A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer

ENTRY CRITERIA: DISEASE CHARATERISTICS: * Muscle invasive or metastatic urothelial cancer of bladder, ureters, renal pelvis, and urethra * Histologically or cytologically confirmed with a clinical plan that would potentially include cisplatin\* plus gemcitabine systemic therapy or with disease refractory to a first-line platinum-based therapy (as defined in the protocol). \* Does not apply to patients screened for Phase II expansion * Surgically incurable PRIOR/CONCURRENT THERAPY: * No concurrent radiotherapy, other chemotherapy, or other immunotherapy * Must have recovered from side effects of prior treatments * If prior Proleukin® treatment, must have had a clinical benefit * No use of other investigational agents within 30 days of start or concurrently PATIENT CHARACTERISTICS: Age * ≥ 18 years Performance Status * ECOG 0 or 1 Bone Marrow Reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL * Platelets ≥ 100,000/uL * Hemoglobin ≥ 10g/dL Renal Function * Glomerular Filtration Rate (GFR): * ≥ 50mL/min/1.73m\^2 for cisplatin-containing regimen * ≥ 40mL/min/1.73m\^2 for non-cisplatin-containing regimen Hepatic Function * Total bilirubin ≤ 1.5 X ULN * AST, ALT, ALP ≤ 2.5 X ULN, or ≤ 5.0 X ULN (if liver metastases exists) * PT INR ≤ 1.5 X ULN Cardiovascular * No congestive heart failure \< 6 months * No unstable angina pectoris \< 6 months * No myocardial infarction \< 6 months * No history of ventricular arrhythmias * No NYHA Class \> II CHF * Normal…