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/1.73m^2

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
• Normal Transthoracic Echocardiogram (TTE) is required for patients who have history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or have history of having received adriamycin or doxorubicin
• No patients with a left ventricular ejection fraction (LVEF) of less than 50%

Pulmonary

• Normal clinical assessment of pulmonary function

Other

• Negative serum pregnancy test if female and of childbearing potential
• Women who are not 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 uncontrollable CNS disease
• 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