A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer

ENTRY CRITERIA: DISEASE CHARATERISTICS: * Histologically confirmed high-risk (high grade Ta, T1 or carcinoma in situ, tumor \>4 cm or multi-focal) transitional cell carcinoma s/p TURBT with no remaining resectable disease within 4 weeks of study entry * Intolerant of treatment with BCG or failure (refractory or relapsing) of at least one prior treatment with BCG * Refuse or intolerant of a radical cystectomy * No Evidence of regional and/or distant metastasis PRIOR/CONCURRENT THERAPY: * No concurrent radiotherapy, other chemotherapy, or other immunotherapy * No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation * Must have recovered from side effects of prior treatments * No concurrent use of other investigational agents PATIENT CHARACTERISTICS: Age • ≥ 18 years Performance Status • ECOG 0, 1, or 2 Bone Marrow Reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL * Platelets ≥ 100,000/uL * Hemoglobin ≥ 8 g/dL Renal Function • Glomerular Filtration Rate (GFR) ≥ 50mL/min Hepatic Function * Total bilirubin ≤ 2.0 X ULN * AST, ALT, ALP ≤ 3.0 X ULN Cardiovascular * No congestive heart failure \< 6 months * No severe/unstable angina pectoris \< 6 months * No myocardial infarction \< 6 months * No history of ventricular arrhythmias * No NYHA Class \> II CHF * No uncontrollable supraventricular arrhythmias * No history of a ventricular arrhythmia * No other clinical signs of severe cardiac dysfunction * No…