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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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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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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 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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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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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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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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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 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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MHealth App For Caregiver Instructino For Chemotherapy-Induced Peripheral Neuropathy
Jacksonville, FL
The purpose of this study is to assess the impact of home-based utilization of the PNR program on cancer survivors with CIPN and caregivers applying the instruction, and to develop a mobile application that will deliver the instructional program.
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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 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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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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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 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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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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A Study Of Disulfiram And Chemotherapy In Pancreas Cancer Patients
Rochester, MN
This partially randomized phase I trial studies the side effects and best dose of disulfiram when given together with gemcitabine hydrochloride in treating patients with a solid tumor that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (metastatic) and to compare whether disulfiram and gemcitabine hydrochloride may reduce tumor induced muscle loss. Weight loss occurs in pancreatic cancer patients and is common in a multitude of other cancers. Patients with metastatic cancer and weight loss sometimes are not able to receive treatment due to physical weakness or debility. Disulfiram is ...
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Early Identification Of Chemotherapy Induced Cardiac Toxicity
Rochester, MN
The purpose of this study is to determine whether changes in the following parameters of cardiac function with low intensity exercise occur following (1) treatment with cancer therapeutics or (2) cardiac rehabilitation:
- 2D and 3D left ventricular (LV) longitudinal strain and strain rate.
- Right ventricular (RV) longitudinal strain and strain rate.
- LV circumferential and radial strain and strain rate.
- 2D and 3D wall motion.
- 2D and 3D volumetric LVEF.
- Mitral valve inflow velocities (E, A) and mitral annular tissue Doppler (e’, a’).
- Tricuspid tissue velocities and TAPSE.
The study will ...
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A Study To Evaluate Diarrhea In Patients With Multiple Myeloma Receiving Conditioning Chemotherapy For Autologous Stem Cell Transplantation (SCT)
Rochester, MN
The purpose of this study is to evaluate the changes in bowel movements in patients with multiple myeloma receiving conditioning cheomotherapy for autologous stem cell transplantation (SCT).
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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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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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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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A Study of Chemotherapy in Patients with Immunoglobulin Light (or Heavy) Chain Amyloidosis
Rochester, MN
The aims of this prospective observational study will be to include all patients with systemic AL amyloidosis regardless of age or disease severity, in order to convey a ‘real-world’ picture of the disease, its response to myeloma-type chemotherapy regimens, associated toxicity and outcomes in terms of amyloidotic organ function, quality of life (QoL) and survival.
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Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients with Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, AZ; Rochester, MN
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer cells 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 cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Giving everolimus together with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ...
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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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Chemotherapy Toxicity On Quality of Life in Older Patients with Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.
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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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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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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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Stress Echo 2030
Rochester, MN
This study (SE2030) will establish a platform of data to build the perfect stress echo test, suitable for all patients, anywhere, anytime, also quantitative and operator independent.
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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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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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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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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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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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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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Single Arm Pilot Trial Of Adaptive Therapy (AT) With Capecitabine For The Treatment Of Breast Cancer
Scottsdale/Phoenix, AZ
In this study, we propose a new way of giving chemotherapy, called Adaptive Therapy (AT) using capecitabine. The goal is to prove feasibility as well as safety of this approach. We will test adaptive therapy in 35 metastatic breast cancer patients diagnosed with ER+ disease but for whom endocrine therapies have failed and use of chemotherapy is appropriate. We will recruit participants at Mayo Clinic Arizona. Chemotherapy will be given orally in an adaptive fashion, which means we will adjust the dose of the chemotherapy according to the response of the tumor. Response is measured by imaging done ...
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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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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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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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A Study Of Pertuzumab In Addition To Chemotherapy And Herceptin (Trastuzumab) As Adjuvant Therapy In Patients With HER2-Positive Primary Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (t rastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously (iv) every 3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin (trastuzumab) iv every 3 wee ks. Anticipated time on study treatment is 52 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).
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A Study To Evaluate TVB-2640 And Trastuzumab Plus Paclitaxel Or Endocrine Therapy For Treating Patients With HER2 Positive Advanced Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II trial studies how well FASN inhibitor TVB-2640 and trastuzumab plus either paclitaxel or endocrine therapy with an aromatase inhibitor work in treating patients with HER2 positive breast cancer that has spread to other places in the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and trastuzumab, 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. Endcocrine therapy helps reduce ...
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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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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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Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Rochester, MN
RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone.
PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.
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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
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
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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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 To Evaluate Chemotherapy-Induced Nausea In Breast Cancer Patients
Albert Lea, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL; Mankato, MN; Rochester, MN
The long-term goal of this study is to alleviate the occurrence of CIN and fatigue and to improve chemotherapy treatment outcomes. The identification of associations between fatigue, CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie patient symptom experience. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate fatigue and CIN.
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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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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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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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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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A Study Of Chemotherapy Selection For PM For Colorectal And Appendiceal Cancers
Rochester, MN
The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.
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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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Doxorubicin Hydrochloride, Cyclophosphamide, And Paclitaxel With Or Without Bevacizumab In Treating Patients With Lymph Node-Positive Or High-Risk, Lymph Node-Negative Breast Cancer
Mankato, 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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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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An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to offer pre-approval drug access of iniparib combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.
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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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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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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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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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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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PF-07284892 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.
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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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Testing The Addition Of Ixazomib To Lenalidomide In Patients With Evidence Of Residual Multiple Myeloma, OPTIMUM Trial
La Crosse, WI; Rochester, MN
This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.
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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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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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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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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 Elotuzumab, Daratumumab, Iberdomide, And Dexamethasone For Relapsed Multiple Myeloma
Rochester, MN
The purpose of this study is to assess the maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) in patients with relapsed MM. To determine the overall response rate with iberdomide, daratumumab, elotuzumab and dexamethasone (IberDEd) when used as therapy in patients with relapsed multiple myeloma.
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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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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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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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Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy In Previously Treated Advanced Or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations Or Other Genomic Alterations (MK-2870-004)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare MK-2870 to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations.
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A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, And Elotuzumab, Pomalidomide, And Dexamethasone Or Pomalidomide, Bortezomib, And Dexamethasone In Participants With Relapsed Or Refractory Myeloma Who Have Received An Anti-CD38 Antibody And Lenalidomide
Rochester, MN
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
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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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The Role Of Cytomegalovirus And Inflammation On Patient Symptoms And Outcomes In Ovarian Cancer
Albert Lea, MN; Mankato, MN
The purpose of this study is to determine whether a common virus, cytomegalovirus (CMV), may increase fatigue and other symptoms following treatment for ovarian cancer.
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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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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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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 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 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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A Study To Evaluate Nasal Vestibulitis Symptoms In Patients Undergoing Systemic Antineoplastic Therapy
Albert Lea, MN; Austin, MN; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate treatment-emergent nasal vestibulitis symptoms in patients undergoing systemic antineoplastic therapy.
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A Study To Assess The Effectiveness Of Osimertinib Plus Savolitinib In Patients With Locally Advanced Or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Osimertinib Treatment (SAVANNAH Study) Following Prior Osimertinib
Rochester, MN
The purpose of this study (the SAVANNAH study) is tol investigate the effectiveness of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have progressed following treatment with osimertinib.
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Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Rochester, MN
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. 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. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
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A Study To Evaluate AuTophagy Activation For Cardiomyopathy Due To Anthracycline TReatment
Rochester, MN
The purpose of this study is to evaluate the additional benefit of pravastatin and spironolactone when given in combination with carvedilol and lisinopril versus carvedilol and lisinopril alone.
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A Study Of Catequentinib, Anlotinib In Metastatic Or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma And Synovial Sarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of AL3818 (catequentibub, anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
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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 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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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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S1406 A Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Rochester, MN
This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without ...
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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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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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Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer
Jacksonville, FL
This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, 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. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.
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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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Radiation Therapy in Treating Patients with Extensive Stage Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.
PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.
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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 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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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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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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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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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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A Study Of Elotuzumab, Daratumumab, Iberdomide, And Dexamethasone For Relapsed Multiple Myeloma
Rochester, MN
The purpose of this study is to assess the maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) in patients with relapsed MM. To determine the overall response rate with iberdomide, daratumumab, elotuzumab and dexamethasone (IberDEd) when used as therapy in patients with relapsed multiple myeloma.
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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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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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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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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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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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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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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 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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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 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 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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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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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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Gemcitabine And Cisplatin As Neoadjuvant Chemotherapy In Patients With High-Grade Upper Tract Urothelial Carcinoma
Scottsdale/Phoenix, AZ
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
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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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Lenalidomide Or Observation In Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
Rochester, MN
This phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk smoldering multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient.
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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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Brightline-1: A Study To Compare Bi 907828 With Doxorubicin In People With A Type Of Cancer Called Dedifferentiated Liposarcoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer.
Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and ...
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A Study To Evaluate 9-ING-41 As A Single Agent Or In Combination With Ruxolitinib In Myelofibrosis Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness of 9-ING-41, either by itself or in combination with Ruxolitinib, in patients with advanced myelofibrosis. 9-ING-41 has anti-cancer clinical activity while not causing myelosuppression, and has both pre-clinical anti-fibrotic activity and activity against myelofibrosis. 9-ING-41 may reduce the dose of Ruxolitinib needed for optimal therapeutic response and/or reverse myelosuppression so than an adequate dose of Ruxolitinib can be tolerated for an adequate duration to confer an optimal therapeutic outcome.
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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 Of I-DXd In Combination With Atezolizumab With Or Without Carboplatin As First-Line Induction Or Maintenance In Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of I-DXd in combination with immune checkpoint inhibitor atezolizumab with or without carboplatin in subjects with ES-SCLC in the first-line (1L) setting.
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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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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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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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A Study of the Safety and Effectiveness of INC280 Alone and in Combination with Erlotinib, When Compared to Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutation and Amplified cMET
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose, the next recommended study dose, and the anti-tumor activity and safety of INC280 alone and in combination with erlotinib, when compared to standard platinum with pemetrexed chemotheapy in adult patients who have EGFR mutated and cMET amplified advanced/metastatic non-small cell lung cancer,and have acquired resistance to prior EGFR tyrosine kinase inhibitors.
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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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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 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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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 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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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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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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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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Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant To Dara-VCD Chemotherapy Alone For People Who Have Newly Diagnosed AL Amyloidosis
Rochester, MN
The purpose of this study compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain amyloidosis.
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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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Ventricular Remodeling and Myocardial Deformation in Patients Undergoing Chemotherapy for Sarcomas
Rochester, MN
The aim of this study is to determine if there is subclinical systolic or diastolic myocardial mechanical dysfunction by 2D and 3D speckle tracking echocardiography derived strain and strain rate in this patient population at baseline, during and after chemotherapy. This could be an early marker of myocardial dysfunction in patients treated for sarcoma.
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CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin
Jacksonville, FL
This study evaluates the combination of CBT-1® and doxorubicin for the treatment of metastatic, unresectable sarcoma in patients who have progressed after treatment with 150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day cycle, as well as doxorubicin on days 5 and 6.
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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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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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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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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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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 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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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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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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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 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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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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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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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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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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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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Treatment of IgG4-Related Disease With Revlimid and Rituximab
Rochester, MN
Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who have persistent or recurrent disease despite standard therapies, does combination therapy with rituximab and revlimid cause a sustained disease remission?
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Incidence of Chemotherapy and Targeted Therapy-Related Nasal Vestibulitis
Rochester, MN
The purpose of this study is to determine the percentage of patients receiving cancer-directed therapy at the Gonda 10 chemotherapy unit who have had or are currently experiencing symptoms of nasal vestibulitis.
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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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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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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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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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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 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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A Study To Evaluate IMGN632 With Venetoclax And/or Azacitidine To Treat Patients With CD123-Positive Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is is to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in patients with relapsed and frontline CD123-positive AML, and antileukemia activity of IMGN632 when administered as monotherapy in patients with MRD+ AML after frontline treatment.
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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 To Evaluate Duloxetine To Prevent Oxaliplatin-Induced Peripheral Neuropathy In Patients With Stage II-III Colorectal Cancer
Eau Claire, WI; Mankato, MN; Rochester, MN
The purpose of this study is to determine the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
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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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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 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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Fucoidan For Patients With Chemotherapy-Related Fatigue
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of fucoidan vs. placebo in preventing fatigue as assessed by a single-item measure of fatigue (Appendix 1, Linear Analog Scale of Fatigue) at 8 weeks following the initiation of platinum-based doublet/triplet.
The Fucoidan dose of 400 mg formulation is specifically being made for this trial.
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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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Olaparib In Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well olaparib works in treating patients with biliary tract cancer that has spread to other places in the body (metastatic) and with aberrant DNA repair gene mutations. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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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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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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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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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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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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A Study To Test The Addition Of The Drug Cabozantinib To Chemotherapy In Patients With Newly Diagnosed Osteosarcoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill ...
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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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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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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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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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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 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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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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Veliparib With Carboplatin And Paclitaxel And As Continuation Maintenance Therapy In Subjects With Newly Diagnosed Stage III Or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
Rochester, MN
The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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A Phase 2 Study Of CPI-0610 With And Without Ruxolitinib In Patients With Myelofibrosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of trhis study is to evaluate CPI-0610 in patients who have both received JAK inhibitors, such as ruxolitinib (Arms 1 and 2), and in patients who have never been treated with a JAK inhibitor (Arm 3). Patients who participate in Arm 1 will be treated with CPI-0610 alone (monotherapy arm), patients who participate in Arm 2 will be treated with CPI-0610 in combination with ruxolitinib (combination arm), and patients who have never been treated with a JAK inhibitor who participate in Arm 3, will also be treated with CPI-0610 and ruxolitinib, a JAK inhibitor (JAKi naïve arm).
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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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A Study To Evaluate Gemcitabine In Patients Undergoing Radical Nephroureterectomy For Upper Tract Urothelial Carcinoma
Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the effectiveness of a single intraoperative intravesical instillation of gemcitabine at time of radical nephroureterectomy (RNU) to prevent intravesical recurrence of urothelial carcinoma (UC) at 1 year in patients with clinically localized upper tract urothelial carcinoma (UTUC).
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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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A Study To Compare Treatment With The Drug Selumetinib Alone Versus Selumetinib And Vinblastine In Patients With Recurrent Or Progressive Low-Grade Glioma
Rochester, MN
The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.
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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 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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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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(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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Vinorelbine Tartrate and Cyclophosphamide in Combination with Bevacizumab or Temsirolimus in Treating Patients with Recurrent or Refractory Rhabdomyosarcoma
No Locations
This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide work in combination with bevacizumab or temsirolimus in treating patients with recurrent or refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and cyclophosphamide, 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 find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop ...
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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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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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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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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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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 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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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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Veliparib With Carboplatin And Paclitaxel And As Continuation Maintenance Therapy In Subjects With Newly Diagnosed Stage III Or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
Rochester, MN
The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal 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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A Phase 2 Study Of CPI-0610 With And Without Ruxolitinib In Patients With Myelofibrosis
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of trhis study is to evaluate CPI-0610 in patients who have both received JAK inhibitors, such as ruxolitinib (Arms 1 and 2), and in patients who have never been treated with a JAK inhibitor (Arm 3). Patients who participate in Arm 1 will be treated with CPI-0610 alone (monotherapy arm), patients who participate in Arm 2 will be treated with CPI-0610 in combination with ruxolitinib (combination arm), and patients who have never been treated with a JAK inhibitor who participate in Arm 3, will also be treated with CPI-0610 and ruxolitinib, a JAK inhibitor (JAKi naïve arm).
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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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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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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 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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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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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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A Study to Assess AC220 Given in Combination with Induction and Consolidation Therapy for Newly Diagnosed Acute Myeloid Leukemia (AML)
Jacksonville, FL
The purpose of this study is to define the maximum tolerated dose of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
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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 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 Comparing Temozolomide and Selumetinib for Treating Patients with Metastatic Melanoma of the Eye
Rochester, MN
The purpose of this study is to compare the effectiveness of temozolomide to selumetinib for the treatment of patients who have melanoma of the eye that has spread to other places in the body. 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 by stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.
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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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A Trial To Find And Investigate A Safe Dose Of BI 836858 In Combination With Decitabine For Patients With Acute Myeloid Leukemia (AML)
Jacksonville, FL
Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
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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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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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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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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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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 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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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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Testing The Use Of Chemotherapy After Surgery For High-Risk Pancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine 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. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
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A Study to Evaluate Immune Response Changes to Ovarian Cancer During Chemotherapy
Rochester, MN
The study will determine whether the type and number of immune cells (white blood cells) in ovarian cancer tumors after initial chemotherapy impacts ovarian cancer patient outcomes.
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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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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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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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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 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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Venetoclax, Ixazomib Citrate, And Dexamethasone In Treating Patients With Relapsed Multiple Myeloma
Rochester, MN
This phase I/II trial studies the side effects and best dose of venetoclax when given together with ixazomib citrate and dexamethasone and to see how well they work in treating patients with multiple myeloma that has come back. Venetoclax and 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 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. Giving venetoclax together with ixazomib citrate and ...
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A Study To Evaluate Pembrolizumab With Standard Therapy To Treat Newly-diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. Drugs used in the chemotherapy, such as pembrolizumab 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. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.
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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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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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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 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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A Study To Analyze NMS-03305293 And Temozolomide In Adult Patients With Recurrent Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I), and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).
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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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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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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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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 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 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 Safety To Evaluate The Safety And Effectiveness Of Pressurized Intraperitoneal Aerosolized Chemotherapy In Ovarian, Uterine, Colorectal, And Gastric Cancer Patients
Jacksonville, FL
The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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A Safety To Evaluate The Safety And Effectiveness Of Pressurized Intraperitoneal Aerosolized Chemotherapy In Ovarian, Uterine, Colorectal, And Gastric Cancer Patients
Jacksonville, FL
The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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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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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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High-Dose Radiation Therapy Versus Standard Care in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery
Rochester, MN; La Crosse, WI
This randomized phase II trial studies how well standard systemic chemotherapy followed by intensified radiochemotherapy or standard radiochemotherapy preceded by intensified systemic chemotherapy works compared to standard systemic chemotherapy followed by standard radiochemotherapy in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride or FOLFIRINOX, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving ...
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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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Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
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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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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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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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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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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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Pertuzumab And Trastuzumab As Neoadjuvant Treatment In Patients With HER2-Positive Breast Cancer
Rochester, MN
This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.
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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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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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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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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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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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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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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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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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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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Cyclophosphamide and Vaccine Therapy in Treating Patients with Stage II-III Breast, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Rochester, MN
This study is being done to gather information. The study will provide important information related to the safety and the effect of the vaccine on a patient's immune system. What researchers learn from this study could possibly be used in the future to prevent or delay recurrence of breast or ovarian cancers.
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Study Of Gastric Cancer And Limited Peritoneal Metastasis Using Robotic Cytoreduction And Hyperthermic Intraperitoneal Chemotherapy
Rochester, MN
The purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy.
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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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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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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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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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Specialty Compared To Oncology Delivered Palliative Care For Treating Acute Myeloid Leukemia
Rochester, MN
The purpose of this study is to evaluate whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).
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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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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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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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A Study To Determine The Best Individualized Cancer Therapy Using Circulating Tumor DNA (CtDNA) In Patients With GI, CNS, And Thoracic Cancers.
Jacksonville, FL
This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.
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Focused Radiation Versus Systemic Therapy For Kidney Cancer Patients With Limited Metastasis, SOAR Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to compare the effect of stero-ablative radiotherapy (SAbR) followed by standard of care systemic therapy, to standard of care systemic therapy alone, in patients with kidney cancer that has spread from where it first started (primary site) to a limited (2-5) number of places in the body (metastatic).
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Improving Adolescent And Young Adult Self-Reported Data In ECOG-ACRIN Trials
Rochester, MN
The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
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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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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 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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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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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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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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Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
No Locations
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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: ...
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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 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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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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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 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 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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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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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 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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A Study To Evaluate Pembrolizumab Combined With Intensive Chemotherapy To Treat Patients With Acute Myeloid Leukemia
Jacksonville, FL
The purpose of this study is to determine how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, idarubicin, and daunorubicin, 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. 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. Giving induction chemotherapy with pembrolizumab may work ...
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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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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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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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A Phase II, Multicenter Study Of The EZH2 Inhibitor Tazemetostat In Adult Subjects With INI1-Negative Tumors Or Relapsed/Refractory Synovial Sarcoma
Jacksonville, FL
This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID administered orally in continuous 28 day cycles. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. Eligible subjects will be enrolled into one of fivecohorts based on tumor type: - Cohort 1: MRT, RTK, ATRT, or selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid tumor of the ovary [MRTO] - Cohort 2: Relapsed or refractory synovial sarcoma with SS18-SSX ...
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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 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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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 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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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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Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
No Locations
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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: ...
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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 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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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 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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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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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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Study Of Pembrolizumab (MK-3475) Combination Therapies In Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.
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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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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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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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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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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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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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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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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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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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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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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 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 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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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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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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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 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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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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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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RegoNivo Vs Standard Of Care Chemotherapy In AGOC
Scottsdale/Phoenix, AZ
To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.
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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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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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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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Cabozantinib-S-Malate In Treating Younger Patients With Recurrent, Refractory, Or Newly Diagnosed Sarcomas, Wilms Tumor, Or Other Rare Tumors
Rochester, MN
This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.
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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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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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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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Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP In Newly Diagnosed High-intermediate And High Risk DLBCL Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL.
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A Study To Evaluate Immunotherapy For Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objectives of this study are to evaluate safety/tolerability and immunogenicity of IMU-201 as monotherapy and in combination with an immune checkpoint inhibitor (ICI) or an ICI and chemotherapy in participants with advanced NSCLC tumors that are positive for PD-L1, and to identify the Optimal Biological Dose (OBD) of IMU-201 as monotherapy and in combination with an ICI, or an ICI and chemotherapy, in participants with advanced NSCLC tumors that are positive for PD-L1.
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A Study Of Multiple Therapies In Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.
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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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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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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
Mankato, MN
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.
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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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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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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 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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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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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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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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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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Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye
Rochester, MN
This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, 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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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 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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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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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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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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Nab-Paclitaxel And Bevacizumab In Treating Patients With Unresectable Stage IV Melanoma Or Gynecological Cancers
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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 find tumor cells and help kill them or carry tumor-killing ...
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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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Study Of Oraxol And Pembrolizumab In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine dose escalation of paclitaxel administered as Oraxol in combination with Pembrolizumab, and dose expansion to assess the ORR per Response Evaluation Criteria in subjects with advanced Solid Tumors, Urothelial Carcinoma, Gastric cancer, Gastro-esophageal cancer, and Non-small cell lung cancer.
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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 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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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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Study To Assess Enzastaurin + R-CHOP In Subjects With DLBCL With The Genomic Biomarker DGM1™
Rochester, MN
The purpose of this study is to enroll approximately 235 treatment-naïve subjects with high-risk Diffuse Large B-Cell Lymphoma (DLBCL). Subjects will be randomized 1:1 to R-CHOP plus enzastaurin or R CHOP (plus placebo during induction). All subjects will receive up to 6 cycles (3 weeks per cycle) of treatment. PET/ CT will be used to assess radiographic response at the end of treatment. Each subject's treatment assignment will be unblinded after initial phase of treatment. Subjects randomized to the enzastaurin arm who have a response will be offered maintenance treatment of the study drug for up to 2 additional years.
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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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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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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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De-Escalated Adjuvant And Definitive Radiation Therapy Informed By DART 2.0 CtHPV-DNA
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary goal of this study is to prospectively incorporate ctHPVDNA in combination with clinical and pathologic factors to appropriately select patients for treatment intensity.
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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A Study of Pertuzumab Combined with High-Dose Trastuzumab for Patients who have Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer with Central Nervous System Progression After Radiation Therapy
Jacksonville, FL
This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.
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A Study To Evaluate Decreasing Chemotherapy For Breast Cancer Patients After Pre-surgery Chemo And Targeted Therapy
Eau Claire, WI; La Crosse, WI; Rochester, MN
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. 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. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on ...
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A Study Of Taxane, Trastuzumab, And Pertuzumab With Or Without Atezolizumab In Treating Metastatic Breast Cancer Patients
Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to evaluate how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of 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. Immunotherapy with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ...
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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 Using A New Drug, Nivolumab, In Combination With Chemotherapy Drugs To Treat A Type Of Cancer Called Nasopharyngeal Carcinoma (NPC)
Rochester, MN
This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. 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. Chemotherapy drugs, 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. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer ...
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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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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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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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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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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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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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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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Tamoxifen Citrate, Letrozole, Anastrozole, Or Exemestane With Or Without Chemotherapy In Treating Patients With Invasive RxPONDER Breast Cancer
Mankato, MN
This study is being reopened with Mayo IRB for long-term follow-up data purposes only. The initial study IRB# 12-009536 was "completed" prematurely as not all data collection activities had been completed. This study was always separately filed in Rochester and Mankato with two different PIs. Rochester is still open and Mankato was completed prematurely.
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A Study Of To Evaluate Palbociclib In Combination With Letrozole And Trastuzumab In Stage II-III ER+ HER2+ Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer in order to influence estrogen receptor (ER) signaling.
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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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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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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 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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A Study Of Pembrolizumab And Ruxolitinib Phosphate For Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab for treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating patients with stage IV triple negative breast cancer.
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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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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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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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A Study Of Alisertib In Combination With Endocrine Therapy In Patients With HR-positive, HER2-negative Recurrent Or Metastatic Breast Cancer (ALISCA-Breast1)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
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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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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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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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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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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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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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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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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 Comparing Combinations of Chemotherapy for Treating Women who have Undergone Surgery for Node-Positive Breast Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare three different combination chemotherapy regimens and evaluate how well they work in treating women who have undergone surgery for node-positive breast cancer. Drugs used in chemotherapy, such as docetaxel, doxorubicin, cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
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A Study To Evaluate Tazemetostat And Pembrolizumab To Treat Advanced Urothelial Carcinoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to conduct a safety lead-in phase that identifies the safe recommended phase II dose for combination tazemetostat and MK-3475 (pembrolizumab) in patients with advanced urothelial carcinoma.
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EF-41/KEYNOTE D58: Phase 3 Study Of Optune Concomitant With Temozolomide Plus Pembrolizumab In Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
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FT516 In Subjects With Advanced Hematologic Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate appropriate dosage of FT516 as monotherapy in acute myeloid leukemia (AML), and in combination with CD20 directed monoclonal antibodies, in B-cell lymphoma. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.
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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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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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A Study To Evaluate The Efficacy And Safety Of Daratumumab In Combination With Cyclophosphamide, Bortezomib And Dexamethasone (CyBorD) Compared To CyBorD Alone In Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
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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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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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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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Belantamab, Lenalidomide, And Daratumumab For Newly-diagnosed Multiple Myeloma
Rochester, MN
The purpose of the phase 1 portion of this research study is to find out more about the side effects of belantamab and what doses of belantamab are safe for people when combined with lenalidomide and daratumumab, and to find the right dose for the phase 2 portion of the trial.
This trial is exploring the use of a new drug called belantamab to be used in combination with daratumumab and lenalidomide and not using the same doses of dexamethasone as has been done with previous combinations. Belantamab is an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate. This ...
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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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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 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 Assess Cisplatin And Combination Chemotherapy In Treating Children And Young Adults With Hepatoblastoma Or Liver Cancer After Surgery
Rochester, MN
The purpose of this study is to determine how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, 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 combination chemotherapy after surgery may kill more tumor cells.
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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 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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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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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 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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Oligomets Pancreas SBRT
Jacksonville, FL
The primary endpoint for this study will compare PFS between SBRT + standard chemotherapy vs. standard chemotherapy alone in patients with oligometastatic pancreatic cancer. PFS is defined as the time from randomization to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria and will be documented at each enrolling site with no central review planned.
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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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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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Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients with Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
Rochester, MN
This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare ...
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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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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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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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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 Chemotherapy and Radiation Therapy With or Without Surgery to Treat Patients With Head and Neck Cancer
Rochester, MN
The purpose of this study is to determine whether intensification of radiation, relative to conventional fractionation plus cisplatin in the combined therapy setting can further improve the overall survival of patients with advanced HNSCC, to assess the actuarial local-regional control and disease-free rates of patients treated with the different regimens, to define the acute and late toxicity of each treatment regimen, to evaluate whether there are differences in patient’s QOL, perception of side effects, and performance status between treatment arms, to establish whether EGFR and COX-2 expressions are independent prognostic markers for patients receiving concurrent chemoradiation.
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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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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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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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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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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 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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Eliminating Breast Cancer Surgery In Exceptional Responders With Neoadjuvant Systemic Therapy
Rochester, MN
The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.
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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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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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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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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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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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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 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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A Study To Evaluate Niraparib And TSR-042 In Patients With Germline Or Somatic BRCA1/2 And PALB2-related Pancreatic Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that ...
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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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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 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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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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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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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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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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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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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 To Evaluate Chemoradiotherapy With Or Without Atezolizumab In Treating Patients With Localized Muscle Invasive Bladder Cancer
Scottsdale/Phoenix, AZ; Eau Claire, WI; La Crosse, WI; Rochester, MN
The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
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Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy For Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the antitumor effectiveness and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and ...
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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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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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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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Spearhead 1 Study In Subjects With Advanced Synovial Sarcoma Or Myxoid/Round Cell Liposarcoma
Jacksonville, FL
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
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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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Aggressive Smoldering Curative Approach Evaluating Novel Therapies And Transplant
Rochester, MN
This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
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A Study To Evaluate Daratumumab/rHuPh20 +/- Lenalidomide As Post-ASCT Maintenance For Multiple Myeloma With Minimal Residual Disease (MRD) To Direct Therapy Duration
Scottsdale/Phoenix, AZ; Eau Claire, WI; Rochester, MN
The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.
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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.