INITIAL PROPOSAL OF CLINICAL RESEARCH PROsJECT 
Date: Clinical Project Number: 
To: Chairman, Clinical Research Subpanel, NCI 
Recommended by: , Deputy Clinical Director, NCI 
Branch Chief(s) 
Title: Gene therapy of patients with advanced cancer using tumor infiltrating 
lymphocytes transduced with the gene coding for tumor necrosis factor 
Identifying Words: gene therapy, immunotherapy, interleukin-2, tumor infiltrating 
lymphocytes, tumor necrosis factor, cancer 
Principal Investigator: Steven A. Rosenberg, M.D. , Ph.D. 
Medically Responsible Investigator: Steven A. Rosenberg, M.D. , Ph.D. 
Associate Investigators: A. Kasid, Ph.D., Surgery Branch, NCI 
W. F. Anderson, M.D. , Laboratory of Molecular Hematology, NT 
R. M. Blaese, M.D., Cellular Immunology Section, MB, NCI 
P. Aebersold, Ph.D., Surgery Branch, NCI 
J. Yang, M.D., Surgery Branch, NCI 
S. Topalian, M.D. , Surgery Branch, NCI 
Major Collaborators: M. Kriegler, Ph.D., Cetus Corporation, Emeryville, CA 
B. Maiorella, Ph.D., Cetus Corporation, Emeryville, CA 
R. Moen, M.D., Ph.D., Genetic Therapy, Inc., Rockville, MD 
Y. Chiang, Ph.D., Genetic Therapy, Inc., Rockville, MD 
Estimated Duration of Study: 3 years 
Number and Kind of Subjects Needed: Number Sex Age 
(M or F) 
Patients 50 M&F 16 and Older 
Precis: Patients with advanced cancer who have failed all effective therapy will 
be treated with escalating doses of autologous tumor infiltrating lymphocytes 
(TIL) transduced with the gene coding for tumor necrosis factor. Escalating 
numbers of transduced TIL will be administered at three weekly intervals along 
with the administration of interleukin-2. When the maximum tolerated dose of 
transduced TIL is established then the cell dose will be dropped 10-fold and 
selected transduced TIL will then be administered in a similar escalating dose 
schedule. 
Recombinant DNA Research, Volume 14 
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