TABLE OF CONTENTS 
Face Page 1 
Abstract 2 
I. Bibliographical Information 5-25 
II. Research Plan 26 
A. Specific Aims and Hypothesis 26 
B. Introduction 26 
Clinical Background 26 
Malignant Glioma 26 
Pathologic Classification 26-27 
Research Background and Rationale for Study 27-28 
Tumor Immunology 28 
Previous Work with IGF-I and Glial Tumors 28 
Previous Human Experience with Gene Therapy in Cancer 29 
C. Study Design 29 
1. Specific Procedures 29-36 
Overview of Experimental treatment Plan 29-30 
Acquisition of Tissue, Tissue Culture and Transfection Techniques 30 
Acquisition of Human Tissue and Quality Control of Culture 30 
Human Glioma Primary Cell Culture Protocol 30-31 
Human Glioma Transfection Protocol 31-32 
Preparation of Transfected Tumor Cells for Reinjection 32 
Patient Procedures, Conventional Treatrment and Time Schedule 32 
Patient Groups 32 
Clinical Observations 32 
Neurologic Examinations 33 
Performance Ratings 33 
Laboratory Studies 33 
Radiologic Studies 33 
Other Studies 33 
Data Analysis 34 
2. Patient selection (population) 34 
Recruitment 34 
Number to be Studied 34 
Exclusion /inclusion criteria 35-36 
3. Justification 36 
4 Financial Considerations 36 
IV. Risks and Benefits 36 
Risk/ Benefit Ratio 36 
Precautions to Minimize Risks 36-38 
Monioring of Toxicity /Reporting of Adverse Reactions 38 
V. Justification of Study 38 
VI. Summary Scheme 39 
VII. References 40-44 
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Recombinant DNA Research, Volume 18 
