Phase I study of intraperitoneal IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer administered in combination with pegylated liposomal doxorubicin in recurrent or persistent epithelial ovarian, Fallopian tube, or primary peritoneal cancer patients: An NRG/GOG study.

Abstract

5541 Background: EGEN-001 is an immunotherapeutic agent that comprises a human IL-12 plasmid that encodes for functional IL-12 and a synthetic DNA delivery system polyethyleneglycol-polyethyleneimine-cholesterol that facilitates plasmid delivery into cells. Ip injection of EGEN-001 is associated with increases in IL-12 levels and its downstream cytokines in the tumor environment without a significant increase in systemic circulation. The study’s purpose was to assess safety and efficacy of escalating doses of EGEN-001 with pegylated liposomal doxorubicin (PLD) in recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC) patients. Methods: Patient eligibility criteria: Females age ≥ 18 years with persistent or recurrent EOC. Patients were not required to have measurable disease and could have a biochemical recurrence; must have had one prior platinum-based chemotherapeutic regimen and up to two additional cytotoxic regimens; have adequate organ function. The trial was a ...