TABLE OF CONTENTS 
1.0 Introduction 3 
2.0 Objectives 7 
3.0 Selection of Patients 9 
4.0 Clinical Evaluation Prior to Treatment 11 
5.0 Stratification and Randomization 12 
6.0 Nature of Procedures or Therapeutic Agents 13 
7.0 Schema/Duration 17 
8.0 Dose of Therapeutic Modifications 18 
9 . 0 Study Parameters 19 
10.0 Off-Study Criteria 24 
11.0 Evaluation of Results 25 
12.0 References 27 
13.0 Preliminary Data 29 
14.0 Common Toxicity Criteria 39 
15.0 Informed Consent 40 
16.0 Scientific Abstract 41 
17.0 Non-technical Abstract 42 
18.0 Appendix I - IRB Approval 43 
19.0 Appendix II - Curriculum Vitae 44 
20.0 Appendix III - Background Papers 45 
21.0 Appendix IV - Methods 4 6 
22.0 Response to Points to Consider 52 
23.0 Appendix V - Nucleotide Sequences 
of Proposed Plasmids 72 
Recombinant DNA Research, Volume 18 
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