PROCEDURES TO BE UNDERTAKEN 
Before receiving any treatments, I will have a number of tests to determine if I qualify for the 
study. These studies may include the following: 1) x-rays of the brain, chest and abdomen; 2) blood 
tests; 3) testing your blood for the antibodies to human immunodeficiency virus (HIV) that causes AIDS. 
If I am found to have these antibodies, I may not participate in this study. If I do qualify, I will undergo a 
series of procedures as part of the treatment. 
I understand that the first step will require the surgical removal of one of my metastatic tumors in 
order to grow the tumor cells in a test tube. This surgical procedure will probably be done under local 
anesthesia but may require general anesthesia. My tumor cells will then be modified by insertion of 
genetic material using a mouse virus which will result in their production of IL-4, a protein normally made 
by the body's immune system which can help stimulate immune cells. 
After making these modified tumor cells, they will be irradiated in the test tube and then injected 
into the skin of my thigh or underarm area in order to stimulate an immune reaction in nearby lymph nodes 
against my tumor. The injections will be done with a standard needle and syringe. Approximately 7 to 10 
days later, the lymph nodes adjacent to the injected skin sites will be surgically removed. This procedure 
will probably be done under local anesthesia. The lymph nodes will be taken to the laboratory where the 
cells from them will be further stimulated in the test tube and grown into larger amounts. After 2 to 3 
weeks, the lymph node cells should have grown sufficiently enough to transfuse them back into me along 
with the administration of IL-2. This part of the treatment will require hospitalization for several days. I 
am aware that it will be necessary to place an intravenous catheter through a vein either on the upper chest 
or in the neck that will be threaded into a central vein in my body. This intravenous catheter is placed 
under local anesthesia at the bedside. The lymph node cells will be infused once through this intravenous 
catheter over a 30 minute period and will be followed by 15 minute IL-2 infusions given every 8 hours for 
up to 15 doses. The IL-2 is a protein normally produced by the body which is given to allow the injected 
lymph node cells to remain alive. 
I understand that at different times in the study, biopsies of superficial tumors or the skin injection 
sites may be performed. These biopsies would be performed under local anesthesia and would not occur 
more than two times. 
RISKS AND SIDE EFFECTS 
I know that there are potential side effects and risks to these procedures which are summarized 
below. 
Surgical removal of tumor and lvmph nodes: 
These procedures may be associated with discomfort which should be minimized by an appropriate 
anesthetic agent. It is possible I may develop bleeding or an infection at the site of the procedure, I will 
receive a separate surgical consent document for these procedures. 
Skin injection with gene-modified tumor cells: 
I will be injected with gene-modified tumor cells into the skin in an attempt to stimulate an immune 
response against my tumor. This may cause mild discomfort at the site of injection. One possible side 
effect may be growth of tumor at the skin injection site. The tumor cells will have been irradiated prior to 
the injection procedure in an effort to avoid this problem. If tumor does grow at the injection sites, they 
will be removed surgically in order to minimize problems in these areas. 
I understand the potential risks associated with receiving cells modified by this gene. The genetic 
material was inserted into my tumor cells with the use of a mouse virus. I have been informed that even 
though the mouse virus used to insert the gene into my tumor cells cannot grow and is considered 
harmless to me, it is possible that events could occur within the cell that allow the virus to grow. To 
minimize this possibility, the virus used to modify the cells will be tested extensively prior to use. I am 
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