Physical exam 
Concomitant medications 
Vital signs 
Weight 
Kamofsky Performance status 
CBC with differential, platelet count 
Serum chemistry 
Urinalysis 
Coagulation profile (PT, PTT) 
Tumor assessment 
Cytokine assays, only during weeks 28 and 40 (serum IL-2 and alpha interferon) 
Antibody assays, only during weeks 28 and 40 (anti-rIL-2 and anti-rHuIFN- 
alpha 2a) 
Cytotoxicity of peripheral blood cells, only during weeks 28 and 40 
(K562, Daudi, LDCC) 
After week 52, patient evaluation and tumor assessment may continue if disease 
progression has not occurred. 
12. TUMOR ASSESSMENT 
12.1 Tumor parameters are defined as the product of two perpendicular diameters of 
marker lesions, in centimeters (cm), applied at the widest portion of the tumor. 
12.2 In the event of extensive metastases, sentinel lesions may be selected for 
determining the efficacy of the study treatment. Sentinel lesions are defined as 
those lesions existing at baseline, which, in the clinical opinion of the investigator, 
most clearly represent the state of disease. Sentinel lesions will be selected before 
treatment begins and should not be previously irradiated fields, unless progression 
has occurred. The liver itself cannot be used as a sentinel lesion, although lesions 
within the liver are acceptable. The minimum acceptable size of the lesions will 
depend upon their number and dimension as outlined in the following table: 
Number of 
Lesions 
1 
Dimension 
Bidimensional 
Minimum 
Size 
1.0 cm x 1.0 cm 
>1 
Bidimensional 
0.5 cm x 0.5 cm 
Recombinant DNA Research, Volume 15 
[535] 
