CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
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What is sarcoma?
Most cancers are carcinomas, which start in the cells lining organs. Sarcomas start in the supporting tissues instead, and they split into two families. Soft tissue sarcomas, about 80 percent of cases, begin in fat (liposarcoma), smooth or skeletal muscle (leiomyosarcoma, rhabdomyosarcoma), blood vessels, nerves, or the lining of joints (synovial sarcoma), and they can appear almost anywhere, most often in the arms, legs, or abdomen. Bone sarcomas include osteosarcoma, the most common bone cancer in children and young adults, Ewing sarcoma, and chondrosarcoma. The usual first sign of a soft tissue sarcoma is a painless lump that keeps growing, often deep in a limb; bone sarcomas more often cause pain, especially at night, or a fracture from a minor injury. Most sarcomas have no known cause, though inherited syndromes, prior radiation, and certain gene changes raise risk.
Treatment is surgery first whenever the tumor can be removed, often with radiation, and chemotherapy for many bone sarcomas and high risk soft tissue types. Outcomes depend heavily on stage: five year survival for soft tissue sarcoma is about 66 percent overall, around 90 percent when the cancer is small and localized, and under 20 percent once it has spread. What makes sarcoma research different is the subtype problem. A drug that works in liposarcoma may do nothing in leiomyosarcoma, and each subtype is rare on its own, so trials are run by national groups such as the National Cancer Institute's cooperative networks at hundreds of sites at once. Recent progress has come exactly this way: in 2024 the FDA approved the first T cell receptor therapy for any solid tumor, for synovial sarcoma, and immunotherapy is now being tested in a Phase 3 trial for liposarcoma.
Our guide explains how clinical trials for cancer work.
Types of sarcoma clinical trials
Immunotherapy trials. Checkpoint inhibitors added to chemotherapy, now in Phase 3 for dedifferentiated liposarcoma, after years in which sarcomas were thought not to respond.
Cell therapy trials. CAR T cells and engineered T cell receptors aimed at proteins on sarcoma cells, mostly in children and young adults with relapsed disease; see CAR T cell therapy clinical trials.
Targeted therapy trials. Drugs matched to a subtype's biology: antibody drug conjugates for HER2 positive osteosarcoma, CDK4/6 inhibitors added to chemotherapy, and multi kinase inhibitors for bone sarcomas.
Chemotherapy sequencing trials. Whether giving chemotherapy before or after surgery is better, how to schedule it, and how to reduce heart toxicity from doxorubicin, including studies run remotely.
Pediatric trials. Studies for osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma, often shared between children's hospitals nationwide.
Survivorship studies. Programs for adolescents and young adults after treatment, when late effects and returning to work or school become the main concerns.
What is the newest sarcoma treatment?
The first T cell receptor therapy for a solid tumor, approved in 2024 for advanced synovial sarcoma. In trials, immunotherapy added to chemotherapy is in Phase 3 for liposarcoma, and CAR T cells are being tested in children with relapsed bone and soft tissue sarcomas.
Who can participate in sarcoma clinical trials?
Almost every sarcoma trial starts with the subtype, confirmed by a pathologist and often by genetic testing of the tumor, so a diagnosis of "sarcoma" alone is rarely enough. Trials then specify stage, usually localized and operable or metastatic, and treatment history, such as progression after doxorubicin. Cell therapy trials require a specific protein on the tumor and often enroll children and young adults from age 2 or 3 to their 30s. Pediatric trials have their own age bands, and many adult trials accept people from 12 or 18. Because trials are few for each subtype, many accept participants from across the country and help with travel. Eligibility always varies by study.
New to research? Read our guide to eligibility criteria, which in sarcoma often come down to your exact subtype.
How sarcoma is staged, and why it matters for trials
Localized (stage I to III). The tumor is in one place, graded by how fast its cells divide and by size. Surgery is the main treatment, and trials test chemotherapy or radiation before or after it. Five year survival for localized soft tissue sarcoma is around 90 percent for the earliest stage.
Metastatic (stage IV). Spread to the lungs, the most common site, or elsewhere. Five year survival falls below 20 percent, and this is where most drug, immunotherapy, and cell therapy trials recruit.
Recurrent. Cancer that has come back after treatment, often the target of early phase trials.
Study titles name the subtype first, then "metastatic," "unresectable," or "newly diagnosed," and often a marker such as HER2 or FGFR4. Your pathology report is the document that tells you which studies fit.
How to enroll in a sarcoma clinical trial
Identify your trial. Use the filters and search your subtype by name, for example "liposarcoma" or "osteosarcoma," as well as "sarcoma." Titles also state the stage and any required marker.
Select your preferred location. Enter your city or state, then widen the radius; sarcoma programs are concentrated at major cancer centers and children's hospitals.
Explore study details. Click "Learn More" for the exact subtypes accepted, prior treatments required or excluded, and whether a tumor sample is needed.
Complete the health profile. Click "Get started" to begin the 5-step application. Have three things ready: your subtype and grade from the pathology report, any tumor genetic results, and the treatments you have had.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.