Results from a pivotal single-arm phase 2 trial shows that the repeated intratumoral administration of the oncolytic herpes virus G47∆ in residual or recurrent glioblastoma exhibits survival benefit and a safe profile NMEDClinical
MethodsThis investigator-initiated phase 2 trial was conducted at a single institution ) in Japan . The first patient enrollment date was 19 May 2015 and the last patient enrollment date was 18 April 2018. This study was approved by the PMDA on 29 August 2014. Under the guidance of the PMDA, it was recommended that this study be conducted at a single institution for safety reasons, as this was the first PMDA-supervised clinical trial of oncolytic virus therapy.
past or current medical history of any of the following: encephalitis, multiple sclerosis or other central nervous system infections; positive for human immunodeficiency virus; or conditions in which the use of MRI contrast media is contraindicated All patients enrolled in the trial provided written, informed consent. The protocol was approved by the institutional review board of the Institution of Medical Science, the University of Tokyo. Patients were not compensated for trial participation.
Radiation therapy was prohibited during the study. Steroid administration was permitted, but new doses or dose changes had to be recorded. Concomitant temozolomide was allowed, whereas other antineoplastic agents were prohibited. and approved by the PMDA. MRI data after administration of bevacizumab after disease progression were not used for the overall response rate evaluation.Complete response: two consecutive MRI scans performed at an interval of at least about 4 weeks show complete disappearance of a target lesion, with no appearance of new lesions.
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