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

University of Wisconsin (UW)

Status and phase

Withdrawn

Phase 1

Conditions

Bladder Cancer

Treatments

Drug: BCG and CP-675,206

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00880854

CO08807

SMPH/MEDICINE/MEDICINE*H (Other Identifier)

A534260 (Other Identifier)

H-2008-0227 (Other Identifier)

NCI-2011-03676 (Registry Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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