8. Immunological studies - Presence of serum neutralizing antibodies to wild-type 
adenovirus. 
9. Microbiology studies - Presence of adenovirus in serum, urine and nasal swabs. 
10. Neuropsychological tests - Patients will receive a battery of neuropsychological 
tests prior to surgery to establish a baseline for post-therapy tests. (Appendix B) 
B. Evaluations during the Treatment Period 
The following clinical tests will be performed during the 2 week period of GCV 
administration: 
1. Physical and neurological examinations - Examinations will be performed daily while 
the patient is hospitalized, and then will be performed at each patient visit. 
2. Imaging studies - MRI and/or CT scans of the brain will be obtained within 48 hr 
after surgery and approximately 1 week after completion of the course of GCV 
therapy. 
3. Chemistries - Creatinine liver function tests, CBC, coagulation studies and blood 
chemistries will be monitored as indicated. 
4. Immunological studies - Presence of serum neutralizing antibodies to adenovirus 2 
weeks after virus injection. 
5. Microbiology studies - Presence of adenovirus in serum, urine and nasal swabs 2 
weeks after virus injection. 
C. Evaluations following the Treatment Period 
1 . Patients will be seen as outpatients at 2 week intervals for the first 2 months and on 
a monthly basis for one year. During the second year after treatment patients 
will be followed at two month intervals. Evaluations will include: 
a. Laboratory tests as required for standard neurosurgical care. 
b. Physical examination with a detailed neurologic exam. 
c. MRI scans will be obtained ever 12 weeks. 
d. A neuropsychological exam will be performed 2 months after surgery. 
(Appendix B) 
e. The presence of recombinant adenovirus in serum, urine, and nasal swabs. 
The presence of antibodies to adenovirus in serum. 
2. Patients will be requested to be evaluated once a year for 5 years. Evaluations will 
include: 
a. Physical and neurological examination including an MRI. 
b. CBC with differential count. 
c. Serum antibodies to adenovirus. 
d. Neuropsychological examination, if examination. 
Recombinant DNA Research, Volume 20 
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