Non-Technical Abstract 
NON-TECHNICAL ABSTRACT 
The overall objective of this project is to perform a clinical trial in glioblastoma patients 
comprising injections of tumor cells genetically modified to secrete an immunostimulatory 
substance termed interleukin-2 (IL-2). The study will evaluate the safety, anti-tumor effects and 
immune responses induced by injections with escalated doses of the irradiated, genetically 
modified tumor cells. We have treated one patient with glioblastoma multiforme who had failed 
conventional therapy with IL-2 modified cells. No significant toxicity was noted at the injection 
sites and post treatment monitoring of blood and urine tests of organ function revealed no 
significant changes from pre-treatment values. Anti-tumor immune responses were observed 
during the course of therapy. This patient's tumor, termed GT9, will be utilized to inject other 
patients. In this study, a group of patients will be injected with their own irradiated tumor cells 
which have been genetically modified to secrete EL-2 and a second group of patients will be 
treated with IL-2 gene modified irradiated GT9 cells. Patient groups will receive injections with 
increasing doses of the genetically modified tumor cells. The patients will be monitored for 
toxicity, anti-tumor responses and the induction of anti-tumor immunity. The results of the trial 
should permit an assessment of the safety of this form of IL-2 gene transfer and provide initial 
data to evaluate the potential utility of IL-2 gene therapy in glioblastoma patients. 
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Recombinant DNA Research, Volume 19 
