V. PROTOCOL: 
I. Selection of Patients 
A. Inclusion Criteria 
Protocol 
1 . Adults with recurrent high grade astrocytomas or glioblastoma multiforme or metastatic 
tumors identifiable by CT and/or MRI scan. Tumors must be biopsy proven. 
2. Patients must have received all potentially curative treatments and currently have 
evidence of progressive disease demonstrated by diagnostic imaging studies and 
tumor demonstrated by biopsy. 
3. Patients must have a single tumor and of no more than 64 cm 3 in volume (e.g. no more 
than approximately 4cm x 4cm x 4cm in dimension). The tumor must not be in the 
brain stem or in any other area in which a standard tissue resection would produce an 
unacceptable neurological deficit. 
4. The patient may not have had cytotoxic chemotherapy within 6 weeks of initiating this 
protocol and may not have had radiation therapy to the brain within 8 weeks of 
initiating this protocol. 
5. Male or female patients >18 years of age. 
6. Possess the ability to give informed consent and express a willingness to meet all the 
expected requirements of the protocol for the duration of the study. 
7. 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 2 . 
b. Platelet count >100,000 platelets/mm 3 . 
c. Absolute neutrophil count >1 000/mm 3 . 
d. Hemoglobin >8.5 mg/dL. 
e. Normal Partial Thromboplastin Time (PTT), and Pro-Thrombin Time (PT). 
f. Bilirubin <2.5 mg/dL, SGOT and SGPT < 4X normal. 
8. Due to contraindications of ganciclovir treatment women may not be pregnant and, if of 
child bearing potential, must practice strict birth control to prevent pregnancy for the 
duration of the study. Men must use barrier protection for the duration of the study. 
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. Patients with an increased ICP who require surgical reduction of the tumor mass 
will be excluded. 
Recombinant DNA Research, Volume 20 
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