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

This is an interventional treatment trial for Bladder Neoplasms Read More

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.