VII. Evaluation and Follow Up. 
A. Evaluation during the treatment period: 
1. Before GCV treatment. Patients will be evaluated daily throughout the study. For the 
first 48 hours following the surgical procedure, they will be under continuous monitoring 
in the Surgical ICU. 
The neurological exam will be recorded daily. MRI scan of the brain will be obtained on 
the first and fifth post-operative day depending on the clinical status. 
2. Purina GCV treatment. Patients will return to the Surgical ICU for GCV therapy, for a 
minimum of 48 hours. A Neurological exam will be performed and recorded twice a day. 
An MRI study, with and without gadolinium, will be performed at least weekly beginning 
on the second day of GCV therapy. Creatinine clearance tests, liver function tests, CBC 
with differential count, coagulation studies and blood chemistry will be closely 
monitored. 
B. Evaluation following the treatment period. 
1. Follow up. Patients will be prepared for discharge upon completion of the GCV 
course of treatment. A complete neurological and physical examination will be 
recorded prior to discharge. Patients will be seen as outpatients at 2 weeks 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 gadolinium enhanced MRI, blood chemistry 
and CBC. The number of visits after the first year will depend on the status of the tumor. 
2. Yearly follow-up laboratory evaluation. 
Patients will be requested to be followed once a year for the rest of their life for retroviral 
gene transfer safety monitoring. 
a. CBC with Differential count 
b. Repeat Immunologic evaluation. 
c. Serum for antibody to PA317 cells. 
d. PCR on mononuclear cell DNA for vector sequences 
e. Western analysis of serum for antibody to retroviral antigens 
f. If at any time a new malignancy develops, we shall attempt to obtain involved 
tissue for analysis for the vector DNA. 
Recombinant DNA Research, Volume 15 
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