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

This study has been withdrawn prior to enrollment.
(Lack of accrual)
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00880854
First received: April 13, 2009
Last updated: March 24, 2011
Last verified: March 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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: June 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 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

Other Names:
  • Bacille Calmette-Guerin (BCG)
  • Tremelimumab

  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

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: Douglas McNeel, MD, PhD, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00880854     History of Changes
Other Study ID Numbers: CO08807
Study First Received: April 13, 2009
Last Updated: March 24, 2011
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013