Conditions: Adult Alveolar Soft-part Sarcoma Adult Angiosarcoma Adult Epithelioid Sarcoma Adult Extraskeletal Chondrosarcoma Adult Extraskeletal Osteosarcoma Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Fibrous Histiocytoma Adult Malignant Hemangiopericytoma Adult Malignant Mesenchymoma Adult Neurofibrosarcoma Adult Rhabdomyosarcoma Adult Synovial Sarcoma Gastrointestinal Stromal Tumor Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Adult Soft Tissue Sarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the response rates of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.

II. To estimate the time to progression of metastatic or unresectable soft tissue sarcomas to single-agent depsipeptide.

III. To evaluate the scope and extent of acute toxicities associated with single-agent depsipeptide when given to patients with soft tissue sarcomas.

OUTLINE: This is a multicenter study.

Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

After completion of study treatment, patients are followed up every 2 months.

Arms:
arm 1: Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

Interventions: intervention 1: romidepsin
Intervention descriptions: intervention 1: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting.

Protocol document: