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 
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Research Study 
STUDY NUMBER CONTINUATION: 
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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 
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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 
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develop with Cytovene®. Second, the mouse cells might persist in your body and cause cancer or 
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® 
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 
possibility of death. 
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Cytovene® Therapy 
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Cytovene® has been used extensively in humans to treat a number of infections including 
viral infections of the eye. We will be following the recommended dose for therapy that has been 
used to treat viral infections of the eye. The most commonly observed complication in people 
receiving Cytovene® has been the development of decreased white blood cell and platelet counts. 
This could result in an increased risk of infection and bleeding. We will monitor these counts every 
other day (during Cytovene treatment) and the drug will be discontinued if the white blood count or 
PATIENT 
'IDENTIFICATION 
CONTINUATION SHEET for either 
I 
[844] 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 15 
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