Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer

Phase I Dose-escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) for Patients With BCG-resistant Localized Transitional Cell Carcinoma of the Bladder

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 bladder cancer after standard BCG treatment.

In addition, the study will look to see if taking CP 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.

Inclusion Criteria:

• 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 Criteria:

• 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