and 20 ml. of unheparinized blood for baseline immunological studies 
will be obtained. Antibody mediated immunity to melanoma will be 
measured by enzyme immunoassay and complement-dependent 
cytotoxicity. 
b. Cell mediated immunity to unmodified autologous melanoma target 
cells will be measured using a chromium release assay. 
4.8 SCHEDULE FOR TUMOR MEASUREMENTS: 
A. Measurements of evaluable lesions will be made prior to therapy and every 
other week for 3 months and monthly thereafter. 
B. X-rays of evaluable lesions will be taken at weeks 1, 8 and 16; CT scans of 
evaluable lesions will be completed at weeks 8 and 16 and additional scans will 
be obtained as clinically indicated. 
C. Additional tumor measurements will be made of all objective partial or 
complete responses. 
Definitions for patient responses: 
CR - COMPLETE RESPONSE 
During an observation, no disease is apparent and no evidence of disease is observed 
for at least 28 days following the preceding evaluation. 
PR - PARTIAL REPONSE 
A 50% or greater decrease from baseline in overall tumor size is noted, and no 
progressive disease is observed for at least 28 days following the observation of the 
50% decrease. 
SD - STABLE DISEASE 
The patient has stable disease if he/she does not exhibit at least a 50% decrease in the 
overall size of all lesions. In addition, no new lesions may have appeared. 
PD - PROGRESSIVE DISEASE 
Progressive disease will be measured with reference to baseline values unless a 
decrease in size has been observed. A 50% or greater increase in the size of any single 
lesion or the appearance of a new lesion constitutes progressive disease. 
[6421 
Recombinant DNA Research, Volume 17 
