Intravenous Administration of REOLYSIN® in Combination with Cyclophosphamide for Pediatric Patients with Relapsed or Refractory Solid Tumors
In November 2010, Oncolytics announced that the Children's Oncology Group (COG) intended to conduct a Phase I trial of REOLYSIN® in combination with cyclophosphamide in pediatric patients with relapsed or refractory solid tumors. The study is being conducted in collaboration with the US National Cancer Institute (NCI) under its Clinical Trials Agreement with Oncolytics, with Oncolytics providing clinical supplies of REOLYSIN®.
The primary objectives of the trial include estimating maximum tolerated dose, and defining and describing the toxicities of REOLYSIN® and REOLYSIN® plus oral cyclophosphamide in this patient population. Secondary objectives include defining antitumor activity of REOLYSIN® within the confines of a Phase I study, evaluating the development of neutralizing antibodies to REOLYSIN® following intravenous administration of REOLYSIN® alone and in combination with cyclophosphamide, and assessing the biologic activity of REOLYSIN®.