Clinical trial NCT00474994
Conditions: Adult Malignant Fibrous Histiocytoma of Bone Desmoid Tumor Endometrial Cancer Ovarian Cancer Sarcoma Small Intestine Cancer
Keywords: chondrosarcoma recurrent osteosarcoma localized adult malignant fibrous histiocytoma of bone metastatic adult malignant fibrous histiocytoma of bone recurrent adult malignant fibrous histiocytoma of bone recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Kaposi sarcoma recurrent uterine sarcoma adult leiomyosarcoma adult malignant fibrous histiocytoma adult rhabdomyosarcoma dermatofibrosarcoma protuberans stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma ovarian sarcoma uterine leiomyosarcoma stage III uterine sarcoma stage IV uterine sarcoma desmoid tumor adult angiosarcoma recurrent adult soft tissue sarcoma uterine carcinosarcoma endometrial stromal sarcoma fibrosarcomatous osteosarcoma chondrosarcomatous osteosarcoma adult alveolar soft-part sarcoma adult epithelioid sarcoma adult extraskeletal chondrosarcoma adult extraskeletal osteosarcoma adult fibrosarcoma adult malignant hemangiopericytoma adult malignant mesenchymoma adult neurofibrosarcoma adult synovial sarcoma adult desmoplastic small round cell tumor adult liposarcoma anaplastic osteosarcoma mixed osteosarcoma small intestine leiomyosarcoma osteoblastic osteosarcoma telangiectatic osteosarcoma classic Kaposi sarcoma immunosuppressive treatment related Kaposi sarcoma AIDS-related Kaposi sarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-04-01; Completion date: 2010-11-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent sarcomas.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent non-gastrointestinal stromal tumor sarcomas treated with sunitinib malate.

Secondary

* Determine the 16- and 24-week progression-free survival rate (complete response, partial response, and stable disease) in patients treated with this drug.
* Determine the overall survival in patients treated with this drug.
* Correlate clinical response with changes in soluble angiogenesis mediator levels in patients treated with this drug.
* Determine the tumor maximum standardized uptake values by fludeoxyglucose F 18-PET scan in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified by neoplastic subtype (vascular connective tissue neoplasms, leiomyosarcoma, dermatofibrosarcoma protuberans, chordoma, or desmoid tumors vs high-grade undifferentiated pleomorphic sarcoma \[i.e., malignant fibrous histiocytoma (including myxofibrosarcoma)\], or other nongastrointestinal connective tissue tumors \[including carcinosarcomas\]).

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Arms: arm 1: Vascular connective tissue neoplasms, leiomyosarcoma, dermatofibrosarcoma protuberans (DFSP), desmoid tumors. Sunitinib 37.5 mg daily continuously; one cycle is 28 days. Restaging: after every 2 cycles until after 6 cycles, when restaging will be decreased to once every 3 cycles. arm 2: High grade undifferentiated pleomorphic sarcoma (includes the older designation malignant fibrous histiocytoma \[MFH\]) and other non-GIST connective tissue tumors; may include carcinosarcomas.Sunitinib 37.5 mg daily continuously; one cycle is 28 days. Restaging: after every 2 cycles until after 6 cycles, when restaging will be decreased to once every 3 cycles. arm 3: Chordomas. Sunitinib 37.5 mg daily continuously; one cycle is 28 days. Restaging: after every 2 cycles until after 6 cycles, when restaging will be decreased to once every 3 cycles.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: None

Protocol documents: