Medical Record . Continuation Sheet for Consent to Participate in a Clinical Research Study 
Number ..Continuation: page 2 of 8 pages 
found in mice - that has been inactivated so that it can not cause disease. We call this vehicle a 
“vector”. We insert the TK gene (the passenger) into the vector and the vector carries the gene into 
your brain tumor cells. The vector/gene combination 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. We will also attach to the vector vehicle a bacterial gene that 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 produce harmful substances within themselves 
that cause the tumor cells to die. We do not expect normal brain cells to be injured because the 
vector/gene combination is attracted only to rapidly growing cells. Normal cells are not rapidly 
growing but tumor cells are and are therefore targets for the vector/gene combination. 
Pretreatment Evaluation: 
You may be admitted to the hospital for approximately 1 week for the pretreatment evaluation 
and the following 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 infection. 
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 with HIV and pregnant women will not be eligible for this protocol. 
An MRI scan and/or a CT scan of your brain will be done. Both scans are designed to 
examine the changes in the nervous system that occur with the recurrence of the brain tumor . MRI 
uses a strong magnetic field and radio waves to show structural and chemical changes in the brain 
tissues. A CT scan uses x-rays. The type of scan chosen will depend upon the status of your tumor 
and the response to this therapy. During the scan, a needle will be placed into a vein in your arm and 
an image-enhancing dye may be administered through that vein before obtaining a second set ot scans. 
Each scan takes about 60 to 90 minutes. Scans will be repeated periodically after injection of the 
vector producing cells to monitor the effects of this therapy on tumor growth. 
TREATMENT PHASE 
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