y an 
""Miff* 
Three sentinel lesions may be selected for assessment and followed instead of multiple 
lesions. 
12.3 Tumors will be assessed prior to the nephrectomy, at baseline, and at weeks 6, 
12, 18, and 24 during the treatment period. During the post-treatment follow-up 
period, the tumors will be evaluated monthly until the disease progression if CAT 
scans are not required to evaluate the tumors, or every three months until disease 
progression if the tumors are evaluated using CAT scans. Assessment should also 
be performed when clinically indicated or upon withdrawal from the clinical trial. 
13. CRITERIA FOR CLINICAL RESPONSE 
13.1 Anti-tumor response will be determined according to the criteria established the 
World Health Organization 15 . 
13.2 The definition of a Complete Response (CR) is the disappearance of all clinically 
detectable disease for a period of at least four consecutive weeks after the 
completion of the treatment period. 
13.3 The definition of a Partial Response (PR) is a 50 percent or greater decrease in 
the sum of the products of die two greatest perpendicular diameters of the 
measurable lesions for a period of at least four weeks. No simultaneous increase 
in the size of any lesion or the appearance of a new lesion may occur. 
13.4 The definition of a minor response (MR) is a 25 percent or greater decrease in the 
sum of the products of the two greatest perpendicular diameters of the measurable 
lesions for a period of at least four weeks. No simultaneous increase in the size 
of any lesion or the appearance of a new lesion may occur. 
13.5 The definition of no change in tumor (NC) is defined as < 25 percent increase or 
decrease in the size of the tumor and no lesions for at least four weeks after 
completion of the treatment period. 
13.6 The definition of progressive disease (PD) is a >25 percent increase in the tumor 
size as defined above. Appearance of new lesions will also constitute progressive 
disease. 
14. TIL PROCESS EVALUATION 
For use directions see the CELLector™ CD8 and CD4 Cell Culture Flask Operator 
Manual. 
[536] 
Recombinant DNA Research, Volume 15 
