7.2 Maximum Tolerated Dose (MTD) 
ij The maximum tolerated dose (MTD) is defined as that dose of IL-2 secreting cells which results in 
J>_ grade 3 toxicity or which causes a delay in day 14 immunization in >_ 3/6 patients in any treatment 
cohort. Day 14 treatments must be delayed if any _>_ grade 2 toxicity has not reversed to _<_ grade 1. 
8.0 Study Parameters 
8.1 Pre-treatment Evaluations 
( The following pre-treatment evaluations will be performed (8.11-8.14): 
8.1.1 History and Physical Examination 
;| These evaluations will include a description and quantitation of disease activity. 
8.1.2 Performance Status Assessment 
I See Appendix 12.2 for Kamofsky Performance Status assessment. 
8.1.3 Pre-treatment Laboratory 
j CBC with differential, platelet count, PT, PTT, glucose, BUN, creatinine, electrolytes, SGOT, 
SGPT, LDH, alkaline phosphatase, bilirubin, uric acid, calcium, total protein , albumin, amylase and 
lipase. 
Urinalysis 
[| 
j CHso, C3 and C4 serum complement levels 
Immunophenotyping of peripheral blood B cell and T cell subsets (if sufficient cells are available) 
PCR of peripheral blood leukocytes for neo^ and viral env 
Serum IL-2 concentration 
Humoral tumor immunity - serum anti-tumor titers 
Cellular tumor immunity - Cytotoxic T cell assays against autologous tumor cells. Delayed type- 
hypersensitivity (DTH) skin testing will be performed at the discretion of the investigators and 
depending upon the availability of tumor cells. Aliquots of 10° autologous tumor cells will be utilized 
for DTH skin testing. The cells will be drawn up in 0.2 ml of normal saline and injected 
intradermally. Induration will be measured at 24 and 28 hours. A medium ball point pen will be 
placed at 45° angle to the patient's skin, and the injection site approached from each of 4 sides until 
resistance is encountered. The area thus circumscribed will be measured in 2 diameters with a 
caliper. Selected DTH sites may be biopsied for histological and immunohistochemical analyses to 
identify the nature of infiltrating immune effector cell populations. 
8.1.4 Other Pretreatment Evaluations 
s 
j Chest X-ray and other diagnostic studies including computerized tomography (CT), magnetic 
resonance imaging (MRI) or radionuclide scans will be performed to document and quantitate the 
extent of disease activity. 
Recombinant DNA Research, Volume 18 
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