CNS 18 - 2 
TABLE OF CONTENTS 
ELIGIBILITY CHECKLIST 4 
1.0 OBJECTIVES 5 
2.0 BACKGROUND 5 
2.1 Precis 5 
2.2 Clinical Background 6 
2.3 Proposed Retroviral vector-mediated Treatment of Human Brain 
Tumors 6 
2.4 Preclinical Retroviral HS-tk Gene Therapy Studies 8 
3.0 DRUG, VECTOR, GENE, PRODUCER CELL LINE INFORMATION 9 
3.1 Ganciclovir (GCV, Cytovene) 9 
3.2 The GITKSVNa Retroviral Vector 10 
3.3 HS-tk Gene 10 
3.4 Producer Cell Line 10 
4.0 ELIGIBILITY CRITERIA 11 
4.1 Inclusion Criteria 11 
4.2 Exclusion Criteria 12 
5.0 STUDY DESIGN AND TREATMENT 12 
5.1 Volume and Number of Injected Cells 12 
5.2 Peri-Operative Medications 12 
5.3 Ganciclovir sodium 13 
5.4 Supportive and Concurrent Care 14 
6.0 REQUIRED STUDIES 15 
6. 1 Neuroimaging Evaluation 16 
6.2 Yearly Follow-up Laboratory Evaluation 16 
6.3 Autopsy 16 
7.0 EVALUATION CRITERIA 16 
8.0 TOXICITY MONITORING 16 
9.0 OFF STUDY CRITERIA 17 
10.0 STATISTICAL ANALYSIS 17 
11.0 DATA MANAGEMENT/REPORTING REQUIREMENTS 17 
12.0 REFERENCES 18 
PROTOCOL APPENDIX I: Preclinical Retroviral hs-tk Studies 21 
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