KEY TO CODE OF FREQUENCY OF STUDY OBSERVATIONS 
CODE 
A. D-7 , -2 , 0, 1 , 2 , 3 , 4 , 5 , 7 , 8, 9 , 10, 14 , 21 , 26 , 28 for each treatment cycle or more 
frequently as indicated 
B. D-7 , D-2 , 0, 2 , 5 , 8, 14, 28 or more frequently as clinically indicated. 
C. D-0, 14,21,28 
D. D-7, 28, 84, every 6 months ofl Stage 3 of trial. 
E. Conducted per FDA regulations on vaccine cells and stored patient 
specimens in Stage 3. 
F. D-7 baseline data, if the urinalysis shows an active sediment or Cr is 
elevated by 20% over two determinations then renal scan will be repeated 
to assess GFR change. 
G. D27, D84 or as clinically indicated by tumor response clinically 
H. D3 , D7 , D59 , D63 
I. D4-7 whenever draining LN is at least two fold greater in one dimension 
measure 
J. D-2, DO, D26, D28 , D82, D84 
K. DO, D28 , D56, D84 Then every 2-3 months as clinically indicated or more 
frequently if clinically indicated 
L. First Cycle Vaccination: pre-injection ,6 hours, 24 hours, 48 hours, 120 
hours . 
M. D-7, then as clinically indicated 
N. Tumor specific CTL attempted to be cloned from draining lymph 
nodes, first treatment cycle only. 
Tumor specific CTL attempted to be cloned from peripheral blood 
following vaccination 
Tumor specific CTL attempted to be cloned from biopsied draining 
limb lymph node post-vaccination 
O. D-7, D28, D56, D84, every 6 months 
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