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

University of Wisconsin, Madison0 sitesJune 2009

ConditionsBladder Cancer

InterventionsBCG and CP-675,206

DrugsBCG and CP-675,206

Overview

Phase: Phase 1
Intervention: BCG and CP-675,206
Conditions: Bladder Cancer
Sponsor: University of Wisconsin, Madison
Primary Endpoint: To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

February 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

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

Arms & Interventions

1

BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 in combination with CP-675,206 I.V. week 3, week 1

Intervention: BCG and CP-675,206

Outcomes

Primary Outcomes

To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ

Time Frame: 24 months

Secondary Outcomes

To determine the 1-year recurrence-free survival(24 months)
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 a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose(24 months)