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 lymphocytes 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 l}anphocytes 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 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 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, including skin, muscle 
and blood if available on days 1-2-3-7-14-21-28 and then monthly as possible. 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 at monthly intervals thereafter. 
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 concerning you and your treatment will appear 
publicly without your consent. 
Follow-Up 
After you recseive each cycle of therapy you will be discharged from the 
hospital. At six to eight weeks after the last treatment you will be required 
to return to the University of Pittsburgh for follow-up studies. Tests used to 
decide if your tumor has responded to the therapy will be similar to those you 
had before beginning the therapy. 
If your disease recurs after treatment in this protocol, you will be 
eligible to be considered for other protocols at the National Cancer Institute 
and you will receive treatment as indicated by your disease or referred elsewhere 
for sue treatment. As this is a new therapy, side effects that may cause your 
condition to deteriorate may be encountered. You will be watched closely for any 
side effects. 
You are free to withdraw your consent to participate in this study at the 
University of Pittsburgh and seek care from any physician at any time. 
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Recombinant DNA Research, Volume 14 
