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Clinical Trial
. 2008 Mar;16(3):627-32.
doi: 10.1038/sj.mt.6300403. Epub 2008 Feb 5.

A phase I trial of intratumoral administration of reovirus in patients with histologically confirmed recurrent malignant gliomas

Peter Forsyth  1 , Gloria Roldán, David George, Carla Wallace, Cheryl Ann Palmer, Don Morris, Gregory Cairncross, Maureen Vallee Matthews, James Markert, Yancey Gillespie, Matt Coffey, Brad Thompson, Mark Hamilton
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Free article
Clinical Trial

A phase I trial of intratumoral administration of reovirus in patients with histologically confirmed recurrent malignant gliomas

Peter Forsyth et al. Mol Ther. 2008 Mar.
Free article

Abstract

Reovirus is an oncolytic virus with activity in in vivo models of malignant gliomas (MGs). The primary aims were to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intratumoral administration of reovirus in patients with recurrent MGs. Response, survival, and time to progression (TTP) were secondary aims. Patients were adults, had Karnofsky Performance score > or = 60, received prior radiotherapy with or without chemotherapy, and had up to the third recurrence of MG. Reovirus was administered intratumorally stereotactically at 1 x 10(7), 1 x 10(8), or 1 x 10(9) tissue culture infectious dose 50 (TCID50) in a volume of 0.9 ml. Twelve patients were treated at three dose levels (3, 6, and 3 patients, respectively). Seven were men, median Karnofsky Performance score was 80, and median age was 53.5 years. There were no grade III or IV adverse events (AEs) definitely or probably related to treatment. Ten patients had tumor progression, one had stabilization, and one was not evaluable for response. Median survival was 21 weeks (range, 6-234), and one is alive 54 months after treatment. Median TTP was 4.3 weeks (range, 2.6-39). An MTD was not reached. The intratumoral administration of the genetically unmodified reovirus was well tolerated using these doses and schedule, in patients with recurrent MG.

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