The trial (REO 012) is an open-label, dose-escalating, non-randomized trial of Reolysin given intravenously with escalating doses of cyclophosphamide. A standard dose of Reolysin is administered intravenously over five consecutive days, while an intravenous dose of cyclophosphamide is administered three days before Reolysin treatment and continues through the course of the treatment cycle. The total number of patients studied will depend on the number of dose levels tested, but it is anticipated to be approximately 30 patients.
Eligible patients include those who have been diagnosed with advanced or metastatic solid tumors including pancreatic, lung and ovarian cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.
The primary objectives of the trial include determining the minimum effective immunomodulatory dose of cyclophosphamide to obtain successful immune modulation. Secondary objectives include determining the safety profile of the combination and gathering any evidence of anti-tumor activity.