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

NCT00880854

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bladder Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 22, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2009)
24
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00880854
Other Study ID Numbers  ICMJE CO08807
NCI-2011-03676 ( Registry Identifier: NCI Trial ID )
H-2008-0227 ( Other Identifier: Institutional Review Board )
A534260 ( Other Identifier: UW Madison )
SMPH/MEDICINE/MEDICINE*H ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Douglas G McNeel, M.D., Ph.D.University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date November 2019

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