greatest cross sectional diameter times the greatest diameter perpendicular to it on enhanced CT or MRI. 
Technical parameters for the evaluation scan will be identical to those used for the baseline scan. 
MRI methods routinely utilized in brain tumor clinical trials will be employed in our study. We are aware 
of the importance of employing uniform procedures for the performance and evaluation of MRI scans in 
monitoring tumor responses to therapy. A sagittal T1 weighted sequence will be performed initially using 
a TR of 600 and a 20 msec echo. An axial spin echo sequence with flow compensation will then be 
performed using a TR of 3000 with 30 and 80 msec echoes. Gadolinium will then be injected 
intravenously and contiguous 5 mm axial T1 weighted scans will then be performed through the entire 
brain using a TR of 800 and a 30 msec echo. Post contrast coronal T1 weighted scans will then be 
performed using a TR of 800 and a 27 msec echo. Tumor responses will be evaluated by comparing the 
tumor's largest cross sectional area as measured by the greatest cross sectional diameter times the 
greatest diameter perpendicular to it on enhanced MRI. Technical parameters for the evaluation scan will 
be identical to those used for the baseline scan. All of the MRI scans will be evaluated and performed 
under the direction of Dr. Keith Kortman, an experienced neuroradiologist. 
9.3.2 A neurological examination will be performed and compared with the pretreatment 
examination. 
9.33 A Kamofsky performance will be recorded and compared with the pretrement score. 
9.34 Medications and their dosages, including steroids, and laboratory data will be recorded in 
accordance with the study parameters above. 
9.35 Response will be defined by the criteria of MacDonald as summarized below. 
Complete Response (CR): complete disappearance of all enhancing tumor on consecutive CT or 
MRI scans, off steroids and neurologically stable or improved. 
Partial Response (TRI : 50% or more reduction of contrast enhancing tumor area, steroid dose 
stable or reduced and neurologically stable or improved. 
Progressive Disease fPDI : 25% or more increase in contrast enhancing tumor area or new tumor 
focus. 
Stable Disease (SDV . All other situations. 
9.36 CR, SD and PR will be considered responders; PD, and patients not evaluated after 2 
cycles of treatment will be considered non-responders. 
10.0 Data Submission 
The following forms must be submitted to the study chair according to the following schedule: 
Forms Schedule 
N-OOl On-study form Within one week of registration 
N-002 Neuropathology Form 
N-004 Flow Sheets 
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