Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02365207
• Other study ID #: 14-002
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Est. completion date: April 25, 2019

Study information

• Verified date: September 2018
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 25, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• BCG strain of Mycobacterium bovis
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

Locations

Country	Name	City	State
United States	MARC - The University of Texas Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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