This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of Reolysin given intravenously in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase II trial is to measure tumor responses and duration of response, and to describe any evidence of antitumor activity.
The secondary objective is to determine the safety and tolerability of Reolysin when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers.
Monica Mita, principal investigator of the study, said: “We are extremely pleased to open the second disease-directed study with Reolysin. This study represents a promising option for patients with head and neck tumors refractory to standard chemotherapy and we are happy to have the opportunity to offer this option to our patients.”