Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Not Applicable

Terminated

• Conditions: Bladder Cancer
• Interventions: Drug: BCG strain of Mycobacterium bovis

• Registration Number: NCT02365207
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Status Verified: 2018-09
• Primary Completion: 2018-09-30
• Study Completion: 2019-04-25
• Results First Submitted: 2019-09-23
• Results First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-17
• Results First Posted: 2019-11-05
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Have suspected or known invasive (≥T1) bladder cancer
2. Be able to give informed consent
3. Be age 18 or older
4. Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)

Exclusion Criteria

1. Have non-invasive (<T1) bladder cancer
2. Unable to give informed consent
3. < 18 or older
4. Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCG treatment of invasive bladder cancer	BCG strain of Mycobacterium bovis	Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

Primary Outcome Measures

Name	Time	Method
Ability of BCG to Enhance Tumor Specific Immunity	At cystectomy at 3-6 weeks after BCG treatment	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

Trial Locations

Locations (1)

MARC - The University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States