Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
National Cancer Institute
Participating centers:
Bethesda and New Brunswick
Accrual:
54
Study Design:
Phase 2, randomized trial comparing BCG alone to BCG and PANVAC in high-grade BCG-refractory NMIBC patients. The primary endpoint is 12 month DFS rate. The secondary endpoints are time to recurrence, progression-free survival, and immunologic correlates.
Rationale:
PANVAC is a vaccine with transgenes for CEA and MUC-1. These tumor antigens are overexpressed on the surface of high-grade urothelial tumors. Also PANVAC contains three co-stimulatory molecules that can augment a T-cell immune response. In theory, the vaccine should augment a T-cell response against cells expressing CEA and MUC-1. Therefore, it is postulated that it will augment the response to BCG when combined with BCG.
Comments:
An immune response can be triggered either by inhibiting blockade or augmenting T-cell stimulation. PANVAC attempts the latter with three co-stimulatory molecules. By using a systemic vaccine with a local immunotherapeutic agent, this trial attempts to establish greater efficacy than BCG alone.
