Status:
WITHDRAWN
Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Pfizer
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial ...
Eligibility Criteria
Inclusion
- Histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical BCG.
- Evidence of disease recurrence within 1 year of previous BCG treatment
- Tumor tissue must be available from biopsy for study related immunohistochemical analysis
- If sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment
- ECOG performance status of \<2
- Life expectancy of at least 6 months
- Adequate hematologic, renal and liver function
- Informed consent
Exclusion
- No evidence of immunosuppression or treated with immunosuppressive therapy within 6 months
- No prior radiation to the pelvis
- No gross hematuria within 1 week prior to planned week 1 treatment
- Cannot have previous intolerance to BCG
- Cannot be seropositive for HIV, hepatitis B(HBV) or hepatitis C(HCV) per patient history
- No evidence of metastatic disease
- No prior treatment with anti-CTLA-4 monoclonal antibody
- Can not be pregnant or lactating
- No history of autoimmune disorder
- No history of thyroid or adrenal insufficiency
- No history of inflammatory bowel conditions, including diverticulitis, ulcerative colitis, Crohn's or celiac disease, intractable urinary tract infection
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00880854
Start Date
June 1 2009
Last Update
November 15 2019
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