APPENDIX A 
Protocol DM 93-012 
REVISED 1/28/93 
THE UNIVERSITY OF TEXAS 
M.D. ANDERSON CANCER CENTER 
Division of Medicine 
Protocol Title: Use of safety-modified retroviruses to 
introduce chemotherapy resistance sequences 
into normal hematopoietic stem cells for 
chemoprotection during the therapy of ovarian 
cancer: A Pilot Trial 
1.0 OBJECTIVES 
2 . 0 BACKGROUND Protocol 
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: 
Zubrod Performance Scale 
Cardiac Status Scale 
Ceprate Stem Cell Collector 
Background Drug Information 
Preparation and Conditions of Exposure of 
Retrovirus 
Toxicity Criteria 
Evaluation Before and During Therapy 
CONSENT FORM 
Study Chairman : 
Albert B. Deisseroth, M.D., Ph. 
Study Co-Chairman : 
John Kavanagh, M.D. 
Richard Champlin, M.D. 
Recombinant DNA Research, Volume 17 
[659] 
