Phase II multicenter study of gene mediated cytotoxic immunotherapy as adjuvant to surgical resection for newly diagnosed malignant glioma.

2010 Background: New therapies are desperately needed for malignant gliomas since aggressive standard of care (SOC) treatment with surgery, radiation, and temozolomide leads to median survival of less than 15 months. Gene Mediated Cytotoxic Immunotherapy (GMCI) generates a polyvalent anti-tumor immune response through local delivery of aglatimagene besadenovec (AdV-tk) plus prodrug, synergizing with SOC to improve patient outcomes. Methods: A Phase II open-label multicenter trial was designed to assess safety and overall survival (OS) after GMCI+SOC compared to a concurrent matched control group meeting protocol criteria and SOC at an institution not active in the treatment trial. AdV-tk was injected into the resection bed followed by oral valacyclovir for 14 days. Primary efficacy analysis was planned on the null hypothesis of no improvement in the 2-year survival over the SOC group with planned subset analysis of significant disease prognostic factors. Results: From 2006 to 2010, 48 patients completed S...