Clinical trial NCT00880854: Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Bladder Cancer
Keywords: bladder cancer
BCG-resistant localized transitional cell of the bladder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ
timeFrame: 24 months
Secondary outcomes:
measure: To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses
timeFrame: 24 months
measure: To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes
timeFrame: 24 months
measure: To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses
timeFrame: 24 months
measure: To determine the 1-year recurrence-free survival
timeFrame: 24 months
measure: To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Douglas G McNeel, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: