COG-ADVL1014 was a Phase I trial of REOLYSIN® in combination with cyclophosphamide in pediatric patients with relapsed or refractory solid tumours. Patients received REOLYSIN® on days 1 through 5 of each twenty-eight day cycle, with some patients also receiving cyclophosphamide on days 1 through 21. Twenty-nine patients were enrolled. 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 antitumour 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®.
Results from the study were published in the journal Pediatric Blood & Cancer in February 2015. The paper reported that there were no hematologic dose-limiting toxicities. The median time to clear reovirus viremia was 6.5 days.
The study was sponsored by the Children’s Oncology Group (COG), and conducted by the COG in collaboration with the US National Cancer Institute (NCI).