Intravesical BCG Administration to Patients With Invasive Bladder Cancer

The University of Texas System (UT)

Status: Terminated

Conditions: Bladder Cancer

Treatments: Drug: BCG strain of Mycobacterium bovis

Study type: Interventional

Funder types: Other

Identifiers

NCT02365207

14-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

BCG treatment of invasive bladder cancer

Experimental group

Description:

Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

Treatment:

Drug: BCG strain of Mycobacterium bovis