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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • 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
  • Chondrosarcoma
  • Fibrosarcoma
  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors
  • Hemangiopericytoma
  • Histiocytoma
  • Histiocytoma, Malignant Fibrous
  • Leiomyosarcoma
  • Liposarcoma
  • Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Osteosarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Alveolar Soft Part
  • Sarcoma, Ewing
  • Sarcoma, Synovial
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma

NCT number NCT00112463
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date January 2004

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