At a glance
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A Randomized, Prospective, Phase II Study to Determine the Efficacy of Bacillus Calmette-Guerin (BCG) Given in Combination With PANVAC[TM] Versus BCG Given Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer (NMIBC) Who Failed at Least 1 Induction Course of BCG
In Brief
A Phase 2 clinical trial evaluating BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)) and PANVAC for Bladder Cancer. Completed, enrolled 32 participants across 2 sites.
Detailed Summary
Background: \- Many cancers produce two particular proteins. The immune system can target these to attack the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the body sees the proteins as foreign invaders and attacks them. Researchers will test PANVAC on people with high grade non-muscle invasive bladder cancer. They will give it to people who have not responded to the usual treatment, bacillus Calmette-Guerin (BCG) over several weeks. They want to see if PANVAC plus BCG is better than BCG alone. Objective: \- To compare the effects of PANVAC plus BCG therapy, to BCG therapy alone. Eligibility: \- Adults 18 and older with high grade non-muscle invasive bladder cancer who failed at least 1 course of BCG. Design: * Participants will be screened with blood and urine tests and abdominal scans. * Participants will be randomly assigned to get BCG only or BCG plus PANVAC. * They will have up to 10 visits over 15 weeks. Most of these are part of usual cancer care. * They will have blood and urine tests. * All participants will get BCG in 6 weekly injections. * One group will also get PANVAC in 5 injections over 15 weeks. * Between weeks 17 and 20, participants will undergo tests of the tumor area as part of their usual care. They will have cystoscopy, exam under anesthesia, and bladder biopsy. Results will be used to evaluate the different treatments. * Participants will have quarterly follow-up visits for up to 2 years.
Study Details
Timeline
Interventions
TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).