Recombinant DNA Advisory Committee - 06/1-2/92 
of cytokines exhibiting anti-tumor responses, via stimulation of specific immunity. 
Dr. Kelley stated that HLA-A2( + ) metastatic melanoma patients will be immunized with 
an allogeneic HLA-A2( + ) melanoma cell line that has been transduced with the 
retroviral vector NAPAD-IL2. The use of an allogeneic tumor obviates the need for 
establishing a cell line for each patient. The allogeneic tumor cells will be irradiated to 
prevent their replication. The investigators will treat 12 patients with a low dose vaccine 
and 6 patients with a high dose vaccine. 
Dr. Kelley noted that the investigators have extensive experience in the treatment of 
melanoma. The protocol is straightforward and reasonable and the clinical monitoring is 
appropriate. 
Dr. Kelley posed several questions to the investigators: (1) What is the persistence of 
irradiated tumor cells in an animal model using allogeneic hosts? (2) Can these 
experiments be performed in an animal model that more closely simulates the treatment 
being proposed for use in humans? (3) Why were in vitro experiments demonstrating the 
persistence of IL-2 secretion performed in melanoma cell lines different from the cell 
lines proposed for human studies? Does IL-2 secretion persist in SK-MEL-29? (4) 
Should patients be excluded from this study if they have received prior autologous or 
allogeneic tumor vaccines? (5) Will patients be monitored for the presence of helper 
virus? and (6) Will there be long-term follow up on these patients? If the investigators 
are able to respond to these questions adequately, this protocol is appropriate for 
approval by the RAC. 
Review-Ms. Meyers 
Ms. Meyers stated that Dr. Gansbacher responded sufficiently to all of her previous 
suggestions regarding the informed consent document. Ms. Meyers stated that this 
document is very readable and understandable. The only remaining concerns she has 
relate to the inclusion and exclusion criteria. The criteria implies that the investigators 
are searching for the healthiest patients rather than the most severely impaired patients 
to enter into this protocol. 
Review-Dr. Bourquin 
Dr. Bourquin stated that the protocol was well written and thought out. There is a slight 
degree of confusion regarding the various revisions of the informed consent document. 
If Ms. Meyers was satisfied with the final version than he was in agreement. 
Presentation-Dr. Gansbacher 
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Recombinant DNA Research, Volume 15 
