has four pins which anchor it to your skull and keep it from moving during subsequent 
procedures. The pin sites will be anesthetized so there will be no pain. After the tumor has 
been located by CT and/or MRI scanning you will be taken to the operating room. The 
procedure of injecting the virus is similar to that of doing a tumor biopsy. Local or general 
anesthesia can be used. Your doctor will discuss the advantages and the risks of both types 
of anesthesia to help you make a choice of which you prefer. A one inch long incision will be 
made in your scalp and a small hole will be opened in your skull to expose your brain above 
the tumor. A thin needle will be inserted through the hole into the tumor and virus injected 
into the tumor. Then the needle will be removed, the hole plugged and your scalp wound 
sutured closed. Following surgery, you will be monitored in the intensive care unit (ICU). 
During the various stages of therapy, you will receive various drugs to prevent convulsions 
and swelling within the brain. These drugs are used routinely in neurosurgery and are given 
to almost all patients who undergo brain tumor surgery. Antibiotics will be given to you on 
the day of surgery. 
One day after the injection of the virus, you will start the Cytovene® treatment and 
continue treatment for 14 days. Cytovene® will be given to you by intravenous infusion two 
times a day over about an hour. You may have an MRI or CT scans before, during and after 
Cytovene® therapy. You may be kept in a quarantine room during part of your 
hospitalization after virus injection. This may limit or inhibit visits by your family and other 
visitors. 
Follow-up Care and Evaluation: 
After you finish the course of Cytovene® you will be discharged from the hospital. Two 
weeks after discharge, you will be required to return as an outpatient for follow-up studies. 
You will undergo neurological and physical examinations and laboratory tests, as were 
performed before your surgery. The memory and comprehension tests will be repeated to 
determine whether the treatment has had subtle effects on parts of your brain not 
associated with the tumor. A family member or care-taker will also be asked to fill out a 
questionnaire regarding your status after the treatment. An MRI or CT scan of the brain may 
also be obtained. Following the initial visit, you will be seen as an outpatient at 2 week 
intervals for 2 months and monthly for 10 months. The number of visits after the first year 
will depend on the status of your tumor. We expect that we will obtain one sample of blood 
per year of no more than 18 teaspoons (3 ounces) for the remainder of your life to monitor 
the safety of this gene transfer methodology. 
III. RISK ASSOCIATED WITH EVALUATION AND TREATMENT 
Risk of MRI and CT Scans: 
MRI and CT brain scans are painless procedures that are very safe for most patients. 
You probably had one or more during your first treatment of your brain tumor or before you 
joined this study. During the scan you will lie in a long metal cylinder, which people who fear 
closed spaces sometimes find a little frightening. Patients can be observed at all times by 
the operators and can be assisted if necessary. You will be moved out of the machine if 
requested. The MRI machine makes a thumping sound while operating. 
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