during co-cultivation with target cells. Interleukin-2 production 
is measured by enzyme-linked immunoassay (ELISA) and 
stimulation of the reference CTL cell line. Interferon -7 
production is measured by ELISA. Release of additional 
cytokines can be measured by ELISA, including interleukin-4, 
interleukin- 6 , tumor necrosis factor-a, and granulocyte- 
monocyte colony stimulating factor. 
B. Cytotoxic T cell assay. 
Cytoxicity is measured in either a 4 hour or 18 hour 51 -chromium release 
assay (as described in reference 51). 
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 25% increase in the sum of all 
measured lesions or appearance of new lesions. 
10.6 Duration of response: measured from initiation of therapy until a 
25 % 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 
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