INITIAL PROPOSAL OF CLINICAL RESEARCH PROJECT 
Date:_ Clinical Project Number: 
To: Chairman, Clinical Research Subpanel, NCI 
Recommended by: _, Deputy Clinical Director, 
Title: 
' j I 
A \,^v — Branch Chief 
s) 
IMMUNIZATION OF CANCER PATIENTS USING AUTOLOGOUS CANCER CELLS 
NCI 
MODIFIED BY INSERTION OF THE GENE FOR INTERLEUKIN-2 
Identifying Words: gene therapy, immunotherapy, interleukin-2, tumor infil- 
trating lymphocytes 
,JQ 
Principal Investigator: Steven A. Rosenberg, M.D., Ph.D. ' 
Associate Investigators: W.F. Anderson, M.D., Molecular Hematology Branch, NHLBI 
M.R. Blaese, Cellular Immunology Section, MB, NCI 
S.E. Ettinghausen, M.D., Surgery Branch, NCI 
P. Hwu, M.D., Surgery Branch, NCI PH-' 
S.E. Karp, M.D., Surgery Branch, NCI /a 
A. Kasid, Ph.D., Surgery Branch, NCI 0^ 
J. J. 
D.R. 
J.C. 
D. J. 
S.L. 
J.S. 
J.R. 
J.C. 
W.M. 
Estimated Duration of Study: 
Number and Kind of Subjects Needed: 
Mule, Ph.D., Surgery Branch, NCI 
Parkinson, M.D., Cancer Therapy^-Hyaluation Progr 
Salo, M.D., Surgery Branch, NC±V >;5J /' 
Schwartzentruber , M.D., Surgery /Branch, NCI < r^y \ 
Topalian, M.D., Surgery Branch, NClZTd I 
Weber, M.D., Surgery Branch, NCI 
Yannelli, Ph.D., Surgery Branch, 
Yang, M.D., Surgery Branch, NCI \Y,Cr 
Linehan, M.D. , Surgery Branch, NClJ 
3 years 
Number 
Sex 
(M or F) 
Age 
Patients 
50 
M&F 
18 & older 
Precis: When tumor is resected from patients as part of the natural course of their 
treatment, an attempt will be made to establish a tissue culture line of the tumor. 
The gene coding for interleukin-2 will be introduced into these tumor cells and the 
integration and expression of this gene will be tested. Patients will become eligible 
for this study only if they develop metastatic cancer that has failed all standard 
effective treatment and have no other effective treatment options available to them. 
Tumor cells will be injected intradermally and subcutaneously into the thigh of these 
patients. The amount of tumor injected will be less than l/50th the total tumor burder 
of that patient. In previous studies we have shown that these gene modified tumor cells 
are more immunogenic than the native unaltered tumor. Attempts will then be made to 
grow immune lymphocytes either from the tumor site or from the draining lymph nodes of 
Recombinant DNA Research, Volume 15 
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