Adenovirus mediated wild type p53 gene therapy for gliom

University Of California San Francisco, San Francisco CA

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Abstract

This study is intended to provide an evaluation of the safety, tolerability, and feasibility of administering Ad-p53 by injection into the microscopic residual tumor surrounding a completely resected recurrent malignant glioma. The study is also intended to provide basic information about the biological effect of injecting Ad-p53 into human brain tumors in vivo. Consequently, patients will undergo two separate injections. The first (Stage 1) will be undertaken primarily to gain biological information and will involve stereotactic injection of Ad-p53 into the enhancing portion of the tumor as defined by post-gadolinium T1-weighted MR images. The second injection (Stage 2) will be undertaken primarily to evaluate clinical feasibility and toxicity of Ad-p53 and will involve open craniotomy three days later with en bloc resection of the previously injected tumor mass followed by injection of Ad-p53 into the walls of the resection cavity.