Surgery and BCG in Treating Patients With Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer.

Detailed Description
-----------------
OBJECTIVES: Demonstrate that after complete transurethral resection of all papillary tumors, one third dose BCG (Bacillus Calmette-Guerin vaccine; OncoTICE) is equivalent to full dose BCG and short term maintenance is equivalent to long term maintenance with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up. Demonstrate that one third dose BCG and short term maintenance are associated with fewer local and systemic side effects. OUTLINE: This is a prospective randomized study. At 7-15 days after transurethral resection, patients will begin receiving one of the following four regimens: Regimen 1: One third dose Bacillus Calmette-Guerin (BCG) vaccine plus short term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12. Regimen 2: Full dose BCG plus short term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12. Regimen 3: One third dose BCG plus long term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30 and 36. Regimen 4: Full dose BCG plus long term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30, and 36. The patient is followed every 3 months for the first 3 years, and every 6 months thereafter. PROJECTED ACCRUAL: 1288 patients will be accrued for this study.

Official Title
-----------------
Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Biological: BCG vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the bladder of the following types: Multiple (not greater than 10), resectable, T1 or Ta, grade G1-G3 Solitary T1 GIII tumor PATIENT CHARACTERISTICS: Age: 85 and under Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Values used to evaluate function may not exceed two times the upper limit of normal Renal: Values used to evaluate function may not exceed two times the upper limit of normal Other: No second malignancy except basal cell skin carcinoma Not pregnant or nursing No uncontrollable urinary tract infection No active tuberculosis No HIV antibody No leukemia No Hodgkin's disease No transplant recipients PRIOR CONCURRENT THERAPY: Biologic therapy: No prior treatment with BCG Chemotherapy: No cytostatic agents within the past 3 months Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: BCG vaccine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose equivalency with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up |  |  | 
| Dose equivalency in terms of fewer local and systemic side effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder