Study Stopped
Poor accrual of subjects and lack of funding
Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
1 other identifier
interventional
6
1 country
1
Brief Summary
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2019
CompletedResults Posted
Study results publicly available
November 5, 2019
CompletedNovember 5, 2019
September 1, 2018
4.9 years
February 3, 2015
September 23, 2019
October 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
At cystectomy at 3-6 weeks after BCG treatment
Study Arms (1)
BCG treatment of invasive bladder cancer
EXPERIMENTALInvasive bladder cancer treated with 3-6 weeks of intravesical BCG
Interventions
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MARC - The University of Texas Health Science Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Svatek
- Organization
- University of Texas Health San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Svatek, MD
University of Texas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2015
First Posted
February 18, 2015
Study Start
November 1, 2013
Primary Completion
September 30, 2018
Study Completion
April 25, 2019
Last Updated
November 5, 2019
Results First Posted
November 5, 2019
Record last verified: 2018-09