EDICAL 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: pagel__ of pages. 
large numbers. Special tests are performed on these cells to determine that 
they contain the new genes and that IL-2 is being produced. 
There are some potential risks to this procedure. First, even though the 
mouse virus used to insert the gene into your lymphocytes cannot grow and is 
considered harmless to you, it is possible that events could occur within the 
cell that allow the virus to grow. To minimize this possibility, the gene- 
marked tumor cells will be tested and if any virus is found, the cells will be 
discarded. Second, the inserted gene produces a protein that inactivates 
certain antibiotics. These antibiotics are not commonly used to treat 
infections in humans, and many other antibiotics are available that will not 
be inactivated and would be effective in treating bacterial infections. 
We emphasize that this procedure, called retroviral-mediated gene transfer, 
has been used before only in a very few human patients. Because this 
procedure is relatively new, it is possible that despite our extensive 
efforts, other unforeseen problems may occur including the very remote 
possibility of death. 
You will undergo biopsy of tumo r and other tissue, if available, on 
several occasions before and after the tumor infiltrating lymphocytes (TIL) 
from either the tumor or local lymph nodes are given. A maximum of five 
biopsies of lesions in or under the skin may be performed. The biopsies are 
done under local anesthesia and are associated with minor discomfort lasting 
about 24 hours. Blood and tissue specimens will be taken where possible to 
follow the life span and function of the marked cells. 
This clinical procedure has attracted a great deal of attention from the 
Recombinant DNA Research, Volume 15 
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NIH- 2514-1 (1044) 
