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.

Condition	Treatment or Intervention	Phase
stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder	Drug: BCG  Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  up to  85 Years,  Genders Eligible for Study:  Both

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

Austria
      Kaiser Franz Josef Hospital, Vienna,  A-1100,  Austria; Recruiting
Belgium
      Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels,  1090,  Belgium; Recruiting
      AZ Groeninge - Oncologisch Centrum, Kortrijk,  8500,  Belgium; Recruiting
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium; Recruiting
      Institut Jules Bordet, Brussels,  1000,  Belgium; Recruiting
      Onze Lieve Vrouw Ziekenhuis Aalst, Aalst,  B-9300,  Belgium; Recruiting
      Universitair Ziekenhuis Gent, Ghent,  B-9000,  Belgium; Recruiting
      Virga Jesse Hospital, Hasselt,  3500,  Belgium; Recruiting
France
      Hopital Edouard Herriot, Lyon,  69437,  France; Recruiting
      Hopitaux Universitaire de Strasbourg, Strasbourg,  67091,  France; Recruiting
Greece
      G. Hatzikosta General Hospital, Ioannina,  45001,  Greece; Recruiting
      University of Patras Medical School, Rio Patras,  GR-26500,  Greece; Recruiting
Israel
      Rabin Medical Center - Beilinson Campus, Petah-Tikva,  49100,  Israel; Recruiting
Italy
      Azienda Ospedale S. Luigi - Universita Di Turin, Orbassano, (Torino),  10043,  Italy; Recruiting
      Azienda Ospedaliera Maggiore Della Carita, Novara,  28100,  Italy; Recruiting
      Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino, Turin,  10126,  Italy; Recruiting
      Istituto Scientifico H. San Raffaele, Milano,  20132,  Italy; Recruiting
      Ospedale di Circolo e Fondazione Macchi, Varese,  21100,  Italy; Recruiting
      Ospedale Di Desio, Milan,  20033,  Italy; Recruiting
      Universita Degli Studi Di Pisa, Pisa,  56126,  Italy; Recruiting
      Universita Di Palermo, Palermo,  90145,  Italy; Recruiting
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands; Recruiting
      Amphia Ziekenhuis - locatie Langendijk, Breda,  4810 EV,  Netherlands; Recruiting
      Jeroen Bosch Ziekenhuis, 's-Hertogenbosch,  5211 NL,  Netherlands; Recruiting
      Leiden University Medical Center, Leiden,  2300 CA,  Netherlands; Recruiting
      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands; Recruiting
      Rijnland Ziekenhuis, Leiderdorp,  2350 CC,  Netherlands; Recruiting
      St. Franciscus Gasthuis, Rotterdam,  3045 PM,  Netherlands; Recruiting
      University Medical Center Nijmegen, Nijmegen,  NL-6500 HB,  Netherlands; Recruiting
      University Medical Center Rotterdam at Erasmus Medical Center, Rotterdam,  3000 CA,  Netherlands; Recruiting
Portugal
      Hospital Desterro, Amadora,  P-2700,  Portugal; Recruiting
Romania
      Institute of Oncology - Bucarest, Bucarest,  RO 72435,  Romania; Recruiting
Turkey
      Celal Bayar University, Manisa,  45010,  Turkey; Recruiting
      Dokuz Eylul University School of Medicine, Izmir,  35340,  Turkey; Recruiting
      Marmara University Hospital, Istanbul,  81190,  Turkey; Recruiting
United Kingdom, England
      Freeman Hospital, Newcastle upon Tyne,  England,  NE7 7DN,  United Kingdom; Recruiting
      Pontefract General Infirmary, Pontefract West Yorkshire,  England,  WF8 1PL,  United Kingdom; Recruiting
      St. James's University Hospital at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS9 7TF,  United Kingdom; Recruiting
United Kingdom, Scotland
      Gartnavel General Hospital, Glasgow,  Scotland,  G12 0YN,  United Kingdom; Recruiting

Study chairs or principal investigators

A. P.M. Van Der Meijden, MD, PhD,  Jeroen Bosch Ziekenhuis   

Study ID Numbers:  CDR0000065529; EORTC-30962; NCT00002990
Record last reviewed:  January 1999
Last Updated:  February 7, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002990
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08