in my chest. The tumor(s) that has been removed will be used to make a vaccine. 
In addition, a small piece of tissue will be saved for examination by a 
pathologist . 
The vaccine will also consist of fibroblasts. These are cells that normally 
reside in the skin. In order to obtain these cells, a small piece of my skin 
(1/2 inch wide and 2 inches long) will be removed either subsequently at the same 
time that my tumor(s) was excised. When enough of these cells have been obtained 
we will take a mouse virus, put into this virus a cancer- fighting human gene, and 
then insert the virus into your fibroblast cells. The virus, which is used 
strictly as a "transportation system," will also contain a bacterial gene which 
serves as a marker so we can locate the cancer- fighting gene. This new gene will 
enable your fibroblast skin cells to make a normal human protein called 
interleukin-4, which is usually made in very small amounts only by cells of my 
immune system. Interleukin-4 is thought to stimulate an immune response to the 
tumor cells in the vaccine. This immune response may make my tumors shrink. 
The tumor cells and the fibroblasts that are making interleukin-4 will be 
injected into my skin using a very small needle at 5 places on the left side of 
my lower back. Approximately three to four weeks after the skin biopsy has been 
obtained. These sites will be marked with permanent india ink so that their 
location will be known. Each site will contain different amounts of cells making 
different doses of interleukin-4. One vaccination will not make any interleukin- 
4 at all. I must return to the clinic daily for 5 days after these injections 
for the purpose of evaluating me for any side effects. 
Two weeks after vaccination, all five injection sites will be biopsied under 
local anesthesia using a 6mm skin punch biopsy knife. These biopsies will 
require 1 or 2 skin stitches each. The pieces of skin that are removed will be 
examined for evidence that the vaccine is working. 
At the same time, I will be revaccinated with 5 injections into the skin using 
the highest dose of interleukin-4 that did not cause problems with my skin, such 
as ulceration or infection. As I did after the first set of injections, I will 
visit the clinic every day for the first 5 days for evaluation. One, 2, 4, 7, 
and 14 days after revaccination, a skin biopsy will be performed again to 
evaluate the reaction to each vaccine. As before, these skin biopsies will be 
done under local anethesia and will need 1 or 2 skin stitches. 
Lastly, I understand that I must return to the clinic one and two months after 
the second vaccination to evaluate my progress. 
RISKS AND BENEFITS: 
The potential benefit of this treatment lies in the possibility that my tumor 
will shrink or disappear. If this happens, I may or may not live longer. 
Symptoms caused by my tumors may get better after therapy. 
There is a small risk associated with skin biopsy that includes infection and 
bleeding. Both of these complications are easily treated. There is also risk 
associated with lung biopsy performed under general anesthesia through a 
Patient's Signat-nrp 
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Recombinant DNA Research, Volume 16 
