Clinical Trials

The purpose of this study is to assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.

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.

Sarcomas are rare, encompass multiple subtypes, and have few established guidelines. Geriatric assessments and screening tools are recommended as part of multi-disciplinary care for older patients with cancer, but they are not widely used in clinical practice. This pilot study will prospectively evaluate older patients (age 65 years and above) with sarcoma who are followed in the medical oncology sarcoma clinic in Rochester MN; this will include patients who are newly diagnosed or receiving systemic therapy. Patients will undergo geriatric screening as well as laboratory testing. Laboratory testing will include routine complete blood counts (CBC) that are associated ...

The purpose of this study is to evaluate the use of ICG as an intraoperative guide during bone and soft tissue sarcoma resection to determine if ICG fluorescence will be an accurate, real-time, intraoperative margin detector during resection of musculoskeletal sarcomas.

The purpose of this study is to create a process for the retrieval, processing, analysis and maintenance of post-mortem sarcoma tissue. Deceased patients likely harbor some of the most aggressive types of cancer since maximal treatment has failed. Why some of these patients fail standard treatment while others don’t remains unknown.  Our aim is to study these very aggressive types of cancer by collecting and analyzing post-mortem tumor tissue samples. These samples will also be stored for future research. The long-term objective is to expand these processes to all sarcomas and increase the number of participating institutions to allow for a ...

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.

The purpose of this study is to evaluate the association between tumor characteristics assessed by contrast-enhanced MRI and location with presence of circulating tumor DNA (ctDNA) in patients with localized, high-grade leiomyosarcoma [Time Frame: 2 years ].

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.

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).  

The goal of this clinical trial is to learn about the safety of drug [Ac225]RTX-2358 and the diagnostic imaging agent [Cu64]LNTH-1363S. Additionally Ratio Therapeutics will learn if [Ac225]RTX-2358 drug is effective in treating advanced sarcoma.

The main questions the study aims to answer in Phase/Part 1 of the trial are:

• Is [Ac225]RTX-2358 tolerable or does it cause toxicities (medical problems) in patients.

• What is the most tolerable dose of [Ac225]RTX-2358

• Does the treatment show effectiveness on advanced sarcoma

Participants will:

• Take drug [Ac225]RTX-2358 once every 8 weeks (4 cycle target; 6 cycle maximum) over a period of 12 months

• Visit the clinic three times for the first ...

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 ...

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 ...

The purpose of this study is to compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

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.

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 ...

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.

The purpose of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades ...

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

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 ...

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

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, ...

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.

    

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

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.

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .

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.

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.

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.

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 ...

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).

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 ...

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

The purpose of thist study is to find a cost effective CV surveillance of cancer survivors over long periods of time to prevent the risk of progression of HF and related morbidity and mortality. Mobile device-based AI-ECG can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors  and smart watch based surveillance for cardiotoxicity is feasible and reliable.

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.

The purpose of this study is to compare the objective response rate (ORR) by IRR of ripretinib vs sunitinib using modified Response Evaluation Criteria in Solid Tumors v1.1 – GIST-specific (mRECIST). Also, to compare the overall survival (OS) of ripretinib vs sunitinib.

The purpose of this study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.

The primary objectives of this study are to examine the correlation of change in ctDNA with objective tumor response per Response Evaluation Criteria in Solid Tumors (RECIST), and to examine the correlation of change in ctDNA with progression free survival (PFS).

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.

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. 

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).

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.

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.

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.

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.   

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.

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 ...

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.

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.

The purpose of this study is to validate a non-invasive diagnostic test with both high-sensitivity and negative predictive value (NPV) for its ability to rule out endometrial cancer.

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.

The purpose of this study is to demonstrate 1) feasibility of digital biomarker assessment using wearable in children with solid tumors who undergo surgery and 2) alterations in circulating proteins and metabolites indicative of a stressed state will persist postoperatively and correlate with clinical signs of recovery.

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.

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.

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.

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.

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.