Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

A. P.M. Van Der Meijden, MD, PhD

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002990
Information obtained from ClinicalTrials.gov on December 21, 2011

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