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
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