TABLE OF CONTENTS 
Scientific Abstract Page 3 
Non-Tech nical Abstract 4 
IRB/IBC Approval 5 
Response to Recombinant DNA Advisory Committee 7 
(RAC) Points to Consider 
Protocol 
1 .0 Protocol Schema 13 
2.0 Objectives 14 
3.0 Background and Rationale 14 
4.0 Drug Information 21 
5.0 Eligibility Criteria 23 
6.0 Treatment Plan 24 
7.0 Toxicities/Dosage Modifications 27 
8.0 Study Parameters 29 
9.0 Criteria for Evaluation/Removal from Study 30 
10.0 Statistical Considerations 30 
1 1 .0 Ethical and Regulatory Considerations 30 
12.0 Bibliography 32 
Informed Consent Form 35 
Appendices: 
Appendix A: Anti-CD3/IL-2 Activation of LN Cells 40 
Appendix B: Decreased Tumorigenicity of IL-4 Transfected 41 
B16BL6 
Appendix C: Adoptive Immunotherapy of BL6 Pulmonary Metastases with. . . 42 
Activated TDLN Cells from Mice Bearing IL-4 
Appendix D: Vector Scheme, Sequence and Restriction Map 43 
Appendix E: Production of IL-4 by Melanoma Cells after Transduction 44 
Appendix F: Southern Blot Analysis of IL-4 Transduced Cells 45 
Appendix G: Eligibility Checklist 46 
Appendix H: Performance Status 48 
Appendix I : NCI Common Toxicity Criteria 49 
Appendix J: IL-2 Dose Modification 51 
Appendix K: Guidelines for Reporting ADRs 52 
Appendix L: Support Letter from Director, Clinical Research Center 53 
Appendix M: Background Papers 54 
Biographical Sketches 55 
Recombinant DNA Research, Volume 18 
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