Liver (SCOT, alk phos, and X 
total bilirubin) 
X 
11.0 Treatment Evaluation 
11.1 Patients will be evaluated by in the Hematology /Oncology clinic at the 
University of Chciago at least every 4 weeks while receiving treatment, every 
8 weeks until there is evidence of tumor progression, and then 8-12 week 
intervals thereafter as long as the patient is able to return to the University of 
Chicago. 
11.2 Evaluation of tumor regression is a secondary endpoint in this clinical 
trial. The following criteria will apply to measurable indicator lesions: 
11.3 Minimum size requirements for measurable indicator lesions: 
11.3.1 Tumor masses with clearly defined bidimensional measurements. 
The minimum size of the indicator lesion depends on the method 
of measurement as follows: 
Method of Measurement Minimum Size of Largest 
Tumor Diameter 
Physical examination or 1.0 cm 
chest x-ray (discrete lesion 
that can be measured with 
calipers) 
CT Scan* 3.0 cm 
* Note: Special attention should be paid to identify the specific lesion being measured, and 
to define an anatomic landmark to identify the level of the cross-sectional image to facilitate 
serial measurements. Lesions 2.0-3. 0 cm in diameter may be used as indicator lesions if 
serial images are obtained at 0.5 cm intervals through the tumor. 
11.4 Criteria for a partial response (PR). 
11.4.1 Bidimensional indicator lesion(s). 
50% reduction in the sum of the products of the largest 
perpendicular diameters of the indicator lesion(s), single or 
multiple sites, chosen prior to therapy. Response status will be 
determined separately for the injected tumor nodule and other 
measurable lesions that are not injected. 
11.5 Criteria for complete response (CR). 
Total disappearance of all evidence of tumor. 
For a patient to qualify for complete response or partial response, none of 
the factors constituting progression may be present (see below). 
11.6 Criteria for progressive disease (PD): 
Tumor progression will be declared if one or more of the following 
criteria are met. 
11.6.1 Appearance of new lesion(s). 
11.6.2 Increase in tumor size. 
11.6.2.1 Patients with measurable indicator lesion(s) who 
have met the criteria for partial response. 
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