Protocol 
CLINICAL RESEARCH PROJECT Date: 4 January, 1993 
TO: Recombinant DNA Advisory Committee 
Project Title: Gene Therapy for the Treatment of Recurrent 
Pediatric Malignant Astrocytomas with in vivo Tumor Transduction 
with the Herpes Simplex Thymidine Kinase Gene/ Ganciclovir System 
Identifying Words: gene transfer, retrovirus, pediatric brain tumor, 
malignant astrocytoma 
Co-Principal Investigators: 
Neurosurgery: Corey Raffel, M.D., Ph.D., Associate Professor 
Department of Neurosurgery, Childrens Hospital Los Angeles 
Gene Therapy : Kenneth Culver, M.D., Executive Director, 
Human Gene Therapy Research Institute, Des Moines Iowa 
Associate Investigators: 
Donald Kohn, M.D., Assistant Professor, 
Division of B.M.T., Childrens Hospital Los Angeles 
Marvin Nelson, M.D., Assistant Professor, 
Division of Radiology, Childrens Hospital Los Angeles 
Stuart Siegel, M.D., Professor and Chairman, 
Division of Hematology/Oncology, Childrens Hospital Los Angeles 
Floyd Gillis, M.D., Burton E. Green Professor, 
Division of Neuropathology, Childrens Hospital Los Angeles 
Charles J. Link, M.D., Associate Director, 
Human Gene Therapy Research Institute, Des Moines Iowa 
Judith G. Villablanca, M.D., Assistant Professor 
Division of Hematology/Oncology, Childrens Hospital Los Angeles 
Company Sponsor: 
Genetic Therapy Incorporated, Gairthersburg, M.D. 
Collaborators : 
W. French Anderson. M.D., Professor of Biochemistry and Pediatrics, 
University of Southern California School of Medicine 
Subject of Study Number Sex Range 
Patients 30 M or F 2-18 years 
Project Uses Ionizing Radiation: S 
Yes No 
Multi-institutional Project: ^ (Approvals secured) 
Yes No 
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Recombinant DNA Research, Volume 18 
