Phase I T rial o f I ntraperitoneal I njection o f t he E1B -55- kd-Gene-Deleted A denovirus O NYX-015 ( dl1520) G iven o n Days 1 T hrough 5 E very 3 W eeks i n P atients W ith Recurrent/Refrac tory E pithelial O varian C ancer

Purpose: Resistance to chemotherapy in ovarian cancer is frequently associated with mutations in the p53 gene. The adenovirus dl1520 (ONYX-015) with the E1B 55-kd gene deleted, allowing selective replication in and lysis of p53-deficient tumor cells, has shown preclinical efficacy against p53-deficient nude mousehuman ovarian carcinomatosis xenografts. Patients and Methods: We undertook a phase I trial of intraperitoneal dl1520 in patients with recurrent ovarian cancer. Sixteen women with recurrent/refractory ovarian cancer received 35 cycles (median, two cycles) of dl1520 delivered on days 1 through 5 in four dose cohorts: 1 10 9 plaque forming units (pfu), 1 10 10 pfu, 3 10 10 pfu, and 1 10 11 pfu.