Human Gene Therapy Subcommittee - 11/30/90 
radiolabeled, H^2-expanded, non-TILs taken from the peripheral blood and compare 
their homing to tumor sites with TIL homing. 
Dr. Lotze said the payment issues are germane to the study. This issue has been 
addressed at NIH as well as at Pittsburgh and is not unique to the academic setting. 
No patient would be charged for TIL treatments, and the University of Pittsburgh 
was committed to paying for TIL production. However, this willingness to pay may 
not continue in the future, and discussions are currently taking place with the 
university. 
Dr. Lotze said that the policy of exclusion of pregnant women has been traditional 
for experimental chemotherapy or immunotherapy. This broader social issue is 
beyond the scope of the narrow confines of the HGTS. 
Dr. Lotze said that he and his collaborators are planning extensive studies to 
examine the presence of TILs in tumor. They will attempt to develop monoclonal 
antibodies and polyclonal antibodies to the neomycin phosphotransferase genes and 
perform in situ hybridization as potential vehicles for determining the location of 
TILs within tumor, as well as quantitate them. Tumor tissue obtained from patients 
will be cryopreserved so that once these techniques are available, the tissues can be 
analyzed. 
Dr. Lotze said that he has been in communication with Dr. Rosenberg. The NIH 
and that Dr. Rosenberg's group does not intend to pursue evaluation of IL-4 in its 
homing studies. Therefore, this study is not a duplicate of the Rosenberg protocol 
and should not be viewed as such, but rather as an attempt to improve TIL therapy. 
If the concurrent administration of IU2 and IL-4 produces better homing of TILs to 
tumor, the protocol will have proved beneficial. 
Dr. Parkman asked if data derived from previous studies with melanoma patients 
that demonstrates the combination of IL-2 and IL-4 resulted in a clinical response. 
Dr. Lotze said that there had been quite a dramatic response has been seen in 
patients with major tumor regression in liver, abdominal wall, cutaneous sites, and 
nodal sites. 
Dr. Parkman said it seemed appropriate to study IL-2 and IL-4 TIL therapy to look 
at clinical response, but the reason given for introduction of the neomycin resistance 
gene was to quantitate homing. With the lack of ability to differentiate tumor- 
specific homing of TIL versus TILs being present because of the peripheral 
circulation, this experiment will not provide any more data than the Rosenberg 
protocol. Dr. Lotze said that a comparison of TILs found at the site of the tumor 
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Recombinant DNA Research, Volume 14 
