search
Back to results

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

Primary Purpose

Bladder Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BCG and CP-675,206
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, BCG-resistant localized transitional cell of the bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    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

    Outcomes

    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

    Secondary Outcome Measures

    To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses
    To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes
    To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses
    To determine the 1-year recurrence-free survival
    To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose

    Full Information

    First Posted
    April 13, 2009
    Last Updated
    November 13, 2019
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    Pfizer
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00880854
    Brief Title
    Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of accrual
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer
    Keywords
    bladder cancer, BCG-resistant localized transitional cell of the bladder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    BCG and CP-675,206
    Other Intervention Name(s)
    Bacille Calmette-Guerin (BCG), Tremelimumab
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses
    Time Frame
    24 months
    Title
    To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes
    Time Frame
    24 months
    Title
    To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses
    Time Frame
    24 months
    Title
    To determine the 1-year recurrence-free survival
    Time Frame
    24 months
    Title
    To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Douglas G McNeel, M.D., Ph.D.
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    https://cancer.wisc.edu/
    Description
    University of Wisconsin Carbone Cancer Center

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs