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.