MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 25 : , Consent :o Participate in A C'.imcai Research Stuay 
NIH 25 '--2, Minor Parent's Assent to 3 art;c;cate r A Cimcal 
JDY NUMBER CONTINUATION: page 2 of ^bages. 
Research Stuay 
is produced by “vector-producer” cells (little factories that produce the cars containing the 
passengers). When the vector/gene combination gets into your tumor cells it inserts itself into the 
cells’ genetic material (chromosomes) and tells the tumor cells to begin making thymidine kinase 
(and thus behave like a herpes virus). We will also attach to the vector vehicle a bacterial gene 
which we think is harmless; this gene serves to mark the location of the TK gene in your body. 
When we give you Cytovene, the tumor cells containing the TK gene make harmful substances 
within themselves that cause the tumor cells to die. We do not expect normal spinal cord or brain 
1 cells to be injured because the vector/gene combination is attracted only to rapidly growing cells. 
Normal cells in the brain and spinal cord are not rapidly growing, but tumor cells are and 
therefore become targets for the vector/gene combination. 
PRETREATMENT EVALUATION 
You will be admitted to the hospital for approximately 1-2 weeks for the pretreatment 
evaluation and the various procedures. You will have a complete neurological and physical 
; examination, blood, and urine tests to determine your overall physical health. The amount of 
blood drawn from you will be no more than three ounces in one day and will not exceed one pint 
over your stay at the hospital. You may experience some discomfort or temporary pain at the site 
of the needle entry for the routine blood studies. There is remote risk of fainting and local 
5 infection. In addition a spinal tap will be done for initial spinal fluid tests. You may experience 
some discomfort or temporary pain at the site of the needle entry for the spinal tap or headaches 
immediately after the procedure. There is a remote risk of local infection or meningitis 
(inflammation of the coverings of the brain or spinal cord). 
You will also have x-rays of your chest and head and any other areas of the body as 
indicated by your medical examination and history. An electrocardiogram will be performed. 
Additional tests may be required depending upon your state of health and prior therapies. The 
blood tests will also include a test for the HIV (AIDS) virus. Women of childbearing age will also 
have a pregnancy test. Patients who are HIV positive and pregnant women will not be eligible 
for this protocol. We do not know the impact of experimental drugs on fetal development. 
Damage to cell growth may occur while you are being administered the drugs or after 
administration of drugs. Therefore, only those individuals who are using effective means of 
contraception will be permitted in this study. 
An MRI scan of your brain and spinal cord will be done. MRI is designed to examine the 
changes in the nervous system that occur with tumor seeding of the lining of the brain and spinal 
cord. MRI is a new diagnostic tool that uses a strong magnetic field and radio waves to show 
structural and chemical changes in the brain and spinal cord tissues. This technique has been 
found more sensitive than x-rays to detect a variety of processes within the brain and spinal cord. 
In addition, MRI has the advantage of not using radiation. Dunng the MRI study, a needle will be 
placed into a vein in your arm and an image-enhancing dye, gadolinium, will be administered 
= A'E\7 3E\" CA'ON 
CONTINUATION SHEET for either 
NIH-25U-1 ( “1 0-8*1) 
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Recombinant DNA Research, Volume 18 
NIH-2514-2 (10-84) 
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