NCT00104884

FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Melanoma
• Melanoma

Interventions

Type	Name	Description
DRUG	Depsipeptide	Given IV

Timeline

• Start date: 2005-10-04
• Primary completion: 2006-05-01
• Completion: 2009-03-01
• First posted: 2005-03-04
• Last updated: 2023-06-28
• Results posted: 2016-03-02