The primary objective of the trial is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of Reolysin when administered intratumourally to patients receiving radiation treatment. A secondary objective is to examine any evidence of anti-tumour activity. Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.
A total of 23 patients received a range of two to six intratumoural doses of Reolysin at escalating dosages up to a maximum of 1×10(10) TCID(50) with a constant localized radiation dose of either 20 Gy or 36 Gy. The treatment appears to have been well tolerated by the patients and results in both local and remote anti-tumour activity in patients with a variety of advanced cancers.
The trial enrolled patients at the Royal Marsden and St. James’s Hospitals in the UK.