Table of Contents 
1-.0 Introduction 1 
2.0 Study Objectives 4 
3 . 0 Eligibility Criteria 4 
4.0 Registradon 4 
5.0 Pre-Study Evaluation Requirements 6 
6.0 T reatment Plan 6 
7.0 Study Evaluations 8 
8.0 Potential Toxicity, Dose Modifications, and Management 13 
9.0 Adverse Drug Reaction (ADR) Reports 14 
10.0 Drug Preparation, Formulation, and Availability 15 
1 1 .0 Response Criteria 15 
12.0 Removal from Study 16 
13.0 Concomitant or Ancillary Therapy 16 
14.0 Statistical Considerations 17 
15.0 References 18 
Appendices: 
Patient Informed Consent 
Appendix A - Evaluation of Performance Status (Kamofsky Scale) 
Appendix B - Required Study Evaluations 
Appendix C - Toxicity Grading Criteria 
Appendix D - Pharmacokinetics 
Appendix E - Pharmaceutical Data 
Appendix F - Procedure for Determination of p53 Tumor Suppressor Gene Alteration 
Appendix G - Assay Methodologies 
Recombinant DNA Research, Volume 20 
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