Combined Use of BCG and Interferon Alpha in Bladder Cancer

Inclusion Criteria:

(1) Patients must have completely resected, histologically?proven urothelial carcinoma ofthe urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/orcarcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patientswith Stage Ta urothelial carcinoma must be judged to be at increased risk of tumorrecurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeksprior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade IIIurothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia orcarcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection. "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients whohave received prior intravesical therapy other than BCG were eligible provided they had notundergone a course of any other intravesical agent within two months prior to entry. (4)There was no age restriction; however, all patients registered had to be willing to beavailable for 5?year follow up and to have a life expectancy of at least two years. (5)Patients had a Karnofsky score >50. (6) Women of child?bearing age were using effectivecontraceptive methods. (7) Patients agreed not to take vitamin supplements (except forthose prescribed in the study) for the duration of the trial. (8) Pretreatment laboratorytests and radiological examinations must have been obtained during the 16 weeks prior topatient registration. (9) All patients had to be informed of the investigational nature ofthis study, and had to sign a written informed consent in accordance with institutionalguidelines.

Exclusion Criteria:

• (1) Patients with medical illness or mental status, which would preclude cooperationwith the study. (2) Patients who were immunodeficient, or had receivedimmunosuppressive radiation therapy or chemotherapy. (3) Patients with urothelialcarcinoma of stage T2 or higher. (4) Patients who had evidence of urothelial carcinomaof the upper urinary tract at the time of recruitment. (5) Patients who had receivedradiation therapy for bladder cancer within one year prior to registration. (6)Patients who had been previously treated with intravesical BCG. (7) Patients withactive tuberculosis.