;DICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 
CONTINUATION: page JL of M: pages . 1 
thigh, either in the skin or just below the skin. About three weeks later we 
will remove the lymph nodes that drain the tumor-bearing area and use them to 
grow immune cells called lymphocytes which will later be given back to you as 
part of your immunotherapy. We will carefully observe the site of the tumor 
injection. If the tumor grows, we will remove it, attempt to grow immune 
lymphocytes from it, and if successful, use them in your treatment. If no 
tumor grows, the site will be surgically excised at about eight weeks after 
the injection. If we return lymphocytes to you for your treatment, you will 
also receive interleukin-2 (IL-2), a protein normally made by the body's 
immune system that can help the immune cells destroy your tumor. We cannot 
predict whether this approach will be of benefit to you in any way. It is a 
highly experimental technique. We are attempting to learn if it is of benefit 
in the treatment of patients with cancer. 
Procedures 
Before receiving any drug therapy you will have a number tests to make 
sure you qualify for the study. The tests will be done on an in-patient or 
out-patient basis and 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) the virus that causes AIDS. If you are 
found to have these antibodies, you may not participate in this study. If you 
do qualify, you will undergo a series of procedures as part of the treatment. 
The first step will be the injection of the gene-modified tissue-cultured 
tumor into three sites in your thigh. This tumor will be injected either into 
the skin or underneath the skin at three separate sites. The injectipns will 
be done with a standard needle and syringe and will be marked with tattooed 
dots. We will observe these sites carefully and have them inspected at least 
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Recombinant DNA Research, Volume 15 
HIH- 2514*1 (1044) 
