3. 3. 3. 2. y-IFN and HLA expression in Huy vector-transduced 
human melanoma cells 14 
3. 3. 3. 3. Recognition of gene modified melanoma by HLA-restricted, 
melanoma specific, cytotoxic T-cells 14 
3.4 CONCLUSIONS 15 
3.5 LITERATURE CITED 16 
4 . 0 CLINICAL PROTOCOL 46 
4.1 OBJECTIVES 46 
4.2 INTRODUCTION AND BACKGROUND 46 
4.3 PATIENT SELECTION 47 
4.4 PRE-STUDY EVALUATIONS 48 
4.5 REGISTRATION 48 
4.6 STUDY DESIGN 49 
4.7 TREATMENT SCHEDULE AND ON-STUDY EVALUATION 49 
4.8 SCHEDULE FOR TUMOR MEASUREMENTS 49 
4.9 DISCONTINUATION OF THE ACTIVE IMMUNIZATION 
SCHEDULE 50 
4.10 TOXICITY 50 
4.11 PATIENT FOLLOW UP 50 
4. 12 PROCEDURE FOR REPORTING ADVERSE REACTIONS 51 
4. 1 3 STUDY MONITORING 51 
4.14 INFORMED CONSENT 51 
4.15 INSTITUTIONAL REVIEW BOARD 51 
4.16 "ITAT" PREPARATION AND STORAGE 52 
4.17 BIBLIOGRAPHY 53 
5.0 INFORMED CONSENT FORM 55 
6.0 IRB / DBC APPROVAL 60 
7.0 ANSWERS TO RECOMBINANT DNA ADVISORY COMMITTEE 
(RAC) POINTS TO CONSIDER 63 
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Recombinant DNA Research, Volume 17 
