MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Stuay 
NJIH 2514-2, Minor Patient's Assent to Participate :r. A Clinicai Research Study 
PDY NUMBER CONTINUATION: page %f $ages. 
the vector-producer cells should not survive and the insertion of the vector should not result in 
new cancerous cells. Indeed, the potential risk of causing a new cancer seems very small 
because no cancers have been found in any of the experiments in which genes have been 
transferred into monkeys (since 1985) and humans (since 1989) using our vectors and 
conditions. 
Third, the result of injecting vector-producer cells into the spinal fluid system may cause 
inflammation of the membranes covering the brain and spinal cord (meningitis) or impair normal 
circulation of the spinal fluid throughout the brain and spinal cord (hydrocephalus). Neither of 
these potential complications occurred in our animal experiments. Meningitis can be treated 
with medications. Treating hydrocephalus might require additional surgery to convert your 
Ommaya reservoir into a shunt, or device which would divert the spinal fluid into the abdominal 
cavity. 
Additional Risks: 
Finally, because this procedure is relatively new, it is possible that despite our extensive 
efforts, other unforeseen problems may occur including the possibility of death. 
Risks of Cytovene Therapy: 
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 platelet count drop significantly. Discontinuation of the drug results in 
normalization of the white blood cell and platelet numbers. Cytovene may cause permanent or 
temporary infertility and may be associated with birth defects. Therefore, women of childbearing 
age should use effective contraception during Cytovene therapy and men should use 
contraception during and for at least 90 days following Cytovene therapy. Pregnant women are 
; not eligible for this protocol. Cytovene can cause cancer in animals. There is no information 
available to estimate the risk of this in humans. 
DURABLE POWER OF ATTORNEY 
You have an illness that at some point may impair your ability to think clearly and to make 
decisions. A Durable Power of Attorney is a process by which you appoint someone to make 
decisions about your medical care at the Clinical Center should you become, and only if you 
become, unable to make these decisions yourself. Such people might include a husband, wife, 
other family member or close friend. It is important that this person know your moral, religious 
CONTINUATION SHEET for either 
NIH-251 4-1 (10-84) 
GPO 9H-329 
Recombinant DNA Research, Volume 18 
NIH-2514-2 (10-84) 
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