A randomized, open-label phase IIb study of maintenence therapy with a MUC-1 dendritic cell vaccine in patients with epithelial ovarian cancer in first or second remission.

TPS171 Background: MUC-1 is a highly immunogenic antigen that is widely expressed in epithelial ovarian carcinoma (EOC) making it an ideal target for vaccine therapy. Prior phase I and II studies conducted in Australia of the MUC-1 dendritic cell vaccine (CVac) in heavily pretreated, advanced disease patients showed minimal toxicities and prolonged disease stabilization. The purpose of this trial is to determine the safety and efficacy of a MUC-1 dendritic cell vaccine (CVac) in ovarian cancer patients who are in clinical remission after first or second-line therapy. Methods: Women with stage III or IV ovarian, fallopian tube, or primary peritoneal carcinoma who have had a complete response (CR) based on clinical and radiologic studies after first or second-line chemotherapy will be eligible for this study. Planned sample size is 60 patients. The first 6 patients will be treated with CVac open-label to ensure consistency of manufacturing. The next 54 patients will be randomized 1:1 to CVac or standard of ...