Gastrointestinal Stromal Tumor Clinical Trial
Official title:
A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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