necessitating hospitalization, that patient will not receive subsequent 
vaccinations. 
7.4 Criteria for removal from study: 
A. Progressive disease other than appearance of small (< 2 cm 
diameter) superficial cutaneous, subcutaneous or soft tissue 
metastases. If small superficial disease appears, the patient may 
continue with vaccination at the discretion of the investigator. 
B. Severe intercurrent Illness. 
C. Unacceptable grade 4+ toxicity. 
D. General or specific alteration in the patient’s condition which 
would render further treatment as unacceptable in the judgement of 
the principal investigators. 
7.5 Formulation of vaccine 
The established HLA-A2 melanoma cell line SK-MEL-29 infected with 
the retrovirus NAP-AD/IL2 has been shown to secrete 40 U IL-2/ml. 
The stock IL-2-infected cell line is frozen in liquid nitrogen and stored in 
the laboratory of Dr. Bemd Gansbacher. Approximately one week before 
vaccination date, vials containing 10 million tumor cells (one vial for low 
dose and five vials for high dose) will be thawed, expanded in tissue 
culture, and reanalyzed for IL-2 production. These cultures will 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 (USP) 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 
by a Principal Investigator or a designated co-investigator. 
8.0 EVALUATION DURING STUDY 
8.1 Physical examination prior to each vaccination. 
8.2 CBC, platelet count, and differential will be done prior to each vaccine. 
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