;1EDICAL 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; 
lymphocytes will be isolated from your tumor as usual. 
CONTINUATION: page_4_of _Z pages. 
A portion of these lymphocytes 
will have the gene Inserted. The gene is attached to a harmless virus that can enter your 
lymphocytes, taking the gene with it. These "marked" lymphocytes are then grown in the 
laboratory in large numbers. Special tests are performed on these marked lymphocytes 
to determine if they are growing properly with no abnormalities so as to minimize the 
foreseeable risks to you (see below). If no abnormalities in the marked cells are 
identified, they will be given back to you through your vein along with the other 
unmarked lymphocytes at the appropriate time. 
There are some potential risks to this procedure. First, even though the 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 allows the virus to grow or 
cause the cell to become cancerous. To minimize this possibility, the gene-marked lympho- 
cytes will be tested and if any abnormalities are found, they will be discarded. However, 
since this is a new procedure, we do not know whether or not the marked cells could 
become abnormal after they have been injected. In a number of animal experiments, we 
have been unable to demonstrate either virus production or the development of cancer 
cells for greater than two years after treatment. There is a'remote possibility, however, 
that the altered tumor infiltrating lymphocytes that we administer could cause a tumor. 
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 antibiotic 
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 only been 
used^ before in 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 that death may occur. 
■You will undergo biopsy of tumor and other tissue, if available, on several occasions 
before and after the TIL are given. Blood and tissue specimens will be taken where 
possible to follow the life span and function of these marked cells. 
This clinical procedure has attracted a great deal of attention from the lay media. We 
will make every effort to protect the confidentiality of you and your family. However, 
because of this media interest there is a greater risk than usual that information con- 
cerning you and your treatment will appear publicly without your consent. 
Follow-Up 
After you receive each cycle of therapy you will be discharged from the hospital. At 
eight weeks after the last treatment you will be required to return to the NIH for 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2514-1 (10-S4) 
NIH.2514-2 (10-84) 
P A ; 09-25-0099 
Recombinant DNA Research, Volume 14 
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