NCT00880854

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

April 13, 2009

Last Update Submit

November 13, 2019

Conditions

Bladder Cancer

Keywords

bladder cancerBCG-resistant localized transitional cell of the bladder

Outcome Measures

Primary Outcomes (1)

  • To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ

    24 months

Secondary Outcomes (5)

  • To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses

    24 months

  • To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes

    24 months

  • To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses

    24 months

  • To determine the 1-year recurrence-free survival

    24 months

  • To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose

    24 months

Study Arms (1)

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

Interventions

BCG and CP-675,206DRUG

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

Also known as: Bacille Calmette-Guerin (BCG), Tremelimumab
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Douglas G McNeel, M.D., Ph.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2011

Last Updated

November 15, 2019

Record last verified: 2019-11