May 28, 1992 
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-4 (IL-4) gene will be introduced into a fibroblast line established from the 
patient. These gene-modified fibroblasts mixed with autologous tumor cells will then be 
injected into the back 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-4 secreted by the gene modified fibroblasts. To further 
evaluate the immune system of the patient to fight their tumor, stimulated lymphocytes will 
be cultured from the injected tumor itself. These lymphocytes will be expanded in vitro 
and studied in a number of ways. Animal models have shown that the injection of gene 
modified tumor cells has important antitumor effects. A second series of injections will be 
carried out two weeks later. Multiple biopsies of injected sites will be obtained after each 
immunization. 
The patients will be evaluated for antitumor effects engendered by the injection of 
the gene modified fibroblasts mixed with tumor cells themselves. The injection of gene 
modified fibroblasts mixed with 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 active 
immunotherapy as well as expand the use of subsequent administration of IL-2 to patients 
with other malignancies not currently amenable to immunotherapy. 
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Recombinant DNA Research, Volume 16 
