Sarcoma

Displaying 114 studies

  • Stereotactic Radiation Therapy for Pediatric Sarcomas Rochester, MN

    The SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in the adult population. However, SBRT (stereotactic body radiation therapy) has a particularly strong rationale for application in pediatrics given that high biologically effective doses have been shown to increase control in histologies, such as sarcoma, which are common in the pediatrics population (11,25). With stereotactic radiation therapy techniques, a reduction in normal tissue dose surrounding the target lesion of interest may also be accomplished resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with limited metastases in lung and bone, are still considered to be a ...

  • ROF2181 Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    Currently, only a few international institutions use CIRT to treat pelvic bone sarcomas. Accordingly, data evaluating the potential differences in oncological outcomes, toxicities, and functional outcomes between CIRT and the more readily accessible local therapies of surgery and PT is scarce. For this reason, we propose conducting a prospective comparative effectiveness study evaluating functional outcomes, toxicities, and local control in patients with pelvic bone sarcomas treated with surgery, PT, and CIRT.

  • A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors Jacksonville, FL; Rochester, MN

    The objectives of Phase 1 and Phase 2 of this study are to characterize the safety and tolerability of CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors.

    Phase 1 only: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for CFT8634 in subjects with locally advanced or metastatic SMARCB1-perturbed cancers.

    Phase 2 only: To assess preliminary antitumor activity by overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with locally advanced or metastatic synovial sarcoma (Cohort 1) or SMARCB1-null tumors (Cohort 2).

     

  • 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.

  • 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.

  • 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 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.

  • 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.

     

  • 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 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 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 ...

  • 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.

  • 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.

  • 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 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 Study of CMB305 and Atezolizumab in Patients with Sarcoma Jacksonville, FL; Rochester, MN

    The purpose of this study is to examine the use of CMB305 in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein.  CMB305 is a novel approach designed to stimulate the body's immune system to fight the spread and growth of cancer in patients whose tumors express the NY-ESO-1 protein.

  • YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or ...

  • 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 ...

  • 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.

  • Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma Jacksonville, FL; Rochester, MN

    This partially randomized phase I/II trial studies the side effects and best dose of sapanisertib and to see how well it works compared to pazopanib hydrochloride in treating patients with sarcoma that is too large to be removed (locally advanced) or has spread to other areas of the body (metastatic). Sapanisertib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

  • A Study to Collect Clinical Data and Store Samples of Blood and Tissue for Current and Future Research Studies on Sarcoma Jacksonville, FL; Scottsdale/Phoenix, AZ

    This study is being done to collect clinical data and store samples of your blood and tissue for current and future research studies on sarcoma.

  • 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.

  • Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL

    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 ...

  • Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young Rochester, MN

    The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).  

  • 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.

     

  • 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 ...

  • 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.

  • 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).

  • Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma Rochester, MN

    This randomized phase II trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, 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. It is not yet known whether combination chemotherapy is more effective ...

  • 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.  

     

     

  • 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 ...

  • 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 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 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.

  • Study to Evaluate the Safety, Tolerability and Preliminary Antitumor Activity of INCB059872 in Patients with Relapsed/Refractory Ewing Sarcoma Jacksonville, FL

    The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.

  • 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 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 ...

  • Spearhead 1 Study 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 Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS) Jacksonville, FL

    The purpose of this study is to compare the effectiveness and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory Leiomyosarcoma (LMS) who have received at least 1 prior line of systemic therapy.

  • 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.

  • Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma No Locations

    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.

  • 18F-DOPA PET in Sarcoma Patients Jacksonville, FL

    The purpose of this study is to identify early response biomarkers from biological or functional imaging to better align with clinical trial endpoints and minimize sarcoma patient toxicities.

     

     

  • 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.

     

  • 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.

  • 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 ...

  • Clinical Features, Prognostic Factors, Local Control Modalities, Survival, and Outcomes of Ewing Sarcoma in Pediatric and Adult Patients Rochester, MN

    The purpose of this study is to compare clinical features and outcomes for children and adults with Ewing Sarcoma at the same institution and add to the limited clinical literature on adults with Ewing Sarcoma.

  • 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 ...

  • 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, ...

  • 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 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.

  • Study of INBRX-109 in Conventional Chondrosarcoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

  • Alisertib in Treating Patients With Advanced or Metastatic Sarcoma Scottsdale/Phoenix, AZ; Rochester, MN

    This phase II trial studies how well alisertib works in treating patients with advanced or metastatic sarcoma. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

  • 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. 

     

  • 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 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).

  • Biomarkers in Sarcoma Rochester, MN

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

  • 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.

  • 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.

  • Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas Jacksonville, FL; Rochester, MN

    The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The safety of this drug combination will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

  • 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 ...

  • A Drug-drug Interaction Study of Avapritinib and Midazolam to Treat Unresectable or Metastatic Gastrointestinal Stromal Tumors and Other Advanced Solid Tumors Jacksonville, FL

    The purpose of this study is to investigate the effect of Avapritinib on the pharmacokinetics of Midazolam in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) or other advanced solid tumors.

  • 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).

  • Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the safety and tolerability of SP-2577 (seclidemstat) as a single agent and in combination with topotecan and cyclophosphamide (TC) in patients with relapsed or refractory Ewing sarcoma and select sarcomas.

     

  • 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 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.

  • 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 THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) Jacksonville, FL

    The purpose of this study is to assess the safety, effectiveness, and pharmacokinetics of THE-630 in participants with advanced gastrointestinal stromal tumors (GIST).

  • Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma Jacksonville, FL; Rochester, MN

    This study is evaluating whether administration of glucarpidase will allow faster clearance of high-dose methotrexate and thus fewer side effects related to methotrexate therapy.

  • 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

  • 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

  • An Early Access Program (EAP) for Avapritinib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL

    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.

  • 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 ...

  • 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.

  • 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.

  • (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.

  • 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 ...

  • 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 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.

  • A Study of Using Lorvotuzumab Mertansine in Treating Younger Patients with Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma No Locations

    The purpose of this study is to see how well lorvotuzumab mertansine works in treating younger patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab mertansine, are created by attaching an antibody (protein used by the body's immune system to fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to recognize tumor cells so the anti-cancer drug can kill them.

  • A Study to Determine the Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies Rochester, MN

    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 & ...

  • Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma No Locations

    This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as denosumab, may block tumor growth in different ways by targeting certain cells.

  • Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors No Locations

    This phase II trial is studying the side effects and how well cixutumumab works in treating patients with relapsed or refractory solid tumors. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

  • A Study to Evaluate Skin Angiosarcoma Imaging with Ultrasound Rochester, MN

    The purpose of this study is to to map out the extent of Skin Angiosarcoma disease using ultrasound. This will be compared to the MRI and or PET/CT and with clinical and photographic determination of disease extent confirmed with clinically requested punch biopsies. The patient will be scanned with a commercially avilable GE Logiq 10 machine and then with the 25-30 MHz linear microvessel transducer  for microvessel imaging. These scans will be obtained pretreatment, after 2 cylces of neoadjuvant chemotherapy and after completion of neoadjuvant chemotherapy and radiation therapy prior to surgery. 

  • Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma No Locations

    To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.

  • Alisertib in Treating Young Patients with Recurrent or Refractory Solid Tumors or Leukemia No Locations

    This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

  • Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors No Locations

    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.

  • 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 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 ...

  • (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.

  • 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.

  • 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.

  • 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.

  • 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).

  • Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1 Rochester, MN

    This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.

  • A Study of Intravital Microscopy (IVM) in Human Solid Tumors Jacksonville, FL

    The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.

  • Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1 Rochester, MN

    This is a Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1.

  • Undiagnosed Tumor/Undifferentiated Mass Registry Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to create a research registry to prospectively collect research biospecimens and corresponding clinical data from subjects with an undiagnosed tumor or undifferentiated mass.

  • Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma Rochester, MN

    The purpose of this study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma.

    Furthermore, to determine if open surgical resection is superior to thoracoscopy for event free survival (EFS), for overall survival (OS), and if thoracoscopy is superior to open surgical resection for postoperative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.

  • A Study of HFB200301 in Adult Patients With Advanced Solid Tumors Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.

  • Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors No Locations

    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 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 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.

  • 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.

  • 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.

  • cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR) Rochester, MN

    The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.

  • Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN

    The purpose of this study is to collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.

  • A Study to Evaluate Exercise for Cancer Patients at Risk of Falling Rochester, MN

    The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.

  • The Circulating Cell-free Genome Atlas Study Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

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