Melanoma Clinical Trial
Official title:
Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable stage III or stage IV malignant melanoma.
OBJECTIVES: Primary - Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 (depsipeptide). Secondary - Determine the progression-free and overall survival of patients treated with this drug. - Determine the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive FR901228 (depsipeptide) 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. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 18 months. ;
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