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

Sponsors and Collaborators:	University of Wisconsin, Madison Pfizer
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00880854

Purpose

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.

Condition	Intervention	Phase
Bladder Cancer	Drug: BCG and CP-675,206	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To determine the 1-year recurrence-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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	Drug: 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

Arms

Assigned Interventions

1: Experimental

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

Drug: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880854

Locations

United States, Wisconsin
University of Wisconsin Paul P Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Pfizer

Investigators

Principal Investigator:

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

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center ( Douglas McNeel, MD, PhD )
Study ID Numbers:	CO08807
Study First Received:	April 13, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00880854 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

bladder cancer
BCG-resistant localized transitional cell of the bladder

Study placed in the following topic categories:

BCG Vaccine
Urinary Tract Neoplasm
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Cytotoxic T-lymphocyte antigen 4

Carcinoma
Antibodies, Monoclonal
Antibodies
Urologic Diseases
Bladder Neoplasm
Immunoglobulins
Neoplasms, Glandular and Epithelial
Transitional Cell Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms

Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 04, 2009