SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Evaluating Local and Regional Immune Responses to 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


  • Org Study ID: 14-002
  • Secondary ID:
  • NCT ID: NCT02365207
  • NCT Alias:
  • Sponsor: The University of Texas Health Science Center at San Antonio - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: November 2013 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Ability of BCG to enhance tumor specific immunity

Primary Outcome 1 - Time Frame: At cystectomy at 3-6 weeks after BCG treatment

Condition:

  • Bladder Cancer

Eligibility

Criteria:
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 (
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)
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Robert Svatek, MD

Role: Principal Investigator

Affiliation: University of Texas

Overall Contact

Name: Robert Svatek, MD

Phone: 210-567-5676

Email: svatek@uthscsa.edu

Location

Facility Status Contact
MARC - The University of Texas Health Science Center
San Antonio, Texas 78229
United States
Recruiting