Bladder Cancer Clinical Trial
Official title:
A Prospective Randomized Trial for the Comparison of Two BCG Strains (Bacille Calmette-Guerin) in the Prophylaxis of Papollary Bladder Tumors Stage Ta and T1 and Treatment of Carcinoma in Situ
Verified date | June 2019 |
Source | Swiss Group for Clinical Cancer Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system
and stop cancer cells from growing. It is not yet known which type of BCG is more effective
for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different types of
BCG in treating patients who have bladder cancer.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2010 |
Est. primary completion date | June 2001 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed completely resected T1 or Ta papillary
tumors of the urinary bladder TaG2 greater than 2 relapses in 2 years TaG3 unifocal or
multifocal Unifocal primary T1G2-3 after a histological tumor-free second resection If
multiple/multifocal, worst stage and grade AND/OR Histologically and cytologically
confirmed primary or secondary carcinoma in situ of the urinary bladder No persistent T1
disease in second resection No contracted bladder (bladder capacity less than 80 mL) or
bladder irritation within past 5 years No urothelial carcinoma of the upper urinary tract
or the urethra PATIENT CHARACTERISTICS: Age: 18 to 90 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Liver function no greater than 1.5 times upper limit of normal (ULN) Renal: Renal function no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No other concurrent malignancies except basocellular carcinoma No congenital or acquired immunosuppression (e.g., HIV, leukemia, lymphoma, transplant recipient) No uncontrollable or untreated urinary tract infection No chronic recurring bacterial cystitis PRIOR CONCURRENT THERAPY: Biologic therapy: No prior BCG therapy Chemotherapy: At least 3 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 5 years since prior radiotherapy to the bladder Surgery: See Disease Characteristics Other: No prior tuberculostatic therapy No concurrent local antiseptics or antibiotics |
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital, Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
Swiss Group for Clinical Cancer Research |
Switzerland,
Rentsch CA, Birkhäuser FD, Biot C, Gsponer JR, Bisiaux A, Wetterauer C, Lagranderie M, Marchal G, Orgeur M, Bouchier C, Bachmann A, Ingersoll MA, Brosch R, Albert ML, Thalmann GN. Bacillus Calmette-Guérin strain differences have an impact on clinical outc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess role of prior exposition to mycobacteria | 6 weeks | ||
Secondary | Define role of fever occurrence as potential indicator for BCG reactivity | 6 weeks |
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