Combined Use of BCG and Interferon Alpha in Bladder Cancer
Combined Use of BCG and Interferon Alpha in Bladder Cancer
To compare the toxicity and efficacy of the combination of BCG and interferon alpha to
 standard dose and low dose BCG alone in high risk superficial bladder cancer
140 eligible patients with high risk superifical bladder cancer would be randomised to
 receive standard dose BCG, low dose BCG or the combination of low dose BCG and interferon
 alpha in a schedule of "6+3" weekly intravesical instillations. Patients would be closely
 monitored with cystoscopy and urine cytology and intravenous urograms when indicated. Pre-and
 post-instillation urine samples would be collected for cytokine analysis.
Inclusion Criteria:

 (1) Patients must have completely resected, histologically?proven urothelial carcinoma of
 the urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/or
 carcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patients
 with Stage Ta urothelial carcinoma must be judged to be at increased risk of tumor
 recurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeks
 prior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade III
 urothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia or
 carcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection.
 "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients who
 have received prior intravesical therapy other than BCG were eligible provided they had not
 undergone 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 be
 available 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 effective
 contraceptive methods. (7) Patients agreed not to take vitamin supplements (except for
 those prescribed in the study) for the duration of the trial. (8) Pretreatment laboratory
 tests and radiological examinations must have been obtained during the 16 weeks prior to
 patient registration. (9) All patients had to be informed of the investigational nature of
 this study, and had to sign a written informed consent in accordance with institutional
 guidelines.

 Exclusion Criteria:

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