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

You may be eligible if

• 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 cardiac stress test required for subjects who are ≥ 50 years old, or have a history of EKG abnormalities, or have symptoms of cardiac ischemia or arrhythmia
• No uncontrolled hypertension
• Pulmonary
• Not receiving chronic medication for asthma
• Normal clinical assessment of pulmonary function
• Hematologic
• No evidence of bleeding diathesis or coagulopathy
• Other
• Negative serum pregnancy test if female and of childbearing potential
• No women who are pregnant or nursing
• Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
• No known autoimmune disease other than corrected hypothyroidism
• No known prior organ allograft or allogeneic transplantation
• Not HIV positive
• No active systemic infection requiring parenteral antibiotic therapy
• No ongoing systemic steroid therapy required
• No history or evidence of CNS disease (Controlled brain metastases treated with radiation therapy or surgery where the disease has been clinically stable for a period of a least 3 months before screening is allowed)
• No psychiatric illness/social situation
• No other illness that in the opinion of the investigator would exclude the subject from participating in the study
• Must provide informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations