Protocol ID93-008 
Revised April 12, 1994 
THE UNIVERSITY OF TEXAS 
M. D. ATHDERSON CANCER CENTER 
DEPARTMENT OF GYNECOLOGIC ONCOLOGY 
Protocol: Use of a retroviral vector to study the trafficking 
patterns of purified ovarian tumor infiltrating 
lymphocytes (TIL) used in intraperitoneal adoptive 
immunotherapy of ovarian cancer patients. A pilot 
study 
Page 
1.0 OBJECTIVES 1 
2.0 BACKGROUND AND RATIONALE 1 
3.0 BACKGROUND DRUG INFORMATION 6 
4.0 PATIENT ELIGIBILITY 9 
5.0 RESEARCH PLAN 11 
6.0 PATIENT EVALUATION 13 
7.0 EVALUATION AND MANAGEMENT OF TOXICITY 13 
8.0 CRITERIA FOR RESPONSE 13 
9.0 CRITERIA FOR REMOVAL FROM STUDY 14 
10.0 STATISTICAL CONSIDERATIONS 14 
1 1 .0 POTENTIAL SIDE EFFECTS AND REPORTING OF :. 15 
ADVERSE REACTIONS 
REFERENCES 17 
APPENDIX I PCR Quantitation & neo labeling of 
rIL-2 expanded TIL-derived T cells 
APPENDIX II Informed Consent 
PROTOCOL CHAIRMAN: 
CO-CHAIRMEN: 
Ralph lS.jFreedmaiC^.D., Ph.D. Date 
Department of Gynecologic Oncology 
^ ////o/9 i’ 
IS. Ph.D* Datef 
Chris D. Platsoucas, Ph.D.* 
Department of^dicrot^iology ^ Immunology . 
Albert B. Deisseroth 
Department/of Hematology 
Date 
The Division of Surgery, Department of Gynecologic Oncology. The University of 
Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard. Houston, TX 
77030 
*Room 525§-MS, Temple University School of Medicine. 3400 N. Broad St., 
Philadelphia. PA 19140 
Recombinant DNA Research, Volume 19 
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