A phase I study of the infectivity enhanced CRAd Ad5-Δ24RGD for recurrent gynecologic cancer.

5107 Background: This report will focus on the translational studies completed in a phase I trial evaluating the MTD, toxicities, potential clinical activity, and biological effects of the infectivity enhanced tropism modified CRAd, Ad5-Δ24RGD, administered IP to patients with recurrent ovarian and other select gynecologic cancers. Methods: Cohorts of eligible patients were treated with Ad5-Δ24RGD daily × 3 via an IP catheter. Vector doses ranged from 1x10e9 viral particles/day (vp/D) to a maximum dose of 1x10e12 vp/D. Toxicity was evaluated utilizing CTC v3.0. CA-125 and RECIST criteria were utilized to determine clinical efficacy. Corollary biologic studies included assessment of CRAd replication, generation of wild type virus, viral shedding, and neutralizing antibody response. Results: Twenty-one patients were treated in 7 dose cohorts. No vector related G3/4 toxicities were noted and the MTD was not identified. Of the 19 patients with measurable disease, 14 had stable disease and 5 had progressive di...