GENE THERAPY FOR BRAIN TUMORS USING ANTISENSE CDNA TRANSCRIPTION GROW

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The purpose of this phase I study is to identify toxicity and other risk associated with this IGF-I Antisense RNA gene therapy treatment. Twelve patients ages 18 and older with a confirmed histological diagnosis of glioblastoma multiforme will be recruited. The study is in progress. Three dose levels have been proposed: 10, 50, and 100million autologous, irradiated, and transfected glioblastoma multiforme cells. The study design includes three cohorts of 4 patients each. The first cohort of patients is to be treated at the lowest dose level. When it is satisfactorily determined that no major contraindications to progresssion of the study have occurred, the dose will be sequentially increased in the following cohorts. Each patient is to receive three subcutaneous injections at the time periods designated (Day 1, 4 weeks, and 12 weeks). For each individual patient, all three injections will be at the same dose of cells. The protocol was revised according to recommendations made by the University Hospitals Cancer Center Clinical Trials Committee. The amended protocol was approved by the IRB 4/20/98. Subsequent to that time, one patient has been recruited to this study.