Back to resultsIntravesical BCG Administration to Patients With Invasive Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BCG strain of Mycobacterium bovis
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
- Have suspected or known invasive (≥T1) bladder cancer
- Be able to give informed consent
- Be age 18 or older
- Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Exclusion Criteria:
- Have non-invasive (<T1) bladder cancer
- Unable to give informed consent
- < 18 or older
- Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Sites / Locations
- MARC - The University of Texas Health Science Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BCG treatment of invasive bladder cancer
Arm Description
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
Outcomes
Primary Outcome Measures
Ability of BCG to Enhance Tumor Specific Immunity
The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10
Secondary Outcome Measures
Full Information
NCT ID
NCT02365207
First Posted
February 3, 2015
Last Updated
October 17, 2019
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT02365207
Brief Title
Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Official Title
Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual of subjects and lack of funding
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
April 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
Detailed Description
Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.
After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCG treatment of invasive bladder cancer
Arm Type
Experimental
Arm Description
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
Intervention Type
Drug
Intervention Name(s)
BCG strain of Mycobacterium bovis
Other Intervention Name(s)
BCG
Intervention Description
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
Primary Outcome Measure Information:
Title
Ability of BCG to Enhance Tumor Specific Immunity
Description
The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10
Time Frame
At cystectomy at 3-6 weeks after BCG treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have suspected or known invasive (≥T1) bladder cancer
Be able to give informed consent
Be age 18 or older
Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Exclusion Criteria:
Have non-invasive (<T1) bladder cancer
Unable to give informed consent
< 18 or older
Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Svatek, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
MARC - The University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intravesical BCG Administration to Patients With Invasive Bladder Cancer
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