not be considered a sufficient indication for the termination of the study. Any 
additional occurrence of toxicity will be discussed with the Chairman of the ARB. 
3. Upon request of the participating patient or the person with the power of attorney 
the patient may withdraw from the study. 
III. Data Collection and Monitoring 
1. Study monitoring. The investigators will allow study monitors and the FDA to inspect 
study documents (e.g. consent forms, certificate of analysis, case report forms, 
and pertinent hospital or clinical charts.) 
2. Reporting of adverse reactions. Adverse Reactions (ADRs) will be reported 
promptly to the FDA, IRB, and IBC. ADR reports are required even if only a 
suspicion of a drug effect. Previously unknown Grade 2 or 3 reactions will be 
reported in writing within 10 working days. Grade 4 (life-threatening) reactions 
and patient deaths while on treatment will be reported by phone within 24 hours. 
A written report will follow within 10 working days. 
3. Protocol amendment procedures. Any revisions to the original protocol will be 
discussed by all investigators, the FDA and others as required. If the consensus 
is to revise the current protocol, a formal list of changes will accompany the 
amended protocol and these will be submitted to the FDA, BCM's IRB, and other 
pertinent committees. 
4. Publications resulting from the trial. Any manuscript, abstract, or presentation will be 
available to all the study investigators involved in this protocol. 
IV. Nature of Procedures and Therapeutic Agents 
A. Surgery 
As defined above in "Selection Criteria", patients who have a biopsy-proven malignant 
glioma or metastatic tumor are candidates for treatment. 
1. Anesthesia: 
Monitored anesthesia care for setting the stereotaxic frame and CT/MRI 
scanning. Monitored anesthesia care or general endotracheal anesthesia for the 
biopsy and virus injection depending upon the location of the tumor and the 
cooperation of the patient. 
2. Operative procedure: 
a. Setting the stereotaxic frame and obtaining coordinates for the tumor. The 
patient is brought into the operating room where the scalp is scrubbed with 
Betadine. The stereotaxic frame pressure points are infiltrated with Lidocaine 
and a Leksell G frame is fitted to the patient's skull. The patient is taken to the 
CAT scanner where the lesion is localized in relation to the stereotaxic frame 
using intravenous contrast material in the majority of cases. The CAT scan is 
compared to MRI scans performed before the operation. The coordinates of the 
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