5. Adequate baseline organ function as assessed by the following laboratory values before 
surgery: 
a. Adequate renal function with serum creatinine of <_ 1.5 mg/dL or creatinine 
clearance >_ 45 mL/min/m^ . 
b. Platelet count 100,000 platelets /mm^ 
c. Absolute neutrophil count >_ lOOO/mm^ 
d. Hemoglobin J> 8.5 mg/dL 
e. Normal Partial Thromboplastin Time (PTT), and ProThrombin Time (PT). 
f. Bilirubin <^2.5 mg/dL, SGOT and SGPT < 4X normal. 
g. Patients with a performance status of j< ECOG 3 will be excluded from the study, 
(see appendix H). 
Patients admitted for study under this protocol will be registered with the principal 
investigator at IMMC and the Univ. of Iowa. 
B. Exclusion Criteria: 
Patients with the following conditions will be excluded from the study: 
1. Acute infection. Active infection is defined as any acute viral, bacterial or fungal 
infection which requires specific therapy. 
2. Neurological deterioration. Patients with an increased ICP who require prompt 
reduction of ICP and have a surgically inaccessible lesion will be excluded. 
3. HIV positive patients. 
4. Pregnant patients. 
5. Severe systemic diseases such as severe ischemic heart or lung disease considered to be 
associated with an unacceptable anesthetic/operative risk. 
6. Multiple tumors. 
II. Clinical Evaluation 
A. Preliminary Evaluation and Screening 
The following evaluation must be completed within 30 days of surgery: 
1 . Before a patient can be entered into this study, the investigators must receive information 
from the referring physician(s) detailing the clinical history, general laboratory results, 
specific neurologic and radiologic evaluations, their diagnoses, and all previous therapies 
(Appendix I: Patient Screening Form). 
2. Data substantiating the histopathological diagnosis must be received for review prior to 
participation in the study. If no recent tissue diagnosis is available, the nature of the space 
occupying lesion (e.g. tumor vs. radiation necrosis) will be determined by a stereotaxic 
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. P-HCG serum pregnancy test must be negative within 14 days of surgery (Screening) . 
[ 162 ] 
Recombinant DNA Research, Volume 17 
