A "PRECISION MEDICINE" STRATEGY FOR RECURRENT GLIOBLASTOMA

Abstract

BACKGROUND: Despite years of intense clinical research and clinical trials, there are essentially no effective therapies proven to increase survival at the time of tumor progression in Glioblastoma. Multiple strategies, primarily focused on targeted single agent approaches, have failed for a number of reasons. Newer approaches and strategies are needed. METHODS: The Ivy Foundation Early Phase Clinical Trials Consortium took the strategy that an agnostic approach, using tumor tissue obtained prior to any treatment decisions and interrogated using an extensive molecular profiling paradigm could be the basis for an informed treatment decision based upon individual patient genotypes. The goal of the Consortium was to develop a protocol designed to define individualized patient treatments, using a specialized molecular tumor board, within a reasonable time from the date of surgery. RESULTS: After extensive discussion about methods, endpoints, and specific types of genomic testing, focusing on a whole genome approach, a feasibility trial was designed, ultimately allowing for treatment using up to 4 drugs from the entire USA FDA approved Pharmacopia. Tumor tissue obtained from the of the lesion and multiple image guided biopsies of regions surrounding the core are profiled, reported to the tumor board with specific drug recommendations, and a final report given to the treating physician. CONCLUSIONS: The clinical trial design and strategy will be discussed, including the primary and secondary aims, and the regulatory process involved to allow the trial to open. Early results will be presented. SECONDARY CATEGORY: n/a.