RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen.
OBJECTIVES: * Determine the response (confirmed complete and partial) in patients with advanced transitional cell carcinoma of the urothelium that has progressed after prior chemotherapy when treated with FR901228 (depsipeptide) . * Determine progression-free and overall survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Determine, preliminarily, the effects of this drug on reversing tumor promoter gene methylation in these patients. * Correlate, preliminarily, tumor DNA in plasma with response or outcome in patients treated with this drug. 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. Patients achieving a complete response receive 2 additional courses of treatment. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Depsipeptide wil be given 13 mg/m\^2 through an intravenous (IV) over 4 hours on day 1, 8, and 15 for every 28 days (1 cycle = 28 days) until progression. Patients achieving a complete response (CR) will receive two additional cycles of treatment, and then be removed from protocol treatment.
Probability of response (confirmed complete and partial)
Time frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
Progression-free survival
Time frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
Overall survival
Time frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
Number and grade of adverse events
Time frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
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