D) General or specific alteration in the patient’s condition 
which would render further treatment as unacceptable in the 
judgement of the investigators. 
7.5 Formulation of vaccine 
The established HLA-A2 matched renal cell carcinoma cell lines SK-RC- 
28 and SK-RC-39 infected with the retrovirus NAP-AD/IL2, have been 
shown to secrete IL-2 in excess of 20 U/ml. The stock IL-2 infected cell 
lines are frozen in liquid nitrogen and stored in the laboratories of Drs. 
Bemd Gansbacher and Neil Bander. Approximately one week before the 
vaccination date, vials containing 10 million tumor cells (one for the low 
dose and five for the high dose) will be thawed, expanded in tissue 
culture, and reanalyzed for IL-2 production. These cultures have been 
shown to be free of helper virus, mycoplasma, bacteria, and fungus. 
On the day of the vaccination, the cells will be trypsinized, counted, and 
resuspended in 1 ml of sterile phosphate buffered saline into a sterile 
syringe. The syringe and its contents will be irradiated with 10,000 rads 
and delivered to the outpatient department for subcutaneous injection. 
8.0 EVALUATION DURING STUDY 
8.1 Physical examination while on therapy prior to each vaccine. 
8.2 CBC, platelet count, and differential will be done prior to each vaccine. 
8.3 Chemical profile including liver function tests, bilirubin, creatinine, and 
LDH will be done every four weeks for two months, then prior to each 
vaccine. 
8.4 Peripheral blood will be obtained for immune assays (see section 6.8). 
Two red top tubes and six green top tubes will be obtained prior to 
beginning vaccinations and one to two weeks after the fourth vaccine. 
These will be stored in Dr. Gansbacher’s laboratory. 
8.5 Chest X-ray will be repeated every 4 weeks for two months then prior to 
each vaccine. 
8.6 If moderate to severe toxicity is observed, pertinent tests will be 
performed more frequently than indicated in the table. 
Recombinant DNA Research, Volume 15 
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