TABLE OF CONTENTS 
1.0 Introduction 3 
2.0 Objectives 16 
3.0 Selection of Patients 19 
4.0 Clinical Evaluation Prior to Treatment 21 
5.0 Stratification and Randomization 2 2 
6.0 Nature of Procedures or Therapeutic Agents 2 3 
7.0 Schema/ Duration 28 
8.0 Dose of Therapeutic Modifications 2 9 
9.0 Study Parameters 3 0 
10.0 Off -Study Criteria 3 5 
11.0 Evaluation of Results 3 6 
12.0 References 39 
13.0 Preliminary Data 4 3 
14.0 Common Toxicity Criteria 49 
15.0 Informed Consent 51 
16.0 Scientific Abstract 51b 
17.0 Non-technical Abstract 53 
18.0 Appendix I - IRB Approval 54 
19.0 Appendix II - Curriculum Vitae 55 
20.0 Appendix III - Background Papers 56 
21.0 Appendix IV - Response to Points to Consider .... 58 
22.0 Appendix V - Nucleotide Sequences 
of Proposed Plasmids 78 
Recombinant DNA Research, Volume 17 
[691] 
