Active — Not RecruitingPhase 2

Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma

United States96 participantsStarted 2020-01-14

Plain-language summary

This phase II trial studies how well cabozantinib and temozolomide work in treating patients with leiomyosarcoma or other soft tissue sarcoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Cabozantinib 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 cabozantinib and temozolomide may work better than either one alone in treating patients with leiomyosarcoma or other soft tissue sarcoma. Cabozantinib is an investigational drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA) or any other regulatory agencies for sale or use by the public for the indication under investigation in this study.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have a histologically confirmed diagnosis of unresectable or metastatic: * Uterine and non-uterine leiomyosarcoma * Other soft tissue sarcoma (non-leiomyosarcoma) * Note: Subjects with any one of the following soft tissue sarcoma histological subtypes will not be eligible for participation: alveolar soft-part sarcoma, dermatofibrosarcoma, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, mixed mesodermal tumor/carcinosarcoma, rhabdomyosarcoma (embryonal and alveolar), and low grade (grade 1) sarcomas * Subjects must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Subjects with 0 - 5 prior chemotherapy regimens for recurrent/metastatic disease are eligible. It will be up to the investigator to determine what constitutes a regimen in each case * Subjects with prior next generation sequencing (NGS) reports completed on their tumor specimen will have this data collected * Subjects must have measurable disease by RECIST 1.1 * Subjects must have adequate organ and bone marrow function, based upon meeting all of the following laboratory: * White blood cell count \>= 2500/mm\^3 (\>= 2.5 GI/L) * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (\>= 1.5 GI/L) without granulocyte colony stimulating factor support * Hemoglobin \>= 9 g/dL (\>= 90 g/L) * Platelets \>= 100,000/mm\^3 (\>= 100 GI/L) without transfusion * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (for subjects with Gilbert's disease =\…

What they're measuring

Progression-free Survival (PFS)

Timeframe: After the first 12 weeks of therapy

Trial details

NCT IDNCT04200443

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-04

Results submitted2026-03-02