MEDICAL 
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 
pages. 
j 
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I 
Risks of the TK Gene Transfer Even though the disabled mouse viral vectors cannot grow and 
are considered harmless in humans, it is possible that events could occur within the cells that would 
permit the virus to grow and/or make the cells cancerous. Gene transfer using disabled mouse 
viruses has been used in adult and child patients with cancer. None of the more than 15 humans . 
that have received genes transferred by vectors into their cells, and followed since these 
experiments started in 1989, has developed any problems related to the gene transfer method. We 
believe these vectors are safe and are not a threat to other people or to society. 
This is the first experiment in humans that will involve the implantation of the mouse producer 
cells into the body. This method of treatment has 3 major potential problems. First, the TK gene 
may be passed into surrounding normal tissue in addition to tumor tissue. We have not found any 
evidence of problems in mice and rats due to the spread of vector to surrounding normal brain 
tissue or to other sites in the body. We believe that some of the surrounding blood vessel cells 
probably do have the TK vector, but the number is too small to result in significant adverse side 
effects. It is possible that bleeding and neurologic symptoms (headache, convulsions, stroke) may 
I 
develop with Cytovene®. Second, the mouse cells might persist in your body and cause cancer or 
f. 
other diseases. We expect your immune system to reject (kill) the mouse cells in 1-2 weeks. Thus, 
they should not be able to survive and grow in your body. In addition, we expect the Cytovene® j 
therapy will kill all cells with the TK vector, including the mouse producer cells. Therefore, the 
mouse cells should not survive and the insertion of the vector should not result in new cancerous 
cells, since we think all of the cells with the TK gene will be killed by Cytovene®. In addition, we 
have not been able to induce cancers with these vectors in animals and have seen no cancers in 
any of the humans treated with gene therapy. (Monkeys have been followed since 1985 and 
- 
humans have been followed since 1989). Therefore, we feel that the risk of developing a new 
cancer is very small. A third potential problem is that because this procedure is relatively new, it is 
possible that despite our extensive efforts, other unforeseen problems may occur including the 
PATIENT 
IDENTIFICATION 
CONTINUATION 
SHEET for either 
[828] 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 15 
