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.

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

This Phase 2 study will compare how well lenvatinib in combination with chemotherapy (Ifosfamide+etoposide) prevents disease progression, compared to chemotherapy alone. The study includes participants aged 2 to 25 years with recurrent/refractory osteosarcoma who have received no more than 2 prior systemic therapy regimens.

For more information on the study, please visit the following:


Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors

This is a Phase 1/2 study of lenvatinib in combination with everolimus in Recurrent and Refractory Pediatric Solid Tumors. Phase 1 includes participants aged 2 to 5 years with recurrent/refractory pediatric solid tumors. Phase 2 includes participants aged 2 to 21 years with recurrent/refractory Ewing Sarcoma, Rhabdomyosarcoma and High Grade Glioma. This study will measure how well the study drugs, lenvatinib and everolimus, block the growth of tumors in these cancer types; the primary endpoint is objective response rate at Week 16.

For more information on the study, please visit the following:


LSD1 inhibitor seclidemstat (SP-2577) in patients with relapsed/refractory Ewing sarcoma

This is an open label, single arm Phase 1 study to evaluate the safety of an orally administered targeted agent, seclidemstat (LSD1 inhibitor), in patients with relapsed or refractory Ewing sarcoma.  Patients must have received at least one prior course of therapy for Ewing sarcoma. Groups of patients will receive increasingly higher doses of seclidemstat (dose escalation phase) until the highest tolerated dose has been found.  Additional patients will then be enrolled at this highest tolerated dose (dose expansion phase). The primary objective is assessment of the safety and tolerability of seclidemstat.

For more information on the study and participating sites, please visit the following:


Vigil + Irinotecan and Temozolomide in Ewing’s Sarcoma (VITA)

This Phase 3 study of A) Vigil immunotherapy in combination with irinotecan and temozolomide vs. B) irinotecan and temozolomide, in subjects with Ewing’s sarcoma in First Relapse, who have failed one line of systemic chemotherapy (VITA study). The primary endpoint is progression-free survival. 

For more information, please visit the following:


ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma

The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG20), an extracellular arginine depleting enzyme, the investigators demonstrated ADI-PEG20 induces a prosurvival metabolic reprogramming in ASS1-deficient sarcomas that redirects glucose into the serine/folate pathway directing the carbons from glucose into pyrimidine biosynthesis, thus sensitizing cells to death by the pyrimidine antimetabolite gemcitabine by using metabolomics. The synthetic lethality was increased by the addition of docetaxel. Therefore a phase II clinical trial of ADI with gemcitabine and docetaxel, a standard second line therapy for soft tissue sarcoma will be conducted to determine if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by ADI-PEG20

For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03449901.  


Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer (NYESO SCT)

This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1 TCR (T cell receptor) engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after a myeloablative conditioning regimen to treat patients with cancer that has spread to other parts of the body. The conditioning chemotherapy makes room in the patient’s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer.

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03240861?term=NCT03240861&rank=1


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 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


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.    #STARTRK #NTRK1 #NTRK2 #NTRK3 #ROS1 #ALK #Ignyta #entrectinib


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


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

 


 

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