Medical Record : Continuation Sheet for Consent to Participate in a Clinical Research Study 
Number ^Continuation: page 3 of 8 pages 
The size and location of your tumor are such that partial surgical removal is possible. 
Therefore you will undergo three procedures in the following order. 1. You will undergo brain 
surgery to remove as much of the tumor as possible with injection of vector-producing cells into areas 
of the remaining tumor. An Ommaya reservoir will be placed under the scalp with a tube connecting 
the reservoir to the tumor site. The reservoir allows for the repeated injection of drugs and cells 
without repeated surgery on the brain. 2. One week after surgery, we will inject additional vector- 
producer cells through the Ommaya reservoir into the tumor cavity. 3. You will receive twice daily 
intravenous injections of Cytovene for 14 days. This portion of the study is expected to require a 3-4 
week hospitalization. 
Surgery: 
You will be taken to the operating room and, following the administration of general 
anesthesia, a craniotomy (direct surgery on the brain) will be performed. A piece of skull will be 
removed, the coverings of the brain will be opened and as much as safely possible of the brain tumor 
will be removed. Since it is impossible to completely remove a recurrent brain tumor, the remaining 
tumor will be injected with the vector producing cells during the operation. 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 each day of surgery. 
Injection of vector-producing cells through the Ommaya reservoir: 
Seven days after surgery additional vector-producing cells will be injected into the area of the 
remaining tumor. This will be performed in the clinic by the neurosurgery staff. There is no need for 
anesthesia. 
Cytovene administration: 
Fourteen days after surgery, Cytovene infusions will be started. Cytovene will be 
administered into a vein by a slow drip lasting about one hour. The drug will be given two times a 
day for 14 days. You may have an MRI or CT scans before, during and after Cytovene therapy. 
Follow-up Care and Evaluation 
After you will 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. An MRI or CT scan of the brain will 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 receive one 
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Recombinant DNA Research, Volume 17 
