A Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease
- 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
- 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of response (confirmed complete and partial)
From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
Daniel P. Petrylak, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government