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

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

 

Category: 
Central Nervous System Tumors
Session Type and Session Title: 
Clinical Science Symposium, Immunotherapy for Central Nervous System Tumors: Biomarkers and Novel Data
Abstract Number: 

2010

Citation: 
J Clin Oncol 33, 2015 (suppl; abstr 2010)
Author(s): 
Laura K. Aguilar, Lee A. Wheeler, Andrea G. Manzanera, Susan D. Bell, Robert Cavaliere, John M. McGregor, Simon Lo, John C. Grecula, Herbert B. Newton, Behnam Badie, Todd W. Trask, David S. Baskin, Jana Portnow, Pamela Z. New, Estuardo Aguilar-Cordova, E. Antonio Chiocca; Advantagene Inc, Auburndale, MA; Brigham and Women’s Hospital/Harvard Medical School, Boston, MA; Ohio State University, Columbus, OH; Ohio State University Wexner Medical Center, Columbus, OH; City of Hope, Duarte, CA; Houston Methodist, Houston, TX; Brigham and Women's Hospital/Harvard Medical School, Boston, MA

Abstract Disclosures

Abstract: 

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 SOC+GMCI and 134 SOC in the matched cohort. There were no dose-limiting toxicities. Fever, fatigue, and headache were the most common GMCI-related symptoms. Median OS increased by 3.6 months, from 13.5 for SOC to 17.1 months for GMCI+SOC (p = 0.0417). Survival at 1- 2- and 3-years increased from 57%, 22%, and 8% to 67%, 35%, and 19%, respectively. The improvement was mostly in patients that underwent gross total resection: median OS increased from 16.9 to 25 months (p = 0.0492); 1- 2- and 3-year survival rates from 64%, 28% and 6% to 90%, 53% and 32%. Conclusions: GMCI can be safely combined with SOC in newly diagnosed malignant gliomas. Survival rates compared favorably to historical reports and a matched control group. Survival outcomes were significantly improved in patients with minimal residual disease after total resection. The 2-year survival rate met the planned statistical threshold for significance. No significant differences were observed for subtotal resections. This is the first study to demonstrate a correlation between maximum debulking and a survival advantage using immunotherapy. These data strongly support further evaluation of GMCI for malignant gliomas. Clinical trial information: NCT00589875

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por cyto às 16:58



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