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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
October 4, 2005
Primary Completion Date
May 1, 2006
Completion Date
March 1, 2009
Last Updated
June 28, 2023
4
ACTUAL participants
Depsipeptide
DRUG
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
NCT05039801
NCT06066138
Data Source & Attribution
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