Recombinant DMA Advisoiy Committee - IfAiftX 
ADMINISTRATION OF INTERLEUKIN-2, INTERLEUKIN-4, AND TUMOR 
INFILTRATING LYMPHOCYTES TO PATIENTS WITH MELANOMA": 
Dr. Gellert said that he and Drs. McGarrity, Mclvor, and Carmen had reviewed both the 
original and revised protocols over the coffee break and it was thought that there are 
still some problems that need further work before the protocol can be approved. The 
main concern was stipulation by the HGTS that the homing experiments and their 
analysis needed clarification, was not yet completely addressed. The revised protocol did 
not contain an adequate technical description of what will be done. A further point was 
that the consent form should explicitly state that the gene tagging will offer no 
therapeutic benefit to the patient. Additionally, there are still problems with the 
description of how payment will be handled and what costs the patient will bear in 
regard to the protocol. Finally, there was very sparse inclusion of preclinical data and 
that the data on the results of treatment of patients with cells cultivated in IL-2/IL-4, 
which were reported by Dr. Lotze, still were not included in the protocol. 
Dr. Mclvor added that there was concern over the specific type of protocol to be used 
and the awareness of the patient. Dr. Gellert said that since this was a compendium of 
five different protocols, only one of which was of concern to the RAC, some clarity 
needed to be provided in how the patients will be sorted into the various protocols and 
to what extent the patient has a choice in which protocol he participates in. 
Dr. R. Murray said that there were portions underlined on pages 3 and 7 of the revised 
protocol regarding the absence of benefit from the gene marking and payment for 
development of cells. Dr. Gellert said that this did not address payment for injuries 
resulting from the protocol and this was his main concern. The third party payers often 
sever their connection with the treatment and throw the responsibility back on the 
patient for payment in these instances and clarification is needed as to who will pay for 
treatment of such injuries. 
As far as the lack of benefit from the gene insertion. Dr. Gellert said that he had 
overlooked this and this fulfilled that criterion. 
Dr. Walters said that if the only issue was that of payment for injury caused by the 
protocol, it would not be sufficient cause to delay approving the protocol since this is a 
universal problem that all institutions must deal with. However, the issues of preclinical 
data were more substantive issues in his mind. 
Dr. McGarrity felt that a formal motion was necessary, but that it was apparent that the 
RAC could not approve this protocol on the basis of the revised documentation. He 
underlined that Dr. Lotze should present documentation addressing the points mentioned 
by Dr. Gellert first to the HGTS and then, if the subcommittee was satisfied with the 
Recombinant DNA Research, Volume 14 
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