Intravesical BCG Administration to Patients With Invasive Bladder Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/8/2018 |
| Start Date: | November 2013 |
| End Date: | December 2020 |
Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment
response) BCG intravesically followed by a cystectomy.
response) BCG intravesically followed by a cystectomy.
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.
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.
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)
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