A Safety and Tolerability Study of SCH 721015 in Patients With Transitional Cell Carcinoma of the Bladder (Study P03816)

Inclusion Criteria: * Histologically proven recurrent transitional cell carcinoma of the bladder, Stage Tis, Ta. * Patients with recurrent T1 disease who do not wish to have cystectomy. * Subjects must have failed at least two prior courses of BCG with or without recombinant interferon alpha administration. * At least 3 months must have passed since last intravesical treatment for bladder carcinoma. * Subjects must be 18 years of age or older. * Life expectancy of at least 3 months. * Adequate performance status (Karnofsky score \>=70%). * Adequate laboratory values. Exclusion Criteria: * Suspected hypersensitivity to interferon alpha. * Subjects with organ transplants. * Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as: * History of psychosis or presence of poorly controlled depression; * CNS trauma or active seizure disorders requiring medication; * Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months; * Poorly controlled diabetes mellitus (HbA1C \>10.0%); * Unstable chronic pulmonary disease requiring hospitalization or emergency room visit within the last 3 months; * Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis). * History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration. * Untreated bladder infection. * Positive for hepatitis BsAg or HIV Ab or hepatitis C. * Immunosuppressive therapy within the last 3 months. * BCG therapy or intravesical therapy within 3 months. * Traumatic catheterization within 1 month.