Markers of Response to Intravesical Bladder Cancer Therapy

Inclusion Criteria: Disease Characteristics: * Histologically confirmed primary or recurrent non-muscle-invasive transitional cell carcinoma with an intact bladder * Stage Ta, T1, or carcinoma in situ * Grade 1, 2, or 3 * Primary disease site must be the urinary bladder * No evidence of tumor invasion of the muscularis propria by cystoscopy and biopsy within the past 6 weeks * Upper tract imaging within the prior 12 months Patient Characteristics: * Age: 18 years and above * Gender: Male or female * Life expectancy: 24 months or greater * Performance status: 0 - 1 Prior Therapy: * Biologic therapy: allowed * Chemotherapy: allowed * Radiotherapy: no prior pelvic radiotherapy * Surgery: recovered from prior transurethral resection Intravesical Immunotherapy: * In the opinion of the treating physician, the patient must be a candidate for "standard of care" intravesical immunotherapy, defined as * Induction with 6 weekly treatments of intravesical BCG followed by maintenance with 3 weekly treatments of intravesical BCG at 3 months. Continued maintenance therapy at 6 months and then every 6 months for total of 36 months ("Lamm regimen") (38) is optional and left to the discretion of the physician or * Induction with 6 weekly treatments of intravesical BCG plus IFN-alfa-2b followed by maintenance with 3 weekly treatments of BCG plus IFN-alfa-2b at 3 months. Continued maintenance therapy at 9 months, and 15 months ("O'Donnell regimen") (39) is optional and left to the d…