THE UNIVERSITY OF TEXAS PfOtOCOl 
M.D. ANDERSON CANCER CENTER 
Division of Medicine 
Protocol Title: Use of safety-modified retroviruses to 
introduce chemotherapy resistance sequences 
into normal hematopoietic cells for 
chemoprotection during the therapy of breast 
cancer: A Pilot Trial 
1.0 OBJECTIVES 
2 . 0 BACKGROUND 
3.0 BACKGROUND DRUG INFORMATION 
4.0 PATIENT ELIGIBILITY 
5 . 0 TREATMENT PLAN 
6 . 0 PRE-TREATMENT EVALUATION 
7.0 EVALUATION DURING STUDY 
8.0 CRITERIA FOR RESPONSE AND TOXICITY 
9.0 CRITERIA FOR REMOVAL FROM STUDY 
10.0 STATISTICAL CONSIDERATIONS 
REFERENCES 
APPENDIX Al: 
APPENDIX A2: 
APPENDIX B: 
APPENDIX C: 
APPENDIX D: 
APPENDIX E: 
APPENDIX F: 
APPENDIX G: 
APPENDIX H: 
APPENDIX I: 
CONSENT FORM 
Study Chairman : 
Albert B. Deisseroth, M.D., Ph.D. 
Study Co-Chairman : 
Richard Champlin, M.D. 
Gabriel Hortobagyi, M.D. 
[519] 
Zubrod Performance Scale 
Cardiac Status Scale 
Ceprate Stem Cell Collector 
Manuscripts on MDR-1 Transduction 
Preparation and Conditions of Exposure of 
Retrovirus 
NCI Common Toxicity Criteria 
Evaluation Before and During Therapy 
Immunohistochemistry for breast cancer 
Background Dirug Information 
Statistical Analysis of Trial Results 
Recombinant DNA Research, Volume 19 
