Replication-competent Adenovirus-mediated Double Suicide Gene Therapy With Fractionated Stereotactic Radiosurgery in Progressive Glioblastoma: A Phase One Trial (S13.010)

We conducted a single site, nonrandomized, dose-escalation phase 1 trial of a replication competent novel adenovirus harboring two suicide genes (HSV-TK, yCD) and ADP expression cassette for treatment of adult patients with recurrent Glioblastoma (rGBM) undergoing repeat craniotomy followed by fractionated stereotactic radiosurgery (fSRS). The primary endpoints of this dose escalation study were to establish the maximum tolerated dose (MTD) and safety up to Day 90. Secondary endpoints were virus persistence, level of immunological cytokines, Quality of Life and overall survival (mOS).