NCI-7853 was a single-arm, open-label Phase I study of systemic and intraperitoneal administration of REOLYSIN® monotherapy in patients with platinum-refractory, metastatic ovarian epithelial, peritoneal and fallopian tube cancers. Patients received a constant dose of intravenous REOLYSIN® on days 1 through 5 of each twenty-eight day cycle, as well as an escalating dose of intraperitoneal REOLYSIN® on days 1 and 2. Approximately 14 patients were enrolled. The primary objectives were safety, tolerability and maximum tolerated dose.
Results from the study providing evidence of viral targeting and replication in peritoneal and ovarian cancer cells after intravenous administration of REOLYSIN® to patients were presented at the 101st Annual American Association for Cancer Research (AACR) Annual Meeting in April 2010. The treatment was reported to be safe and well tolerated, with no dose-limiting toxicities observed.
The study was sponsored by the US National Cancer Institute (NCI).