FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Recruitment status was Active, not recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma|
- Response rate [ Designated as safety issue: No ]
- Progression-free and overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Estimated Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 (depsipeptide).
- 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) 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 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 18 months.
|Study Chair:||David H. Lawson, MD||Winship Cancer Institute of Emory University|
|Investigator:||Sanjiv S. Agarwala, MD||University of Pittsburgh|