Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
Background: * Gliosarcoma and primary central nervous system (CNS) sarcomas are malignant brain tumors uniformly associated with poor outcome. * There are no known effective medical therapies for these cancers. * Sunitinib is an orally administered small molecule that inhibits signaling of multiple receptor tyrosine kinases including those known to be activated in CNS sarcomas. Objectives: To determine the anti-tumor effect of sunitinib in recurrent gliosarcomas and primary CNS sarcomas as assessed by objective response rate (ORR). Eligibility: * Patients with histologically proven gliosarcoma and primary CNS sarcoma at disease relapse after failing standard therapy (surgery and irradiation). * Tumor tissue blocks or 15 unstained slides should be available * Subjects must be greater than or equal to 18 years old. * Karnofsky performance status of greater than or equal to 60 * Patients must have adequate organ function. * Patients must not have received tyrosine kinase inhibitor(s) in the past. Design: * This is a prospective, single institution, single arm, multi-cohort phase II study of sunitinib in subjects with recurrent gliosarcoma and primary CNS sarcoma that have failed prior surgery and irradiation (unless radiation therapy was contraindicated). * Subjects will be classified into three cohorts: 1) Primary gliosarcoma; 2) Secondary gliosarcoma; 3) Primary CNS sarcoma. Cohort expansion will be carried out at indication of promising response. * Sunitinib will be administered orally using a continuous schedule at 50 mg per day (with dose adjustments allowed for toxicity) for 2 weeks with 1 week off to constitute a 3-week cycle until disease progression or development of intolerable side-effects. * Toxicity will be assessed every cycle by Common Terminology Criteria in Solid Tumors (CTCAE) version 5.0.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
