FR901228 in Treating Patients With Unresectable Stage III or Stage IV 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma|
- Proportion of Patients With Response to Depsipeptide [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years ] [ Designated as safety issue: No ]
Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR).
Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
|Study Start Date:||January 2005|
|Study Completion Date:||March 2009|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
- 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) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104884
|Study Chair:||David H. Lawson, MD||Emory University|