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

Pts must have histo conf TCC of the urothelial tract. Disease should be M1 and not curable by surgery or RT. Pts w/N+, non-metastatic disease that is unresectable are eligible. Disease must be measurable and assessed w/in 28 days prior to reg. Non-measurable disease must be assessed w/in 42 days prior to reg. Pts must have disease that progressed or recurred following ONE prior systemic chemo regimen including cisplatin or carboplatin for metastatic disease. Prior adjuvant therapy okay. 28 days must have lapsed from last chemo. Prior intravesical, RT or surgery allowed, but 28 days must have lapsed and pt must have recovered from any adverse effects of prior therapy. Pt must not have significant cardiac disease (see protocol Section 5.5). Pts w/LVH on EKG are not eligible. Pt must have WBC >/= 3000, ANC >/= 1500, PLT >/=100,000 w/in 14 days prior to reg. Pts must have bili </= IULN, SGOT or SGPT</= 2.5 x IULN, creat </= 2 x IULN w/in 14 days prior to reg. Pt mst have potassium >/= 4 mmol/L and magnesium >/= 2 mg/dL w/in 28 days prior to reg. Pt must not be taking or planning to take hydrochlorothiazide. Pt must be offered opportunity to consent for specimen submission. Pt must have Zubrod PS 0-2. Pts must not have rec'd prior depsipeptide and must not be rec'g any other inv agent or drug known to have histone deacetylase inhibitor activity such as sodium valproate. HIV+ pts rec'g comb anti-retroviral therapy are excluded. Pts w/known brain mets are not eligible. Pts must not have a hx of allergic reactions attributed to similar compounds. There must be no plans for pt to rec concurrent chemo, hormonal tx, RT, immunotherapy or any other type of tx for their cancer. Pts must not be pregnant or nursing and have agreed to use an effective contraceptive method. No other prior malignancy allowed.