Sarcoma Clinical Trials

The Sarcoma Foundation of America Clinical Trial Navigating Service

The Sarcoma Foundation of America Clinical Trial Navigating Service offers patients, caregivers and health care professionals up-to-date information about sarcoma cancer clinical trials throughout the United States and Canada. The service is provided in collaboration with EmergingMed and will help you quickly search for clinical trial options that match your specific diagnosis and treatment history.

This free and confidential service is designed to allow you to begin the search process online. However, we recommend that visitors begin the process by calling our toll-free number: 800-536-8718 or go to SFA Clinical Trial Navigating Service

Clinical Trials Resource Center

Welcome to the Sarcoma Foundation of America’s Clinical Trials Resource Center presented in partnership with CenterWatch.com, the leading publisher of information on clinical research for patients and their advocates. Please click on the links below to learn more about clinical research and new medical therapies.

Actively Recruiting Clinical Trials*

*for a comprehensive list, please go to the Patient Resource section at the bottom of the page.

Pembrolizumab and Doxorubicin Hydrochloride in Treating Patients With Sarcoma That is Metastatic or Cannot Be Removed by Surgery

This phase I/II trial studies the side effects and best dose of doxorubicin hydrochloride when given together with pembrolizumab and to see how well they work in treating patients with sarcoma that have spread to other parts of the body or that cannot be removed by surgery. Drugs used in chemotherapy, such as 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. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride together with pembrolizumab may work better in treating patients with sarcoma.  For more information, go to ClinicalTrials.gov.

A RANDOMIZED PHASE 3 TRIAL OF TRC105 AND PAZOPANIB VERSUS PAZOPANIB ALONE IN PATIENTS WITH ADVANCED ANGIOSARCOMA (TAPPAS)

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.  For more information go to ClinicalTrials.Gov

VIGIL® IMMUNOTHERAPY EWING’S SARCOMA CLINICAL TRIAL

VIGIL® is an investigational cellular Immunotherapy technology, designed to make a patient’s tumor cells more “visible” to their immune system, with the goal of enhancing the possibility of an immune response.VIGIL® Clinical Trials are underway in Ewing’s Sarcoma, Ovarian Cancer, Lung Cancer, Melanoma and Breast Cancer.  For more information go to the VIGIL website or ClinicalTrials.Gov

Selinexor in Advanced Liposarcoma (SEAL)

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 245 total patients will be randomized to study treatment (selinexor or placebo).  For more information

Study of ABI-009 in patients with advanced malignant perivascular epithelioid cell tumors (PEComa)

This phase 2 study will enroll approximately 30 patients with advanced (metastatic or locally advanced) malignant PEComa, who have not been previously treated with an mTOR inhibitor.

ABI-009 is a drug created using nanotechnology that binds rapamycin to a protein called human albumin. Rapamycin is classified as an “mTOR inhibitor” and blocks the activity of a protein called mTOR, which is known to be overactive in PEComa cancer cells. Rapamycin and similar types of therapeutics have been used in various other tumors, including advanced PEComas, but are not approved by the FDA for the treatment of PEComa. It is possible that the human albumin component of ABI-009 may allow rapamycin to reach cancer cells more effectively than rapamycin by itself. – For More Information including at ClincalTrials.gov

Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors

This phase 2 study will enroll patients of all tumor types, including sarcomas, who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the sarcoma to grow.  The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions in these cancers.   This study will measure how well and for how long LOXO-101 works.   Patients with a sarcoma who would not be able to receive any other options for treatment can participate in this trial.  If you are not sure if your cancer has one of these NTRK fusions, talk to your doctor about available options to have your tumor tissue tested. – For More Information

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (ANNOUNCE)

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. – For More Information

A Phase 1B Dose-escalation and Phase 2a Study of TRC105 in Combination With Pazopanib in Patients With Advanced Soft Tissue Sarcoma

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. Up to 18 patients will be treated.

The purpose of the phase 2 portion is to estimate the PFS of patients with advanced soft tissue sarcoma by RECIST 1.1 and estimate ORR in a separate cohort of patients with angiosarcoma by RECIST 1.1. Up to 76 patients will be treated in phase 2, including a cohort of up to 13 patients with angiosarcoma. – For More Information

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)

The Studies of Tumor Alterations Responsive to Targeting Receptor Kinases-2 (STARTRK-2) is a global, Phase 2 multi-site basket study designed to evaluate the clinical effectiveness and safety of entrectinib  (RXDX-101) as a targeted cancer therapy (ClinicalTrials.gov identifier NCT02568267). In Phase 1 trials, this once-daily, oral medication has demonstrated an overall response rate of 72% among patients with NTRK1, NTRK2, NTRK3, ROS1 or ALK gene rearrangements who were treated at or above the recommended Phase 2 dose level.  STARTRK-2 is currently enrolling patients with these gene rearrangements, which are present in some sarcomas.

For patients of any sarcoma subtype with unknown NTRK1, NTRK2, NTRK3, ROS1 or ALK gene rearrangement status, Ignyta’s CAP-accredited central diagnostic lab will perform testing on archival tumor tissue at no cost to patients.

If you’re unsure whether your sarcoma has one of these rearrangements, we encourage you to talk to your doctor and ask to get your tissue checked.  For more information, call 1-844-STARTRK (1-844-782-7875) or visit  www.startrktrials.com.  The website contains a valuable pdf discussion guide that will assist patients in discussing potential participation in the clinical trial with their medical oncologists.  #STARTRK #NTRK1 #NTRK2 #NTRK3 #ROS1 #ALK #Ignyta #entrectinib

A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma (NY-ESO-1)

The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma. – For More Information

A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

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 three cohorts based on tumor type:

  • Cohort 1: MRT, RTK, ATRT, or selected tumors with rhabdoid features
  • Cohort 2: Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement
  • Cohort 3: Other INI1 negative tumors, including: Epithelioid malignant peripheral nerve sheath tumor (EMPNST), Extraskeletal myxoid chondrosarcoma (EMC), Myoepithelial carcinoma,Other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma)
  • Cohort 4: Renal medullary carcinoma (RMC)
  • Cohort 5: Epithelioid sarcoma (ES)

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 8 weeks of treatment and then every 8 weeks thereafter while on study. – For More Infomation

Trial of CMB305 and Atezolizumab in Patients With Sarcoma (IMDZ-C232)

This is an open-label Phase 2 randomized study that will examine the use of the study agents, 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 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. LV305 will be given in a prime-boost approach with G305 to induce a potentially synergistic immunotherapeutic response in combination with atezolizumab. – For More Information

A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas

This research study is investigating a drug called PM01183 alone and in combination with chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic or unresectable Sarcoma. – For More Information

Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas

The investigators hypothesize that combination axitinib with pembrolizumab will improve progression-free survival relative to historical controls. – For More Information

A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma

Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface of most of these tumor types.

Two schedules of hu14.18K322A antibody will be evaluated in this study, (1) daily for four consecutive days schedule every 28 days and (2) once weekly for 4 weeks schedule every 28 days. Approximately 25-40 participants will be required to define the maximum tolerated dose for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or until one or more of the criteria for off-treatment are met. – For More Information

Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI)

The goal of this clinical research study is to compare rolapitant with fosaprepitant in controlling or preventing nausea and/or vomiting that may be caused by chemotherapy in patients with sarcoma. – For More Information

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing Sarcomas

Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma.

Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents. – For More Information

Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma

Background:

  • Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect, support, or surround other organs in the body. It relies heavily on new blood vessels to grow and spread through the body. There is no effective systemic treatment for patients with alveolar soft part sarcoma.
  • The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and Drug Administration. The drug blocks the creation of new blood vessels. The drug has had initial clinical trials, and researchers are interested in determining whether cediranib is effective in inhibiting tumor growth in individuals who have alveolar soft part sarcoma.

Objectives:

– To find out whether AZD2171 works in patients who have alveolar soft part sarcoma.

Eligibility:

– Individuals 18 years of age and older who have been diagnosed with alveolar soft part sarcoma.

Design:

  • After an initial screening visit, patients will take AZD2171 by mouth once a day, every day for the duration of the study. The treatment will be given in 28-day cycles.
  • Patients will keep a study diary to record the doses taken, any missed doses, and any side effects.
  • Patients will have the following tests and procedures during the treatment period: clinic visit with physical examination every 2 weeks, regular blood pressure monitoring, blood and urine tests, heart function tests, imagining scans to evaluate tumor size and response to the treatment, and possible tumor biopsy.

For More Information

13-C-0044 – A Phase 2 Study of Cabozantinib (XL184), a Dual Inhibitor of MET and VEGFR, in Pat

The National Cancer Institute is currently recruiting patients for participation in a Phase II study evaluating the effectiveness of cabozantinib for soft tissue sarcomas that have not responded to standard treatments. Cabozantinib, also called XL184, is a cancer treatment drug that blocks the growth of new blood vessels in tumors. It can also block a chemical on tumor cells that allows the cells to grow. A similar drug, pazopanib, is used to treat types of cancer known as sarcomas.  To learn more, please visit www.clinicaltrials.gov.

Sarcoma Alliance for Research through Collaboration (SARC)

SARC is a non-profit organization providing the infrastructure for collaboration between physicians, researchers, and medical institutions from across the world who are engaged in clinical research for development of new standards of patient treatment, education, and prevention. To find out more about SARC and a listing of our current clinical trials, please go to the SARC Trials Website.

Patient Resources

About Clinical Research
Background information about the clinical trials process and what to expect when you volunteer to participate in a clinical trial. Here, you’ll find answers to frequently asked questions about clinical trials and also suggestions for where to find more information.

CenterWatch Clinical Trials Listing Service
Database of industry sponsored clinical trial listings for Sarcoma.

Listing of Studies at ClinicalTrials.gov
Link to ClinicalTrials.gov, a comprehensive listing of federally and privately supported clinical trials. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with the Food and Drug Administration (FDA).

Profiles of Research Centers
Detailed descriptions of centers that conduct clinical research in the field of Oncology. Profiles include an overview of each center, descriptions of clinical research investigators and staff, and links to currently enrolling clinical research studies.

New FDA Drug Approvals
Database of new medical treatments approved by the FDA since 1995. Detailed summary descriptions for each drug are provided including drug name; manufacturer; mechanism of action; clinical trial results, and side effect profile.

CenterWatch Research Headlines
Here you’ll find links to news articles and reports on recent advances in clinical research. This section is updated weekly and the information has been published in CenterWatch publications during the past weeks.

CenterWatch Bookstore
Descriptions of all of CenterWatch’s publications for patients and for clinical research professionals.

Coalition of National Cancer Cooperative Groups
The Coalition’s website provides a wealth of information about cancer clinical trials. Website features include:

• TrialCheck, a clinical trials search engine
• Cancer Research: A Guide to Cancer Clinical Trials, an interactive educational program
•   Print materials for ordering
• Discussion with oncology experts
• Patient discussion forum

Clinical Trials search site
The NCI has developed this premier site.  Just type in osteosarcoma, soft tissue sarcoma, etc., or refine the search to your personal interests

CancerTrialsHelp.org
This site supplements the NCI site above a little bit, but is incomplete so should not be your sole search site

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