within the past 5 years. Those who consent to the study will be asked to provide a series of questionnaires and blood samples over time. These data/samples will create a repository that will enable us to address many specific hypotheses both now and in the future. As part of the study DNA samples will be genotyped for common genetic variants ...
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Wild-Type Reovirus In Combination With Sargramostim In Treating Younger Patients With High-Grade Relapsed Or Refractory Brain Tumors
Rochester, MN
This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.
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A Study To Evaluate PDS0101 And Pembrolizumab Combination To Treat Subjects With HPV16 + Recurrent And/or Metastatic Head And Neck Squamous Cell Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of PDS0101 administered in combination with Pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
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A Trial To Evaluate The Efficacy And Safety Of MOR208 With Bendamustine (BEN) Versus Rituximab (RTX) With BEN In Adult Patients With Relapsed Or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of this research study is to compare the effects and safety of the study drug, MOR00208, given with bendamustine (BEN) to another treatment combination, rituximab (RTX) in combination with BEN to find out which combination is better for treating DLBCL. MOR00208 is an investigational drug. RTX and BEN are both approved in many countries for the treatment of lymphomas. The combination of both is considered and recommended by some medical authorities in some other countries as an option to treat DLBCL.
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A Study Evaluating The Effectiveness Of Axicabtagene Ciloleucel Compared To Standard Of Care Therapy In Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by event-free survival (EFS), as determined by blinded central review.
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A Study of Aplidin for Treating Patients with Primary Myelofibrosis, Post Polycythemia Vera or Essential Thrombocythemia Myelofibrosis
Rochester, MN
The purpose of this study is to assess the safety and effectiveness of Aplidin® (plitidepsin) for the treatment of Patients who have primary myelofibrosis and post polycythemia vera/essential thrombocythemia myelofibrosis.
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A Phase 1 Study Of Voruciclib In Subjects With B-Cell Malignancies Or AML
Rochester, MN
The purpose of this study is to determine the safety and preliminary efficacy of voruciclib as monotherapy in subjects with relapsed or refractory B-cell malignancies or AML, and in combination with venetoclax in subjects with relapsed or refractory AML after treatment with standard therapy.
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Pirtobrutinib And Venetoclax With MRD Detection For Previously Untreated Chronic Lymphocytic Leukemia
Rochester, MN
This phase II trial studies how well pirtobrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. This study also seeks to adopt a blood test which shows a small number of cancer cells in the body after cancer treatment called minimal residual disease as a guide to determine length of treatment. Drugs used in chemotherapy, such as pirtobrutinib and venetoclax, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Identifying minimal residual disease results after combination chemotherapy may help guide future ...
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GEN3013, Epcoritamab Trial In Patients With Relapsed, Progressive Or Refractory B-Cell Lymphoma EPCORE™ NHL-1
Scottsdale/Phoenix, AZ
The purpose of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose as well as to establish the safety profile of GEN3013 (DuoBody®-CD3xCD20) in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.
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A Phase 1 Dose Escalation And Expansion Study Of TGR-1202 + Ruxolitinib In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (PPV-MF), Post-Essential Thrombocythemia MF (PET-MF), MDS/MPN, Or Polycythemia Vera Resistant To Hydroxyurea
Scottsdale/Phoenix, AZ
This is a Phase 1, open-label, study of TGR-1202, a PI3K delta inhibitor, administered together with ruxolitinib in patients with myeloproliferative neoplasms (specifically: polycythemia vera, primary myelofibrosis, PPV-MF or PET-MF) and MDS/MPN.
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Lenalidomide And Low-Dose Dexamethasone In Patients With Previously Treated Multiple Myeloma And Kidney Dysfunction
Scottsdale/Phoenix, AZ; Rochester, MN
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used ...
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Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.
PURPOSE: ...
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Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is determine objective response rate (ORR) by RECIST 1.1 by blinded independent central review (BICR) of envafolimab (cohort A), and of envafolimab combined with ipilimumab at 1 mg/kg (cohort B), in separate cohorts of patients with locally advanced, unresectable or metastatic UPS/MFS that has progressed following one or two lines of chemotherapy, without a formal statistical comparison between the two cohorts.
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Metastatic Tumor Research And Outcomes Network
Rochester, MN
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
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PEA For The Relief Of Chemotherapy-Induced Peripheral Neuropathy
Eau Claire, WI; Rochester, MN
The purpose of this study the efectiveness of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN). Also, to assess the safety of PEA at the two study doses, and to evaluate changes in patient-reported symptoms and quality of life from baseline to the end of 8 weeks.
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A Study To Determine The Outcomes Of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy
Rochester, MN
AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS). Risk stratification will be determined by traditional prognosticators (tumor genetics, extent of extramedullary involvement, early response to therapy as determined by flow cytometry) combined with the new DNA-based MRD detection technology of high throughput sequencing (HTS) of the immunoglobulin heavy chain (IgH).
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Epcoritamab Compared To Observation For Treating B-cell Lymphoma Patients Not In Complete Remission After CD19-directed CAR-T Therapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy.
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Phase 1 Trial To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of Splicing Modulator H3B-8800 For Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, And Chronic Myelomonocytic Leukemia
Jacksonville, FL; Rochester, MN
This study will include a Phase 1 dose-finding portion (Cohorts A and B) and a four-arm expansion portion. The primary objectives of the study are to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-8800 administered orally in participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML) and to assess the safety and tolerability of H3B-8800 as a single agent administered orally once daily on a 5 days on/9 days off repeated dosing schedule in 28-day cycles in participants with MDS, AML, or CMML.
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Metagenomic Shotgun Sequencing of Blood to Identify Pathogens in Patients with Neutropenic Fever
Rochester, MN
The purpose of this study is to determine whether metagenomic shotgun sequencing can identify microorganisms present in blood sample of patients with febrile neutropenia.
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Genetic Epidemiology of Glioma-International Consortium
Rochester, MN
The purpose of this study is to identify common genetic variants contributing to the risk of glioma. Evaluate gene-gene and gene-environmental interactions with strong biologic relevance to identify gene-gene and gene-environment interactions for glioma risk.
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A Study To Explore If It Is Possible To Successfully Obtain Optical Coherence Tomography (OCT) Imaging And Data While Patients Undergo Brain Surgery
Jacksonville, FL
The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.
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Financial Difficulty In Patients With Blood Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to analyze the financial difficulties experienced by patients undergoing treatment for multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). It is composed of a patient survey (n=250), a physician survey (n=100), and a practice survey completed by each site enrolling patients onto this study. A subset of enrolled patients (n=35) will be invited to participate in an optional second telephone interview (Appendix D). This study will measure the prevalence of patient-reported financial difficulty, specific financial burdens and resources currently available to patients and from practices to assist with patient financial navigation.
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(Peak) A Phase 3 Randomized Trial Of CGT9486+Sunitinib Vs. Sunitinib In Subjects With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare CGT9486 in combination with sunitinib to treat gastrointestinal stromal tumors.
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A Study Of DCC-2618 Vs. Sunitinib In Advanced GIST Patients After Treatment With Imatinib
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
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Testing Whether High Dose Chemotherapy And Infusion Of The Patients' Own Stem Cells Improves Survival In Patients With Peripheral T-cell Lymphoma Who Achieved A Complete Response At The End Of The Initial Chemotherapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior ...
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A Study To Investigate The Effects Of GC4419 On Radiation-Induced Oral Mucositis In Patients With Head/Neck Cancer
Jacksonville, FL
The purpose of this study is to determine if GC4419, administered prior to intensity-modulated radiation therapy (IMRT), reduces the severity of radiation-induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
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Novel Total Body Photography System For Accessible And Accurate Skin Cancer Screening
Rochester, MN
The overall goal of this pilot study is to assess initial quality and feasibility of a novel protoype TBP system that may be used in the future for accurate and accessible skin cancer screening called Skinmap. Skinmap’s automatic anatomical registration will be sufficient to permit accurate alignment of baseline overlays on current imagery for visual and automated detection of changes 1mm or greater on 95% of exposed skin in baseline and current image sets. The teams of Triangulate Labs and Mayo Clinic Enterprise Dermatology propose to validate, refine, and explore the clinical utility of Skinmap.
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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Jacksonville, FL
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
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A Study Of ABBV-383 With Relapsed Refractory Waldenström Macroglobulinemia
Rochester, MN
The purpose of this study is to determine the safety, maximum tolerated dose (MTD) and RP2D of ABBV-383 monotherapy for patients with RRWM and to determine VGPR or deeper response as the best response achieved with ABBV 383 within 12 cycles of initiation of therapy for patients with RRWM.
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Apixaban In Preventing Secondary Cancer Related Blood Clots In Cancer Patients Who Have Completed Anticoagulation Therapy
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related blood clots in cancer patients who have completed anticoagulation therapy. Apixaban may stop the clotting of blood by blocking some of the enzymes needed for blood clotting.
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A Study To Evaluate The Effect Of Ripretinib On The Pharmacokinetics Of A CYP2C8 Probe Substrate In Patients With Advanced GIST
Jacksonville, FL
The purpose of this study is to evaluate the effect of Ripretinib on the pharmacokinetics of a CYP2C8 Substrate.
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A Study To Compare Three Chemotherapy Regimens For The Treatment Of Patients With Newly- Diagnosed Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib, and to determine how well they work in treating patients with newly-diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the ...
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A Study Of THE-630 In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Jacksonville, FL
The purpose of this study is to assess the safety, effectiveness, and pharmacokinetics of THE-630 in participants with advanced gastrointestinal stromal tumors (GIST).
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A Study Comparing Ibrutinib And Obinutuzumab With Or Without Venetoclax In Treating Patients With Chronic Lymphocytic Leukemia
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this trial is to evaluate how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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Duvelisib And Nivolumab For The Treatment Of Stage IIB-IVB Mycosis Fungoides And Sezary Syndrome
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in ...
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Axicabtagene Ciloleucel Expanded Access Study
Rochester, MN
A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma.
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Nilotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Scottsdale/Phoenix, AZ; Rochester, MN
In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all the ways that this drug may affect people
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Testing The Addition Of A New Drug, Venetoclax, To The Usual Treatment (Ibrutinib And Rituximab) For Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effects of ibrutinib and rituximab with or without venetoclax in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax with ibrutinib and rituximab with may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ...
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Ibrutinib In Treating Patients With Relapsed Hairy Cell Leukemia
Rochester, MN
This phase II trial studies how well ibrutinib works in treating patients with relapsed hairy cell leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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MYELOMATCH: A Screening Study To Assign People With Myeloid Cancer To A Treatment Study Or Standard Of Care Treatment Within MyeloMATCH (MyeloMATCH Screening Trial)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how ...
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Extracellular Impact Of Ultrasound-induced Blood-brain Barrier Disruption
Rochester, MN
The purpose of this study is to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment.
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A Study Of Lower Radiotherapy Dose To Treat Children With CNS Germinoma
Rochester, MN
The purpose of this study is to determine how well lower dose radiotherapy after chemotherapy (Carboplatin & Etoposide) works in treating children with central nervous system (CNS) germinomas.
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A Study Of CG-806 In Patients With Relapsed Or Refractory CLL/SLL Or Non-Hodgkin's Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability and effectiveness of CG-806 for the treatment of patients with the condition of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.
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A Phase 1/2 Study Of CYT-0851 In B-Cell Malignancies And Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.
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A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
Rochester, MN
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...
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A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.
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STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)
Rochester, MN
The purpose of this study is to verify the gene array data by examining the protein expression in brain tissue of diffuse intrinsic pontine glioma (DIPG) patients compared to normal healthy subjects using western blot.
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Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well combination chemotherapy and pralatrexate works in treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
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A Study To Evaluate VSV-hIFNbeta-NIS To Treat Patients With Relapsed/Refractory Multiple Myleoma, Acute Myeloid Leukemia, Or T-cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS]) in treating patients with multiple myeloma, acute myeloid leukemia, or T-cell lymphoma that has come back or does not respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells.
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Efficacy And Safety Of COVID-19 Vaccine In Cancer Patients
Jacksonville, FL
We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.
Aims, purpose, or objectives:
- To determine the antibody response to COVID-19 vaccine after vaccination.
- To assess the adverse events of COVID-19 vaccines in cancer patients.
- To determine the incidence and severity of COVID-19 infection after the vaccination.
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Venetoclax In Combination With ASTX727 For The Treatment Of Chronic Myelomonocytic Leukemia And Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to test whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts.
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A Study Of Glofitamab And Lenalidomide In People With Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma
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A Study To Evaluate Individualized Prehabilitation For People Undergoing Neo-Adjuvant Radiotherapy And Lower Limb Soft-Tissue Sarcoma Surgery
Scottsdale/Phoenix, AZ
The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.
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Ibrutinib And Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, And Rituximab In Treating Patients With Untreated Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, interfere with the ability of cancer ...
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A Study Of A New Way To Treat Children And Young Adults With A Brain Tumor Called NGGCT
Rochester, MN
The purpose of this study is to monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with Induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. Also, to improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123.
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Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells.
PURPOSE: ...
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Metastatic Tumor Research And Outcomes Network
Rochester, MN
The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
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Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is determine objective response rate (ORR) by RECIST 1.1 by blinded independent central review (BICR) of envafolimab (cohort A), and of envafolimab combined with ipilimumab at 1 mg/kg (cohort B), in separate cohorts of patients with locally advanced, unresectable or metastatic UPS/MFS that has progressed following one or two lines of chemotherapy, without a formal statistical comparison between the two cohorts.
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PEA For The Relief Of Chemotherapy-Induced Peripheral Neuropathy
Eau Claire, WI; Rochester, MN
The purpose of this study the efectiveness of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN). Also, to assess the safety of PEA at the two study doses, and to evaluate changes in patient-reported symptoms and quality of life from baseline to the end of 8 weeks.
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A Study To Determine The Outcomes Of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy
Rochester, MN
AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS). Risk stratification will be determined by traditional prognosticators (tumor genetics, extent of extramedullary involvement, early response to therapy as determined by flow cytometry) combined with the new DNA-based MRD detection technology of high throughput sequencing (HTS) of the immunoglobulin heavy chain (IgH).
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Epcoritamab Compared To Observation For Treating B-cell Lymphoma Patients Not In Complete Remission After CD19-directed CAR-T Therapy
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy.
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Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine As First-Line Treatment For Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), Or Low-Blast Acute Myelogenous Leukemia (AML)
Jacksonville, FL
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves overall response rate (ORR) by Cycle 6 and whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine.
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A Study to Evaluate Early Detection of SARS-CoV-2/COVID-19 in High Risk Radiation Oncology Patients
Rochester, MN
The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients who ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.
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A Study of LY2784544 for Patients with Myeloproliferative Disorders
Scottsdale/Phoenix, AZ
The purpose of this study is to find out the safe dose range of the study drug in patients who have myeloproliferative disorders.
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A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization
Jacksonville, FL
The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.
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A Study Of APG-2575 Alone Or In Combination With Other Therapeutic Agents To Treat Relapsed And/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
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SPORT-DMG
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the clinical outcomes of hypofractionation with planned courses of re-irradiation for patients with diffuse midline gliomas of the pons.
Subjects will be screened by neurosurgery, radiation oncology, or pediatric oncology at outpatient clinic or by the multidisciplinary pediatric central nervous system tumor conference. Interested qualified patients and their families will be consented and offered participation in this study
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Reduced Craniospinal Radiation Therapy And Chemotherapy In Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma
Rochester, MN
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as ...
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Study Using Chromogranin A As Surveillance Biomarker In Patients With CARcinoids
Rochester, MN
The purpose of this study is to monitor and validate the performance and stability of the BRAHMS Chromogranin A (CgA) II KRYPTOR Assay in patients with Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).
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informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Jacksonville, FL
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported Health related Quality of Life (HRQoL).
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A Study Of ABBV-383 With Relapsed Refractory Waldenström Macroglobulinemia
Rochester, MN
The purpose of this study is to determine the safety, maximum tolerated dose (MTD) and RP2D of ABBV-383 monotherapy for patients with RRWM and to determine VGPR or deeper response as the best response achieved with ABBV 383 within 12 cycles of initiation of therapy for patients with RRWM.
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A Study To Compare Three Chemotherapy Regimens For The Treatment Of Patients With Newly- Diagnosed Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib, and to determine how well they work in treating patients with newly-diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the ...
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A Study To Evaluate The Effect Of Ripretinib On The Pharmacokinetics Of A CYP2C8 Probe Substrate In Patients With Advanced GIST
Jacksonville, FL
The purpose of this study is to evaluate the effect of Ripretinib on the pharmacokinetics of a CYP2C8 Substrate.
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Apixaban In Preventing Secondary Cancer Related Blood Clots In Cancer Patients Who Have Completed Anticoagulation Therapy
Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; Rochester, MN
This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related blood clots in cancer patients who have completed anticoagulation therapy. Apixaban may stop the clotting of blood by blocking some of the enzymes needed for blood clotting.
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A Study Of THE-630 In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Jacksonville, FL
The purpose of this study is to assess the safety, effectiveness, and pharmacokinetics of THE-630 in participants with advanced gastrointestinal stromal tumors (GIST).
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A Study Comparing Ibrutinib And Obinutuzumab With Or Without Venetoclax In Treating Patients With Chronic Lymphocytic Leukemia
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this trial is to evaluate how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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Duvelisib And Nivolumab For The Treatment Of Stage IIB-IVB Mycosis Fungoides And Sezary Syndrome
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in ...
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OPX Saliva Biomarker Study
Rochester, MN
- Salivary tumor DNA (stDNA) and the HPV self-test for oncogenic HPV (self-test) will be detectable in patients with human papillomavirus associated oropharyngeal squamous cell carcinoma (HPV(+)OPSCC) and not in HPV(-)OPSCC, oral cavity cancer or normal controls.
- There will be a difference in the microbiome, virome, and metabolomics in normal control patients compared to patients with oropharyngeal cancer or oral cavity cancer.
- There will be a difference in patient reported risk factors between patients with malignancy and normal controls.
- There will be dynamic changes in the microbiome and metabolomics which correspond with patient reported outcomes in patients with oropharyngeal cancer or ...
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Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about diagnosing cancer and determine a patient's eligibility for a treatment clinical trial. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is collecting tissue samples from patients with leukemia or other blood disorders who are planning to enroll in an ECOG leukemia treatment clinical trial.
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Dabrafenib Combined With Trametinib After Radiation Therapy In Treating Patients With Newly-Diagnosed High-Grade Glioma
Rochester, MN
The purpose of this study is to estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls.
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Cholecalciferol In Improving Survival In Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency
Scottsdale/Phoenix, AZ; Rochester, MN
This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.
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Assessing Glutamine Metabolism In MGUS And Myeloma
Rochester, MN
The utilization of glutamine by the bone marrow plasma cells in MGUS and MM will be compared between each other after infusion of 13-carbon labelled glutamine.
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Pituitary tumor registry
Rochester, MN
The purpose of this data registry involves the collection of standard of care clinical treatment regimens, diagnostic information and surgical outcomes which may include human specimens and associated genomewide expression data.
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A Study of Magnetic Resonance Elastography for Measuring Cancerous Tumor Response Following Treatment with Chemotherapy
Rochester, MN
The purpose of this study is to use magnetic resonance elastography to determine if the mechanical properties of either Hodgkin's or non-Hodgkin's lymphoma tumors change in response to the administration of chemotherapy agents (in which the agent is known to produce a positive treatment response) and that this change is detected by MRE within 24 hours following therapy.
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ONC201 In H3 K27M-mutant Diffuse Glioma Following Radiotherapy (The ACTION Study)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness of ONC201 administered following radiotherapy in participants with H3 K27M-mutant diffuse glioma.
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A Study To Evaluate LOXO-305 Vs. Approved BTK Inhibitor Approved Drugs To Treat Patients With Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
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A Study To Evaluate The Feasibility Of Memantine In Reducing Cognitive Impairment In Pediatric Patients After Radiation Therapy For Central Nervous System Tumors
Rochester, MN
The purpose of this study is to evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and continued one month after radiation therapy (RT), and to evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.
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A Study To Evaluate Lymphoma Epidemiology
Albert Lea, MN; Scottsdale/Phoenix, AZ; Austin, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to build a large and diverse observational cohort to support broad and cutting-edge research focused on non-Hodgkin lymphoma (NHL) prognosis and survivorship.
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Inotuzumab Ozogamicin And Post-Induction Chemotherapy In Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, And B-LLy
Rochester, MN
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, ...
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A Registry of Biospecimens at Mayo Clinic to Support Translational Research into the Biology, Etiology and Prognosis of Neuroendocrine Tumors
Jacksonville, FL
The purpose of this registry at Mayo Clinic Jacksonville, is to keep a database and biospecimens of all patients treated surgically and non-surgically for a gastro-enteropancreatic mass or a suspected metastatic lesion from a gastro-entero-pancreatic primary. This registry will keep demographic, clinical and pathologic data on each patient as well as follow-up information on outcome endpoints such as death and recurrence of disease, blood cell samples, and tissue samples from surgically removed tumors.
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Coronary CTA for Radiation Therapy Planning in Lymphoma Patients
Rochester, MN
Our purpose for this study is to help design a therapy plan that can decrease extra radiation exposure to your heart during radiotherapy. The therapy plan will use images obtained using a dual-source CT scanner
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Pembrolizumab Alone Or With Idelalisib Or Ibrutinib In Treating Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Other Low-Grade B-Cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas that have returned after a period of improvement or have not responded to treatment. Monoclonal antibodies can block cancer growth in different ways. Pembrolizumab may block cancer growth by blocking a cell that protects the cancer from the immune system and allowing the immune system to attack the cancer. Idelalisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab alone ...
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Study Of Tirabrutinib (ONO-4059) In Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purose of this study is to evaluate the effiectiveness, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory Primary Central Nervous System Lymphoma PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolimide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B). Mayo Clinic is only participatin gin Part B, and only in the MTR regimen.
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Topical Cannabidiol (CBD) For The Treatment Of Chemotherapy-induced Peripheral Neuropathy
Albert Lea, MN; Mankato, MN; Rochester, MN
The primary purpose of this study is to evaluate whether topical CBD improves chemotherapy-induced peripheral neuropathy (CIPN), compared to placebo, and to evaluate side effects from topical CBD cream use, compared to placebo.
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Phase 3 Study Of DCC-2618 Vs Placebo In Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
Jacksonville, FL; Rochester, MN
This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo
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A Study To Evaluate CB-839 With Radiation Therapy And Temozolomide In Treating Participants With IDH-Mutated Diffuse Astrocytoma Or Anaplastic Astrocytoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with ...
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Trial Using Keytruda As Initial Therapy In The Treatment Of Advanced Mycosis Fungoides
Jacksonville, FL
The purpose of this trial is to evaluate the antitumor activity of Pembrolizumab in patients with advanced mycosis fungoides (MF) as initial systemic therapy.
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A Study Of Ripretinib Vs Sunitinib In Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the objective response rate (ORR) by IRR of ripretinib vs sunitinib using modified Response Evaluation Criteria in Solid Tumors v1.1 – GIST-specific (mRECIST). Also, to compare the overall survival (OS) of ripretinib vs sunitinib.
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Expanded Access To Bezuclastinib To Be Coadministered With Sunitinib For Patients With Gastrointestinal Stromal Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
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A Study Of CG-806 In Patients With Relapsed Or Refractory CLL/SLL Or Non-Hodgkin's Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability and effectiveness of CG-806 for the treatment of patients with the condition of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.
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A Study to Assess Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer
Rochester, MN
The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. Note: The standard drug used for the ...
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FT819 In Subjects With B-cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, and clinical activity of FT819 in r/r B-cell malignancies, including the effect of a step-fractionated dosing schedule on mitigating safety risks and improving tolerability.
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Study To Assess The Effectiveness And Safety Of Ublituximab + TGR-1202 With Or Without Bendamustine And TGR-1202 Alone To Treat Patients With Previously Treated Non-Hodgkins Lymphoma
Jacksonville, FL
The purpose of this study is to evaluate the efficacy and safety of TGR-1202 both alone and in combination with ublituximab in the treatment of previously treated Diffuse Large B‐Cell Lymphoma patients.
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A Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy after Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
Rochester, MN
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is ...
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A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.
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STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG)
Rochester, MN
The purpose of this study is to verify the gene array data by examining the protein expression in brain tissue of diffuse intrinsic pontine glioma (DIPG) patients compared to normal healthy subjects using western blot.
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Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well combination chemotherapy and pralatrexate works in treating patients with non-Hodgkin lymphoma (NHL). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
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A Study To Evaluate VSV-hIFNbeta-NIS To Treat Patients With Relapsed/Refractory Multiple Myleoma, Acute Myeloid Leukemia, Or T-cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS]) in treating patients with multiple myeloma, acute myeloid leukemia, or T-cell lymphoma that has come back or does not respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells.
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Efficacy And Safety Of COVID-19 Vaccine In Cancer Patients
Jacksonville, FL
We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.
Aims, purpose, or objectives:
- To determine the antibody response to COVID-19 vaccine after vaccination.
- To assess the adverse events of COVID-19 vaccines in cancer patients.
- To determine the incidence and severity of COVID-19 infection after the vaccination.
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Venetoclax In Combination With ASTX727 For The Treatment Of Chronic Myelomonocytic Leukemia And Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to test whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts.
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A Study Of A New Way To Treat Children And Young Adults With A Brain Tumor Called NGGCT
Rochester, MN
The purpose of this study is to monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with Induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. Also, to improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123.
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A Study Of Glofitamab And Lenalidomide In People With Mantle Cell Lymphoma
Rochester, MN
The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma
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A Study To Evaluate Individualized Prehabilitation For People Undergoing Neo-Adjuvant Radiotherapy And Lower Limb Soft-Tissue Sarcoma Surgery
Scottsdale/Phoenix, AZ
The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.
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Ibrutinib And Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, And Rituximab In Treating Patients With Untreated Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, interfere with the ability of cancer ...
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Factors Contributing to Delay in Diagnosis of Bone/Soft Tissue Sarcoma
Rochester, MN
Information regarding the delay in diagnosis as well as the causes of the delay are lacking in the U.S. Specifically, we aim to identify patient factors and provider factors that contribute to delayed diagnosis of sarcoma.
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Global Cardio Oncology Registry
Rochester, MN
The purpose of this study is to provide a large database and platform for prospective sub-studies and eventually develop additional collaborations with a platform for clinical studies and trials following the initial pilot phase.
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A Study Investigating The Safety, Tolerability, Pharmacokinetics, And Effectiveness Of Mosunetuzumab (BTCT4465A) In Combination With CHOP Or CHP-Polatuzumab Vedotin In Participants With B-Cell Non-Hodgkin Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety, pharmacokinetics, and preliminary effectiveness of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
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A Study of the Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study will utilize Rasch analysis to study the construct validity and reliability of five shoulder-related patient-reported outcome measures in patients reporting shoulder impairment following surgery for head and neck cancer.
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Patient Adherence and Symptoms During Post-operative Fluid Restriction Protocol After Transsphenoidal Surgery
Jacksonville, FL
The objectives of this study are to survey patients during the post-operative period regarding their experience with fluid restriction including adherence and discomfort, and to document rates of hyponatremia and readmissions in post-operative patients.
Advances in endonasal, endoscopic transsphenoidal surgical techniques have decreased complications and length of stay for persons undergoing resection of sellar and suprasellar masses Previous research by investigators now at Mayo (SLS, AQH) has shown that particular interventions including fluid restriction post-operatively decrease patient morbidity (e.g., from hyponatremia) and readmissions while maintaining patient safety. However, the patient perspective on the impact of fluid restriction has not ...
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Building A Healthy Body After Cancer: Challenges And Opportunities In Healthy Exercise After Treatment For Young Adult Lymphoma Survivors
Rochester, MN
Exercise can benefit young adult cancer survivors by improving cardiovascular and pulmonary function, reducing fatigue, improving quality of life, and may even increase long term survival. Our goal is to identify specific barriers to exercise faced by young adult lymphoma survivors. In addition, we will look to survivors to guide us on the particular ways in which a health care institution might support them in physical activity. Our specific aims are: evaluate young adult lymphoma survivors’ knowledge regarding benefits of exercise after cancer treatment, identify barriers to exercise experienced by young adult lymphoma survivors, and understand the types of exercise ...
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Compare The Efficacy And Safety Of Golcadomide Plus R-CHOP Vs Placebo Plus RCHOP In Participants With Previously Untreated High-risk Large B-cell Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the investigator.
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Global Trial In APG2575 For Patients With CLL/SLL
Jacksonville, FL
The purpose of this study is to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors
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PH 1 Study To Evaluate Safety And Tolerability Of XmAb14045 In Patients With CD123-expressing Hematologic Malignancies
Jacksonville, FL
Primary Objectives
1. To determine the safety and tolerability profile of weekly IV dosing of XmAb14045
2. To identify the first dose MTD/RD
3. At first dose MTD/RD, to then identify the second (and subsequent) infusion MTD/RD
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Study Of Bcl-2 Inhibitor BGB-11417 In Participants With Mature B-Cell Malignancies
Rochester, MN
The purpose of this study is to determine the safety and tolerability of and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib.
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Myeloma Referral Study (Race, Ethnicity, and Familial Etiologic Relationship, Risk Association, and Linkage Study)
Rochester, MN
The goal of the present study is to answer the question of whether there are clinically relevant subtypes of monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma (MM) that are associated with populations at high risk for developing these conditions using an online survey and submission of de-identified medical information.
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Study Of A Triple Combination Therapy, DTRM-555, In Patients With R/R CLL Or R/R Non-Hodgkin's Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the effectiveness of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin's lymphoma.
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A Study Of TAK-981 In Combination With Rituximab In Participants With Relapsed/Refractory (R/r) CD20-positive (CD20+) Non-Hodgkin Lymphoma (NHL)
Rochester, MN
The purpose of this study is to determine the safety and tolerability of TAK-981 in combination with rituximab in participants with r/r CD20+ NHL in Phase 1b, and to evaluate the effectiveness of TAK-981 in combination with rituximab in r/r CD20+ NHL in Phase 2.
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A Study Of Investigational Immunotherapy To Determine The Safety And Effectiveness Of Nivolumab And Daratumumab, With Or Without Pomalidomide And Dexamethasone, In Patients With Relapsed/Refractory Hematologic Malignancies
Rochester, MN
The purpose of this study is to determine the side effects of treatment with Nivolumab by itself or in combination in patients with relapsed/refractory hematologic malignancies.
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Phase 1/2 Dose Escalation And Efficacy Study Of Anti-CD38 Monoclonal Antibody In Patients With Selected CD38+ Hematological Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety ...
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GB5121 In Adult Subjects With Relapsed/Refractory CNS Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, is to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.
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A Study To Compare The Effectiveness And Safety Of JCAR017 To Standard Of Care In Adult Subjects With High-risk, Transplant-eligible Relapsed Or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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Axicabtagene Ciloleucel Versus Standard Of Care Therapy As First-Line Therapy In High-Risk Large B-Cell Lymphoma
Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).
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Dose-Reduced Consolidation Radiation Therapy In Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.
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A Study Of Copanlisib And Nivolumab In Treating Participants With Recurrent Or Refractory Diffuse Large B-cell Lymphoma Or Primary Mediastinal Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate how well copanlisib and nivolumab work in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back or does not responded to the treatment. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating participants with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
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Combination Therapy Of Acalabrutinib, Venetoclax And Durvalumab To Treat Richter Transformation
Rochester, MN
The purpose of this study is to determine if the drug combination of acalabrutinib, durvalumab, and venetoclax will work to treat Richter’s transformation, and what doses of these drugs are safe for people to take. We also want to learn about the side effects of this combination. All study subjects will receive acalabrutinib, durvalumab, and venetoclax. Acalabrutinib is FDA approved for treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Durvalumab is FDA approved for treatment in lung cancers including non-small cell lung cancer and small cell lung cancer. Venetoclax is FDA approved for the treatment of CLL and SLL. ...
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Study Of Iopofosine I 131 (CLR 131) In Select B-Cell Malignancies (CLOVER-1) And Pivotal Expansion In Waldenstrom Macroglobulinemia (CLOVER-WaM)
Jacksonville, FL
This study evaluates CLR 131 in patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL) who have been previously treated with standard therapy for their underlying malignancy.
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A Phase 1/2 Study Of STP938 For Adult Subjects With Relapsed/Refractory B-Cell And T-Cell Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of STP938 as a single agent in adult subjects with R/R B-cell and T-cell lymphomas.
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A Study Of The Effectiveness And Safety Of CTL019 In Adult Patients With Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy and safety of CTL019 in adult patients with relapsed or resistant diffuse large B-cell lymphoma.
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A Study To Compare ACP-196 And Obinutuzumab With Chlorambucil, Or ACP-19 Alone, With Obinutuzumab And Chlorambucil, For Patients With Previously Untreated Chronic Lymphocytic Leukemia
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness of ACP-196 combined with obinutuzumab, or ACP-196 alone compared with obinutuzumab combined with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL).
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A Study Evaluating The Safety And Effectiveness Of JCAR017 To Treat Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Or Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the effectiveness and safety of JCAR017 in adult subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the effectiveness and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of ...
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Prospective Study of Adrenal Disorders: Clinical Registry, Imaging Analysis and Biomaterial Collection
Rochester, MN
The purpose of this research is to follow people with adrenal disorders in order to make conclusions about the natural history of a particular adrenal disease as well as effect of various therapies and interventions decided on by you and your medical team. In addition, we will collect biomaterial from you at times you are being evaluated which will be used to discover novel biomarkers which can potentially improve the accuracy of current diagnostic tests and affect the management of patients with adrenal disorders. We will also include a control group (without known adrenal disease) to compare to the volunteers ...
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A Study Using Targeted Inhibitors to Treat Specific Tumor Mutations in Patients with Meningiomas
Jacksonville, FL; Rochester, MN
This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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A Study To Investigate The Safety And Tolerability Of REGN1979 In Patients With CD20+ B-Cell Malignancies
Rochester, MN
This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab Monotherapy In Participants With Select B-Cell Malignancies (MorningSun)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]).
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Study To Evaluate Safety And Tolerability Of XmAb13676 In Patients With CD20-expressing Hematologic Malignancies
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
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A Study Of Ruxolitinib For The Treatment Of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Rochester, MN
The purpose of this study is to provide ruxolitinib through an expanded access program in the United States for the treatment of graft-versus-host disease (GVHD) in patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
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A Study To Compare Tisagenlecleucel Vs. Standard Of Care In Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
Jacksonville, FL
This is a randomized, open label, multicenter phase III trial to determine the efficacy and safety of tisagenlecleucel treatment strategy in adult patients with relapsed or refractory aggressive B-cell NHL after failure of rituximab and anthracycline containing frontline immunochemotherapy.
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Developing Criteria For Treatment Of Neurofibromatosis Type 1 Associated Optic Pathway Glioma
Rochester, MN
The purpose of this research study is to understand the natural history of vision in patients with OPG and determine if there are factors (e.g. age at diagnosis, male/female, tumor location, features of the MRI exam, etc) that predict future vision loss or change in tumor size.
Another purpose of the study is to collect and store blood and tissue samples to use for future research to evaluate if there are certain variations in DNA, RNA, or proteins that predict the likelihood of an OPG to grow or cause vision loss.
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A Study To Determine The Effects Of COVID-19 In Cancer Patients
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.
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Study Of BMF-219, In Adult Patients With Acute Leukemia (AL), Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma (MM), And Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)
Jacksonville, FL
The purpose of this study is to determine the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy (Cohorts 1, 2, 3, and 4).
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A Study Of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab In Previously Untreated Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
Rochester, MN
The purpose of this study is to assess whether minimal residual disease (MRD) driven finite calabrutinib plus venetoclax (AV) treatment is non-inferior to MRD-driven finiteenetoclax plus obinutuzumab (VO) treatment with respect to progression-free survival (PFS).
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Exploring Mechanisms Of Action And Resistance Of Therapeutic Agents In Patients With B-cell Malignancies
Jacksonville, FL
This study is being performed to understand the causes of drug resistance and to improve the treatment options for patients diagnosed with B-cell cancers. We aim to identify the reasons why certain therapies work and others don’t and as result- develop new treatments for blood cancers.
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A Study to Improve the Use of Genetic Testing in Disease Prevention and Clinical Care and to Further Understand Types of Genetic Differences that May Cause Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to form processes to get findings from targeted gene sequencing that can be acted on using two common actionable genetic disorders–familial hyperlipidemia and familial colorectal cancer.
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A Study To Evaluate Acalabrutinib With Or Without Obinutuzumab To Treat Early-Stage Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
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A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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A Study Of Oral LOXO-305 In Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Or Non-Hodgkin Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate oral LOXO-305 in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) who have failed or are intolerant to standard of care.
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A Study To Evaluate Endoscopic Endonasal Skull Base Surgery And Pituitary Surgery Quality Of Life
Rochester, MN
The objectives of this study are to:
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- Measure the short and long-term overall and nasal-specific quality of life (QOL) impact of patients undergoing Endoscopic Endonasal Skull Base Surgery (EESBS) for pituitary and sellar lesions.
- Determine the relative difference in QOL impact of EESBS for patients undergoing surgery for functional and nonfunctional pituitary adenomas.
- Generate baseline data to development and validate a site-specific endoscopic-specific comprehensive QOL for EESBS.
- Particular tumors of interest include pituitary tumors, Rathke’s cleft cysts, craniopharyngiomas, clival chordomas and chondrosarcomas.
- Specific QOL aims focus on olfaction (sense of smell), gustation (sense of taste) and nasal function.
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A Study To Evaluate Brentuximab Vedotin Or Placebo In Combination With Lenalidomide And Rituximab In Subjects With Relapsed Or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Rochester, MN
The purpose of tis study is to evaluate whether adding brentuximab vedotin helps two drugs work better to treat patients with diffuse large B-cell lymphoma (DLBCL). Participants in this study will have Diffuse Large B-cell Lymphoma (DLBCL) that has come back or not gotten better with treatment. Patients will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and ...
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CD19-Directed CAR-T Cell Therapy For The Treatment Of Relapsed/Refractory B Cell Malignancies
Rochester, MN
The purpose of this study is to find out more about the side effects of the CAR-T therapy called IC19/1563 and what dose of IC19/1563 is safe for patients.
The therapy, IC19/1563, uses some of the patients own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. In this study, some of the patient's T cells will be removed from their blood. In the laboratory, we will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat the cancer. The new modified ...
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SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy In Adults With CD33 And/or FLT3 Blood Cancers Including AML/MDS
Jacksonville, FL
This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.
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Randomized Phase II/III Trial Of Adjuvant Radiation Therapy With Cisplatin, Docetaxel-Cetuximab, Or Cisplatin-Atezolizumab In Pathologic High-Risk Squamous Cell Cancer Of The Head And Neck
Rochester, MN
This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can ...
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A Study Of The Drugs Selumetinib Versus Carboplatin/Vincristine In Patients With Neurofibromatosis And Low-Grade Glioma
Rochester, MN
The pupose of this study is to evaluate whether or not selumetinib works just as well as the standard treatment with carboplatine/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by ...
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A Study Of Tyrosine Kinase Inhibitor ICP-022 In Patients With R/r B-Cell Malignancies
Scottsdale/Phoenix, AZ; Rochester, MN
The main purpose of this study is to assess the maximal dose of ICP-022 that can be safely administered.
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Targeted Therapy Directed By Genetic Testing In Treating Pediatric Patients With Relapsed Or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, Or Histiocytic Disorder
Rochester, MN
The purpose of this Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for ...
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A Study Of Vaccine Therapy In Treating Patients With Malignant Peripheral Nerve Sheath Tumors That Are Recurrent Or Cannot Be Removed By Surgery
Rochester, MN
The purpose of this study is to assess the side effects and best dose of a genetically engineered measles virus for treating patients who have a cancerous peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent).
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Dendritic Cell Therapy, Cryosurgery, And Pembrolizumab In Treating Patients With Non-Hodgkin Lymphoma
Rochester, MN
This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such as dendritic cell therapy made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and pembrolizumab may work better at treating non-Hodgkin lymphoma.
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A Study To Compare Tisagenlecleucel Vs. Standard Of Care In Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
Jacksonville, FL
This is a randomized, open label, multicenter phase III trial to determine the efficacy and safety of tisagenlecleucel treatment strategy in adult patients with relapsed or refractory aggressive B-cell NHL after failure of rituximab and anthracycline containing frontline immunochemotherapy.
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Clinical and Laboratory Review of Patients with Myeloid Disorders
Rochester, MN
The current study is a minimal risk study that involves abstraction of clinical and laboratory information from patients with myeloid disorders with the intent to accurately define the natural history of a specific disease. The information includes survival, cause of death, disease complications, treatment, and other issues.
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Cell, Serum, and Buccal Bank for Patients with Chronic Myeloid Disorders and Acute Leukemia
Rochester, MN
This study is being done to store blood, buccal (cheek) cells, genetic material including DNA (deoxyribonucleic acid) and RNA (ribonucleic acid), and bone marrow so that they can be used for laboratory studies that may contribute to finding the causes of disease and factors that may determine disease progression and treatment response.
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Household Controls For Clinical And Epidemiological Studies In Lymphoma And Chronic Lymphocytic Leukemia
Rochester, MN
The purpose of this study is to compare the gut microbiome (GMB) profile of patients with untreated non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL) and Chronic Lymphocytic Leukemia (CLL) with controls from a normal household and age-matched population.
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Long-Term Follow-Up Of Patients Who Have Participated In Children's Oncology Group Studies
Rochester, MN
This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.
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Treatment Of Metastatic Soft Tissue Sarcoma (STS) Patients (FIBROSARC USA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic or unresectable soft-tissue sarcoma patients. In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Anti-cancer activity will ...
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A Study To Evaluate Tacrolimus/Methotrexate Versus Post-Transplant Cyclophosphamide/ Tacrolimus/Mycophenolate Mofetil In Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
Jacksonville, FL; Rochester, MN
The primary purpose of this study is to compare 1 year graft-versus-host disease (GVHD)-free, graft relapse-free survival (GRFS) between the two GVHD prophylaxis regimens.
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Human Blood and Tissues Repository for Neuroscience Research
Jacksonville, FL
The purpose of this study is to collect adult human blood, cerebrospinal fluid, brain, and spine tissues/fluids at time of surgery in order to conduct future studies of the cellular mechanisms of tissue invasion utilized by brain and spine tumors of the central nervous system (CNS).
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A Dose-Escalation And Expansion Study Of BGB-16673 In Participants With B-Cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
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A Study Of R-ICE And Lenalidomide For Treating Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement and that has not responded to previous treatment. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-ICE, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...
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Study Of Rezafungin Compared To Standard Antimicrobial Regimen For Prevention Of Invasive Fungal Diseases In Adults Undergoing Allogeneic Blood And Marrow Transplantation (ReSPECT)
Rochester, MN
The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).
The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).
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Efficacy And Safety Of REC-2282 In Participants With Progressive NF2 Mutated Meningiomas (POPLAR-NF2)
Rochester, MN
The purpose of this study is to investigate the effectiveness and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or sporadic meningiomas that have NF2 mutations.
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Efficacy And Safety Of Nemtabrutinib (MK-1026) In Participants With Hematologic Malignancies (MK-1026-003)
Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).
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A Study to Test Concussion Return to Baseline after Elective Craniotomy Procedure
Jacksonville, FL
The purpose of this study is to determine return to baseline (RTB) period after an elective craniotomy procedure using the ImPACT testing assessment.
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Symptomatic Assessment in Patients with Chronic Hematologic Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to better understand the role of survey assessment in symptom evaluation of patient with chronic hematologic malignancies.
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Collection of Sarcoma Tissue Study
Scottsdale/Phoenix, AZ
The goal of this study is to create a comprehensive system of tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of sarcoma who will or have undergone a surgical procedure to remove the sarcoma. The tissue samples will be used for future research of sarcoma at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.
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Study To Evaluate The Safety And Effectiveness Of Axicabtagene Ciloleucel In Combination With Utomilumab In Adults With Relapsed/Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward from Phase 1 into Phase 2, and to evaluate the effectiveness of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma in Phase 2.
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A Study To Evaluate The Feasibility Of Intraoperative Microdialysis (Tissue Sampling) During Neurosurgery For Central Nervous System Malignancies
Rochester, MN
Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
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An Open-label Study To Assess The Anti-Tumor Activity And Safety Of REGN1979, An Anti-CD20 X Anti-CD3 Bispecific Antibody, In Patients With Relapsed Or Refractory B-cell Non-Hodgkin Lymphoma
Rochester, MN
The primary objective of this study is to assess the anti-tumor activity of single agent REGN1979 as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) non-Hodgkin lymphoma (B-NHL) subgroups.
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A Study of the Brain & Body Donation Program
Scottsdale/Phoenix, AZ
The purpose of this study is to study the structure and biochemistry of the brain and/or bodily fluid and tissue after death. Comparison of specimens from normal and diseased individuals provide essential clues that lead to a greater understanding of the diseased state which, in turn, will lead to new ideas for therapy.
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HeadStart4: Newly Diagnosed Children (<10 Y/o) With Medulloblastoma And Other CNS Embryonal Tumors
Rochester, MN
The purpose of this study is to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a ...
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Study Of Lenzilumab And Axicabtagene Ciloleucel In Subjects With Relapsed Or Refractory Large B-cell Lymphoma
Rochester, MN
The purpose of this study is to see if giving lenzilumab prior to axicabtagene ciloleucel will reduce the neurologic side effects of axicabtagene ciloleucel when used to treat lymphoma.
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A Study of Sarcoma Tissue Collection
Scottsdale/Phoenix, AZ
The purpose of this study is to create a comprehensive system of tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of sarcoma who will or have undergone a surgical procedure to remove the sarcoma.
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Innovative Trial For Understanding The Impact Of Targeted Therapies In NF2
Rochester, MN
The purpose of this study is to test multiple experimental therapies simultaneously in patients with neurofibromatosis type 2 (NF2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2 to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. - Investigational Drug Sub-study A: Brigatinib.
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Study Treating Patients With Relapsed Or Refractory Aggressive B-cell Lymphomas Using Nivolumab With Or Without Varlilumab
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back or do not respond to treatment. Monoclonal antibodies, such as varlilumab and nivolumab, may work by stimulating the immune system to attack cancer tumor cells.
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A Study To Develop A Resource (Bank) Of Biospecimens And Data Collected From Individuals With Liver Disease And Without Liver Disease
Rochester, MN
The purpose of this study is to facilitate discovery and development of novel biomarkers of risk and early detection, etiologic factors relating to liver disease, and novel targeted therapeutic and chemopreventive strategies for liver disease such as PSC, PBC, PLD, NAFLD, NASH, ASH, HCC, donors (non-diseased and diseased) for liver transplant or non-liver diseased subjects scheduled for surgery will serve as controls.
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Mayo Clinic Cancer Center Neuro-Oncology Program Registry And Biobank For The Study Of Nervous System Tumors
Rochester, MN
Biospecimen banks are a modern attempt to centralize collections of human blood and tissue samples along with health information and personal history. The Neuro-Oncology Program Registry and Biobank will be used for research purposes to increase our understanding of nervous system tumors.
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A Study To Evaluate Clinical Transplant-Related Long-term Outcomes Of Alternative Donor Allogeneic Transplantation
Rochester, MN
The primary purpose of this study is to estimate and compare overall survival between the two arms: patients who are Very Likely to find a Matched Unrelated Donor (MUD) versus those who are Very Unlikely to find a MUD.
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A Dose Finding And Safety Study Of CC-220, Alone And In Combination With An Anti-CD20 Monoclonal Antibody (MAb) In Subjects With Relapsed Or Refractory Lymphomas
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification. Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).
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Immunogenicity And Safety Of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) In Patients With Hematologic Malignancies And Associated Precursors
Rochester, MN
The primary objective of this study is to determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies.
Secondary objectives of this study are to assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies, analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination. compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA, and analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination.
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A Study to Evaluate Diagnostic Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® in Patients Scheduled for a Liver Biopsy
Rochester, MN
We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.
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A Study to Evaluate Support Services for Managing Urological Conditions
Scottsdale/Phoenix, AZ
The purpose of this study is to assess if men and women seeking care for urological diseases have interest in support services in conjunction with standard of care.
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A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting
Rochester, MN
The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.