250% 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 progression (PROG) 
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. 
Significant increase in the size of indicator lesion(s) 
compared to the smallest measurements while on 
study. 
Progression will be declared when the indicator 
lesion has increased in size from the smallest 
measurement by at least 50% of the decrease in size 
between pre-treatment measurements and smallest 
measurement at the point of maximum tumor 
reduction. 
11.6.2.2 Patients with measurable indicator lesion(s) who 
have met the criteria for complete response: 
Progression will be declared if there is reappearance 
of any tumor. 
11.6.2.3 Patients with measurable indicator lesion(s) 
compared to pre-treatment measurements. 
11.6.3 Significant clinical deterioration that cannot be attributed to 
treatment or other medical conditions. 
11.6.3.1 Weight loss >5% body weight. 
11.6.3.2 Worsening of tumor-related symptoms. 
11.6.3.3 Decline in performance status >1 level on ECOG 
scale. 
11.7 Criteria for stable (STAB) 
Failure to meet the criteria for complete response, partial response, 
regression, or progression. 
12.0 Descriptive Factors - None 
13.0 Treatment/Follow-up Decision at Evaluation of Patient 
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