APPENDIX C 
ABSTRACT OF PROTOCOL 
This protocol is a study of patients with advanced cancer who have failed 
standard therapy. In an attempt to increase the patient's immune response to the 
tumor, the interleukin-2 (IL-2) gene will be introduced into a tumor cell line established 
from the patient. These gene-modified autologous tumor cells will then.be injected 
into the thigh of the patient. This injection will augment the immune responses of the 
patient because a subcutaneous location will be utilized as well as the immune 
stimulatory effects of the IL-2 secreted by the gene modified tumor cells. To further 
utilize the immune system of the patient to fight their tumor, stimulated lymphocytes 
will be cultured from either the draining lymph nodes or the injected tumor itself. 
These lymphocytes will be expanded in vitro and given intravenously to the patient 
along with IL-2 in a manner similar to current tumor infiltrating lymphocyte clinical 
protocols. Animal models have shown both the injection of gene modified tumor cells 
and the derived stimulated lymphocytes to have important antitumor effects. 
The patients will be evaluated for antitumor effects engendered by the injection 
of the gene modified tumor cells themselves as well as after the infusion of the 
cultured lymphocytes. The injection of gene modified tumor cells may serve to 
"immunize" the patient to their tumor and may be amenable to use in a wide variety 
of tumor types, especially those that are poorly immunogenic. This protocol may also 
increase the effectiveness of adoptive immunotherapy as well as expand the use of 
cultured lymphocytes to other malignancies not currently amenable to TIL therapy. 
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