TABLE OF CONTENTS 
1 . 0 Introduction 3 
2.0 Objectives 14 
3.0 Selection of Patients 17 
4.0 Clinical Evaluation Prior to Treatment 19 
5.0 Stratification and Randomization 20 
6.0 Nature of Procedures or Therapeutic Agents ...21 
7.0 Dose of Therapeutic Modifications 2 6 
8.0 Study Parameters 27 
9.0 Off-Study Criteria 28 
10.0 Evaluation of Results 3 3 
11.0 Schema/Duration 34 
12.0 References 37 
13.0 Preliminary Data 42 
14.0 Common Toxicity Criteria 60 
15.0 Informed Consent 61 
16.0 Scientific Abstract 62 
17.0 Non-technical Abstract 63 
18.0 Appendix I - IRB Approval and Application ....64 
19.0 Appendix II - Curriculum Vitae 65 
20.0 Appendix III - Background Papers 66 
21.0 Appendix IV - Supplemental Figures 67 
22.0 Points to Consider 68 
23.0 Appendix V - Nucleotide Sequences 
of Proposed Plasmids 92 
24.0 Appendix VI - Description of Revisions for 
the 11/21/91 HGT Subcommittee Meeting 109 
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Recombinant DNA Research, Volume 15 
