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

NCT ID: NCT00880854

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

BCG and CP-675,206

Intervention Type: DRUG

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

Interventions

BCG 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

Intervention Type: DRUG

Other Intervention Names

Bacille Calmette-Guerin (BCG); Tremelimumab

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas G McNeel, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Related Links

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

NCI-2011-03676

Identifier Type: REGISTRY

Identifier Source: secondary_id

H-2008-0227

Identifier Type: OTHER

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/MEDICINE*H

Identifier Type: OTHER

Identifier Source: secondary_id

CO08807

Identifier Type: -

Identifier Source: org_study_id