biopsy of the lesion prior to cell injection. 
3. Pretreatment general physical examination and a 
comprehensive neurologic evaluation ( Screening ) . 
4. HIV test (must be negative) ( Screening ) . 
5. B-HCG a pregnancy test must be negative within 14 days 
of surgery in children of child bearing potential. 
6. Renal and hepatic blood chemistries (uric acid, calcium, 
phosphorus, magnesium, SGOT, SGPT, Alkaline Phosphatase, 
LHD , total bilirubin, BUN, creatinine, albumin, total 
protein, amylase, electrolytes, glucose) ( Screening) . 
7. Urinalysis ( Screening ) 
8. PT, PTT, fibrinogen (Screening) 
9. CBC with differential and platelets (Screening). 
10. Radiological Evaluation. Each patient will undergo an 
MR and/or CT study of the brain with contrast 
enhancement. Preliminary decisions regarding the 
eligibility of the patient for treatment, and the 
injections and/or procedures needed for each patient will 
be decided based on these studies ( Screening ) . 
11. CXR 
12. Freeze baseline serum and peripheral blood mononuclear 
cells to allow testing for antibody and T-cell reactivity 
to PA317 cells. 
B. Evaluations during the treatment period 
1. Physical examination to include neurologic examination will 
be performed at each patient visit. Patients will be 
evaluated weekly at a minimum throughout the treatment period. 
2. MR scans of the brain will be obtained without 48 hours after 
surgery and approximately 1 week after completion of each 
course of GCV therapy. Standard neurosurgical follow-up will 
be employed. CT scan may also be obtained if indicated. 
3. Creatinine clearance tests, liver function tests, CBC, 
coagulation studies and blood chemistry will be monitored as 
indicated. 
C. Evaluation following the treatment period. 
1. Patients will be seen as out-patients at 2 week intervals for 
the first 2 months and on a monthly basis for one year. 
During the subsequent year patients will be followed at two 
month intervals. 
a. Laboratory tests as required for standard 
neurosurgical care. 
b. Physical examination with a detailed neurologic 
exam. 
c. MR scan will be obtained every 4-8 weeks. These 
scans will be used to assess the status of the 
patient's tumor. A patient will be considered to 
have failed therapy if there is evidence of tumor 
growth on a follow-up scan. 
d. B-HCG a pregnancy test will be repeated monthly for 
women with child bearing potential while on therapy. 
e. Radiological evaluation: Patients will have a CT 
scan or MR scan of the brain (if needed) with 
contrast enhancement if appropriate. 
f . Freeze serum and peripheral blood mononuclear cells. 
Recombinant DNA Research, Volume 18 
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