Bladder Cancer
Conditions
Keywords
bladder cancer, BCG-resistant localized transitional cell of the bladder
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 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.
Interventions
DRUGBCG and CP-675,206
Dose level -1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 3 mg/kg I.V. week 3, week 15 Dose level 1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 6 mg/kg I.V. week 3, week 15 Dose level 2: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 10 mg/kg IV week 3, week 15 Dose level 3: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 15 mg/kg IV week 3, week 15
Sponsors
Pfizer
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses | 24 months |
| To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes | 24 months |
| To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses | 24 months |
| To determine the 1-year recurrence-free survival | 24 months |
| To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose | 24 months |
Outcome results
None listed