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

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ClinicalTrials.gov Identifier: NCT00880854
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : April 14, 2009
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Wisconsin, Madison

April 13, 2009
April 14, 2009
October 2, 2015
June 2009
February 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00880854 on ClinicalTrials.gov Archive Site
  • To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses [ Time Frame: 24 months ]
  • To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes [ Time Frame: 24 months ]
  • To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses [ Time Frame: 24 months ]
  • To determine the 1-year recurrence-free survival [ Time Frame: 24 months ]
  • To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
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

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bladder Cancer
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
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
Intervention: Drug: BCG and CP-675,206
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
24
Not Provided
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00880854
CO08807
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Pfizer
Principal Investigator: Douglas G McNeel, M.D., Ph.D. University of Wisconsin, Madison
University of Wisconsin, Madison
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP