Soft tissue sarcoma

Displaying 74 studies

  • A Patient Access Program of Olaratumab for the Continued Treatment of Soft Tissue Sarcoma Jacksonville, FL

    The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).

  • A Phase 1B Dose-escalation Study of TRC105 in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma Jacksonville, FL; Rochester, MN

    The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose pazopanib in patients with advanced soft tissue sarcoma.

    The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft tissue sarcoma by RECIST 1.1.

  • A Phase 2 Study of Anti-PD-L1 Antibody Atezolizumab in Alveolar Soft Part Sarcoma Rochester, MN

    Background: Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS. Objective: To test good and bad effects of the drug atezolizumab. Eligibility: People at least 6 years old with ASPS that cannot be cured with surgery Design: Participants will be screened with heart and pregnancy tests. Some may ...

  • A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity Jacksonville, FL

    This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.

  • A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma Jacksonville, FL

    The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.

  • Phase 3 Study to Treat Patients with Soft Tissue Sarcomas Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.

  • Retrospective Review of Radiological Findings of Uterine Leiomyosarcoma in Comparison with Those of Atypical Leiomyoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to retrospectively review the imaging findings of the uterine leiomyosarcoma and compare with those of atypical leiomyoma.

  • Analysis of Outcomes in Sarcoma Reconstruction Using Intraoperative Fluorescence Angiography Jacksonville, FL

    The primary objective of the study is to compare outcomes of patients undergoing sarcoma reconstructive surgery using fluorescence angiography with patients undergoing sarcoma reconstructive surgery without fluorescence angiograph.

  • MDM2 Inhibitor AMG-232 and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 and radiation therapy in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving MDM2 inhibitor AMG-232 and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

  • Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery Rochester, MN

    This randomized phase II/III trial studies how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in combination with pazopanib hydrochloride or combination chemotherapy in treating patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin hydrochloride, 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. Pazopanib hydrochloride may stop the ...

  • A Study to Evaluate Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery Scottsdale/Phoenix, AZ

    The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.

  • Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk Rochester, MN

    We propose conducting a single arm, prospective study to evaluate the efficacy and safety of a preoperative hypofractionated course, 42.75 Gy in 15 fractions, for localized, extremity and superficial trunk soft tissue sarcomas. The biologic equivalent dose of this regimen is 45.20 Gy10, similar to 43.83 Gy10 associated with conventionally fractionated 50 Gy in 25 fractions, to determine acute wound complications rates, analyze local failure rate, disease-free survival, overall survival, patterns of relapse, late toxicities, quality of life/patient-reported outcomes, and cost differences. We hypothesize a 15 fraction hypofractionated radiation therapy course will be associated with equivalent short term toxicity ...

  • 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.

  • Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation Jacksonville, FL; Rochester, MN

    This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

  • A Study to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors Rochester, MN; Jacksonville, FL

    To evaluate the effectiveness of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with NY-ESO-1- and/or LAGE-1a positive solid tumors.

  • A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma Jacksonville, FL

    The purpose of this study is to test the safety and effectives of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

  • A Study of T-VEC and Radiation to Treat Localized Soft Tissue Sarcoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the side effects of talimogene laherparepvec and radiation therapy to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.

  • Blood-Based Biomarkers in Sarcoma: A ‘Multi-Omics’ Approach Rochester, MN

    The purpose of this research is to determine whether circulating tumor DNA, RNA or proteins can be detected in the blood of patients with sarcoma. We are also interested in learning if these levels change over time while receiving chemotherapy. Patients with advanced sarcoma who will receive chemotherapy will be asked to participate. Study participation involves blood-draws of approximately 4 tablespoons of blood at each of 4 separate time-points as well as access to archived tumor tissue, or fresh tumor tissue at the time of clinically indicated biopsy or surgery.  We hypothesize that circulating tumor DNA, RNA and/or proteins ...

  • Combination Chemotherapy in Treating Patients with Non-Metastatic Extracranial Ewing Sarcoma Rochester, MN

    This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, 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. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.

  • A Study of Advanced MR Imaging in Sarcoma Patients Rochester, MN

    The purpose of this study is to compare the clinical application of two emerging magnetic resonance (MR) imaging modalities which Mayo Clinic has the technical capability of using, by adding them at the same time that standard imaging is done for patients receiving treatment for Ewing Sarcoma , Rhabdomyosarcoma and soft tissue sarcoma.  

  • A Study to Evaluate Olaparib and Temozolomide in Treating Patients With Advanced, Metastatic, or Unresectable Uterine Leiomyosarcoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that has spread to other places of the body or cannot be removed by surgery. Olaparib 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, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with ...

  • Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma Jacksonville, FL; Rochester, MN

    The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.

  • A Randomized Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients with Advanced Angiosarcoma (TAPPAS) Jacksonville, FL; Rochester, MN

    This is a study of TRC105 in combination with standard dose pazopanib compared to single agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g., metastatic or bulky disease, and disease for which surgical resection would carry an unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.

  • Abemaciclib Versus Placebo in Patients With Advanced Dedifferentiated Liposarcoma Jacksonville, FL

    The purpose of this study is to evaluate abemaciclib versus placebo to treat Advanced Dedifferentiated Liposarcoma. Patients with progression of disease will cross over to open label abemaciclib.

  • 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 ...

  • 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 ...

  • Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma (MANTRA) Jacksonville, FL

    The purpose of this study is to evaluate the safety and effectiveness of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

  • Selinexor in Advanced Liposarcoma Jacksonville, FL; Rochester, MN

    This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 279 total patients will be randomized to study treatment (selinexor or placebo).

  • 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 ...

  • Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is well tolerated with minimal side effects, the investigators propose a phase II study to evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic disease who are not candidates for cytotoxic chemotherapy.

  • A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine the efficacy of pembrolizumab in patients with advanced sarcomas.

  • A Study to Evaluate Abemaciclib to Treat Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration Jacksonville, FL

    The purpose of this study is to evaluate the 12-week progression free survival (PFS) rate in treated subjects, based on historical sarcoma trial outcomes (PFS at 12 weeks ≤ 20% will be considered a negative outcome, and 12- week PFS rate of 40% or more will be considered positive).

     

     

  • Outcomes for Hand and Foot Soft Tissue Sarcomas Treated with Limb Sparing Multimodal Therapy Rochester, MN

    Goals:

    1. Report and describe patient-reported functional outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

    2. Describe radiotherapy volumes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

    3. Report local control outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

    4. Report survival outcomes for hand and foot soft tissue sarcomas treated with limb sparing surgery and radiation therapy.

  • A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma Jacksonville, FL

    The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.

  • Proton or Photon RT for Retroperitoneal Sarcomas Rochester, MN

    This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.

    Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, ...

  • 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.

     

  • A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose (MTD) of the combination of NOX66 and doxorubicin.

  • 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.

  • A Study of Catequentinib, Anlotinib in Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ

    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.

  • A Study to Evaluate ADP-A2M4 SPEAR™ T Cells in Subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma Jacksonville, FL

    The purpose of this study is to evaluate genetically-engineered ADP-A2M4 in HLA-A*02 subjects with metastatic or inoperable (advanced) Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) who have received prior chemotherapy and whose tumor expresses the MAGE-A4 tumor antigen.

  • A Two-part Phase IIb Trial of Vigil in Ewing's Sarcoma Jacksonville, FL

    The purpose of this study is to determine the overall survival of patients treated with Vigil versus gemcitabine/docetaxel.

     

  • A Study of Vaccine Therapy in Treating Patients with Malignant Peripheral Nerve Sheath Tumors that are Recurrent or Cannot Be Removed by Surgery Rochester, MN

    The purpose of this study is to assess the side effects and best dose of a genetically engineered measles virus for treating patients who have a cancerous peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent).

  • Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ

    The purpose of this study is to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until such time that ripretinib becomes commercially available or the Sponsor chooses to discontinue the program.

  • A Study to Evaluate Circulating Cell Free Tumor DNA as a Biomarker in Sarcoma Rochester, MN

    The purpose of this study is to determine the feasibility of ctDNA detection in patients with advanced translocation-associated sarcomas.

  • 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.

  • 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.

  • A Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients With Advanced GIST Jacksonville, FL

    The purpose of this study is to evaluate the effect of Ripretinib on the pharmacokinetics of a CYP2C8 Substrate.

  • 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).

  • An Early Access Program (EAP) for Avapritinib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor Rochester, MN

    The purpose of this expanded access program is to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.

  • Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies Jacksonville, FL; Rochester, MN

    This is a 2‑arm, randomized, placebo-controlled, double‑blind, international, multicenter study comparing the efficacy of DCC-2618 to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients will be randomized in a 2:1 ratio to DCC‑2618 150 mg QD or placebo

  • A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Comparison to Sunitinib in Patients with Gastrointestinal Stromal Tumour After Progression with Imatinib Jacksonville, FL; Rochester, MN

    The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day

  • Vinorelbine Tartrate and Cyclophosphamide in Combination with Bevacizumab or Temsirolimus in Treating Patients with Recurrent or Refractory Rhabdomyosarcoma Rochester, MN

    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 ...

  • A Study of DCC-2618 vs. Sunitinib in Advanced GIST Patients after Treatment with Imatinib Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare the effectiveness of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 358 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).

  • A Blanket Protocol to Study Oral Regorafenib in Patients with Selected Sarcoma Subtypes Jacksonville, FL; Rochester, MN

    Regorafenib might or might not slow down the growth of your tumor, or shrink your tumor. Regorafenib is approved in the United States to treat colon cancer and one form of sarcoma (GIST), but we do not know if regorafenib is useful to treat people with liposarcoma, osteosarcoma, and Ewing / Ewing-like sarcomas.

    One drug like regorafenib, called pazopanib, is approved to treat some sarcomas, but is not approved to treat liposarcoma, osteosarcoma.

    Since we do not know if any of these types of drugs help people with liposarcoma, osteosarcoma, or Ewing/Ewing-like sarcoma, our goal in this study ...

  • 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.

  • Biomarkers in Sarcoma Rochester, MN

    The objective of this study is to leverage novel molecular assays to identify  predictive and prognostic biomarkers for sarcoma.

  • 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 ...

  • Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy Rochester, MN

    This pilot randomized clinical trial studies the effects, good and/or bad, of taking doxepin hydrochloride compared to placebo (inactive drug) in treating esophageal pain in patients with thoracic cancer receiving radiation therapy to the thorax with or without chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently shown to be helpful for mouth pain in patients receiving radiation therapy. Part of doxepin hydrochloride's drug action takes place at the surface of the esophagus, which may be helpful in reducing the pain caused by radiation therapy.

  • Master Protocol to Assess the Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors Jacksonville, FL

    The purpose of this trial is to evaluate the safety and effectiveness of first time in human engineered T-cell therapies, in participants with advanced tumors.

  • A Study to Determine the Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies No Locations

    The primary purpose of this study is to assess the safety and tolerability of TAB001 in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB001, 2) evaluate antitumor activity of TAB001; 3) determine the immunogenicity of TAB001 , and 4) evaluate pharmacodynamic effects of TAB001 on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of TAB001, 2) evaluate the utility of PD-L1 & ...

  • 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.

  • (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

  • 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 ...

  • A Study of Sarcoma Tissue Collection Scottsdale/Phoenix, AZ

    The purpose of this study is to create a comprehensive system of tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of sarcoma who will or have undergone a surgical procedure to remove the sarcoma. 

     

  • Factors Contributing to Delay in Diagnosis of Bone/Soft Tissue Sarcoma Rochester, MN

    Information regarding the delay in diagnosis as well as the causes of the delay are lacking in the U.S. Specifically, we aim to identify patient factors and provider factors that contribute to delayed diagnosis of sarcoma.

  • Collection of Sarcoma Tissue Study Scottsdale/Phoenix, AZ

    The goal of this study is to create a comprehensive system of tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of sarcoma who will or have undergone a surgical procedure to remove the sarcoma.  The tissue samples will be used for future research of sarcoma at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.   

  • A Dose Escalation Study of HFB301001 in Adult Patients with Advanced Solid Tumors Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).

  • Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) in Adult Patients with Advanced Solid Tumors Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this two part study is to characterize the safety and tolerability of single agent HFB200301 and to determine RDE(s) and an RP2D.

  • A Study Evaluating MM-310 in Patients With Solid Tumors Rochester, MN

    MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1 open-label study of MM-310 in patients with solid tumors. In the first part of the study, MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established. After an MTD of MM-310 as a monotherapy is established, an expansion cohort and MM-310 in combination with other therapies will be assessed.

  • Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors Rochester, MN

    Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.

  • Mayo Clinic Cancer Genomics Service Line Biorepository Eau Claire, WI; Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The goal of the study is to create a database of clinical information and a repository of biological specimens for genetic, molecular and microbiological research to better understand hereditary cancer and help develop new therapies and preventive strategies.

  • A Phase 1/2 Study of CYT-0851, an Oral RAD51 Inhibitor, in B-Cell Malignancies and Advanced Solid Tumors Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of the oral RAD51 inhibitor CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose for evaluation in these patients.

  • Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.

  • "Prescribing" Exercise to Cancer Patients at High-Risk for Falls Rochester, MN

    Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls.

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