6. Renal and hepatic blood chemistries (uric acid, calcium, phosphorus, magnesium, SGOT, 
SGPT, Alkaline Phosphatase, LDH, 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 MRI and/or CT study of the brain 
with contrast enhancement if appropriate. 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, EKG (Screening) . 
12. Immunologic evaluation. 
a. In vitro lymphocyte proliferative responses to mitogen and antigens such as OKT3, 
PHA, Diphtheria, Tetanus, Candida albicans, alloantigen and murine antigens (PA317 
cell). 
b. Cellular phenotype of peripheral blood by FACS analysis 
c. Isohemagglutinins and quantitative immunoglobulins (A,G,M and E) 
d. Serum for antibody to PA317 cells. 
e. Soluble IL-2R 
f. DTH skin test panel (CMI Multitest or equivalent) 
g. Non-serologic HIV test 
13. Freeze baseline sera samples and peripheral blood mononuclear cells. 
B. Evaluations during the treatment period 
1. Before GCV treatment . Patients will be evaluated daily throughout the study. The 
neurological exam will be recorded daily. CT with contrast or MRI scan of the brain will be 
obtained within 48 hours post-operatively depending on the clinical status of the patients and 
scan availability, and again within 48 hours of the infusion of producer cells through the 
Ommaya reservoir. Freeze serum sample and peripheral blood mononuclear cells. 
2. During GCV treatment . Patients will be admitted to the hospital for GCV therapy, for a 
minimum of 48 hours until more information is gained about its use in this patient 
population. A neurological exam will be recorded daily. An MRI or CT scan with contrast 
will be performed at or near the end of the 14 day GCV therapy. Creatinine clearance tests, 
liver function tests, CBC, coagulation studies and blood chemistry will be monitored. Freeze 
serum sample and peripheral blood mononuclear cells. 
C. Evaluation following the treatment period. 
1 . Follow up . A complete neurological and physical examination will be recorded prior to 
discharge. Patients will be seen as outpatients at 2 week intervals for the first 2 months and 
on a monthly basis for one year. Neurological status will be recorded at each follow up visit 
as well as a CT or MRI scan with contrast. The number of visits after the first year will 
depend on the status of the tumor. 
a. CBC differential, platelet count 
Recombinant DNA Research, Volume 17 
[163] 
