10.0 CRITERIA FOR A THERAPEUTIC RESPONSE 
10.1 Complete Response (CR): Disappearance of all clinical evidence of 
tumor on physical examination, x-ray, and biochemical evaluation, 
for a minimum of 4 weeks. 
10.2 Partial Response (PR): Greater than 50% decrease on physical 
examination or radiography (including CT scan and/or ultrasound) of 
the summed products of the perpendicular diameters of all measured 
lesions maintained for a minimum of 4 weeks. No simultaneous 
increase in size of any lesion or the appearance of any new lesion 
may occur. 
10.3 Minor Response (MR): 25-49% decrease in the summed products of 
diameters of measured lesions for a minimum of 4 weeks. 
10.4 Stable Disease (STAB): Less than 25% decrease or increase in 
tumor size for at least 3 months. 
10.5 Progression (PROG): Greater than 50% increase in the sum of all 
measured lesions or appearance of new lesions. Note that if there is 
the appearance of superficial cutaneous, subcutaneous or soft tissue 
disease < 2 cm diameter, the patient may continue with vaccination 
at the discretion of the investigator. 
10.6 Duration of response: measured from initiation of therapy until a 
50% or greater increase from the smallest sum of all tumor 
measurements obtained during best response (CR, PR, MR, or 
STAB). 
11.0 CRITERIA FOR TOXICITY 
Toxicity will be graded and classified according to Common Toxicity Criteria 
(Appendix) by the following outline: 
0 No toxicity 
1+ Mild toxicity, usually transient, requiring no special treatment and 
generally not interfering with usual daily activities. 
2 + Moderate toxicity ameliorated by simple maneuvers. 
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Recombinant DNA Research, Volume 15 
