3.3 Vaccine Preparation 
Autologous tumor cells (10 7 ) and an appropriate number of M-24 (IL-2) will be admixed, 
resuspended in 0.5- 1.0 ml HBSS and irradiated to 5000 cGy in a cobalt 60 Gamma Cell 
Irradiator (AEC). 
3.4 Vaccine Administration 
The irradiated vaccine will be injected subcutaneously in two subcutaneous deposits on 
either flank in the mid axillary line. The vaccination site will be marked with a small 
India ink tatoo. 
Two hours prior to each vaccine administration, patients will receive an intradermal 
injection of 10 3 irradiated (5000 cGy), untransduced M-24 in a volume of 0.05 ml in 
saline. The skin wheal and erythema will be compared with a positive histamine control. 
4.0 PATIENT SELECTION 
4.1 Inclusion Criteria 
4.1.1 This study is confined to adults over the age of 18. 
4.1.2 Both male and female patients may be enrolled. All patients should be counselled 
regarding the need for effective contraception. Premenopausal females must have 
a negative pregnancy test prior to treatment. 
4.1.3 Patients must be ambulatory with a Kamofsky Performance Status greater than 
or equal to 70 percent. 
4.1.4 Patients must have no evidence of class 3 or greater New York Heart Association 
cardiac insufficiency or coronary artery disease. 
4.1.5 No evidence of opportunistic infection. 
4.1.6 A minimum of 4 weeks must have elapsed since the completion of prior 
chemotherapy or radiation therapy. 
4.1.7 Adequate baseline organ function as assessed by the following laboratory values 
within 30 days prior to study entry (day -30 to 0): 
► Adequate renal function with estimated creatinine clearance > 50 
ml/ min. This will be determined by serum creatinine and 24-hour 
urine creatinine ordered concurrently. 
► Adequate liver function with SGOT, SGPT and alkaline 
phosphatase <_ 5 times the ULN [if transaminases > than the 
upper limit of normal (ULN), patients should have a hepatitis B 
Recombinant DNA Research, Volume 18 
[423] 
