July 30, 1990, Human Gene Therapy Subconmittee 
6. Do TNF-TIL respond to steroids? 
Dr. Mclvor asked if Dr. Rosenberg knew whether TIL^nf responds to steroids in vitro. 
Dr. Rosenberg said he didn't know, but that an ID2 dependent cell in the presence of 
IL-2 will not be affected by steroids in vitro. However, in the absence of IL-2 and in 
human studies in which steroids were administered in the presence of LAK and IL-2, the 
steroids produced a marked reduction in 11^2 toxicity in the patients and allowed one to 
give 11^2 longer without seeing toxicity. 
7. What is the current situation with respect to the availability of anti-TNF 
antibody? 
Dr. Mclvor said this issue had been satisfactorily addressed. 
8. How were the TIL infections performed considering the low titer of the 
virus? 
Dr. Mclvor said this issue was addressed by Dr. Rosenberg's comments. 
9. How many dry runs have been performed and what is the Southern data 
on these? Is proviral structure and copy number maintained? Are these 
data available to see? 
Dr. Mclvor said he would still like to see additional Southern data on material from 
other patients and other dry runs which Dr. Kasid has agreed to provide. 
10. What is the current status of marked TIL trafficking studies? Do they 
support homing at a level of .015% per gram? 
Dr. Mclvor asked if the N2/TIL protocol had provided any further insight into this 
question. Dr. Rosenberg said it had not, and they had not been able to get a good 
estimate of the incidence of marked cells at the tumor sites. He said it could be done in 
a single-cell suspension from peripheral blood but not from the tumor. He said he felt 
the indium^^^ studies were done quite carefully and are more reliable. 
11. In human experiments, how will one determine what part of the efficacy 
can be attributed to TNF gene transfer and expression? 
Dr. Mclvor called Dr. Rosenberg's attention to a sentence on page 146 of the proposal 
that states that, "...detailed studies of patient toxicity, as well as possible therapeutic 
effects, will be noted." He asked if these therapeutic effects were meant to be those 
specifically attributed to TNF, or just overall therapeutic effects. 
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Recombinant DNA Research, Volume 14 
