Recombinant DNA Advisory Committee - 5/30-31/91 
what is entailed in the procedure. He said he would be happy to revise the informed consent 
document and to incorporate additional comments so that the patient will be able to 
understand what skin and muscle biopsies entail. 
Dr. Lotze then turned to the issue of the PCR assay and its sensitivity. He presented a data 
slide showing a PCR analysis and noted that the sensitivity data was much the same sort of 
data which was provided in the previously approved TIL protocol over a year ago. 
Dr. Gellert said there was no question that laboratories can detect 1 cell in 10^ by PCR 
analysis, however the question still remained as to whether it could be done in Dr. Lotze's 
laboratory. Dr. Anderson responded by saying that the same company which is currently 
providing PCR analysis for his experiments will provide the same service for Dr. Lotze, and 
that as long as the biopsies are taken properly, utilizing rubber gloves and placed in new 
containers, everything else would be automatically taken care of. 
Dr. Leventhal said that if this was such a trivial matter, she was concerned as to why data had 
not been presented previously to the subcommittee and the RAC. Dr. Lotze said that he 
thought the issue of sensitivity had been resolved previously. However, he said this was a 
simple matter and that it could be done quickly. Dr. Gellert said that he would like to see 
such data and that he felt it was clear from the discussion at the HGTS meeting in April that 
such information was to be provided and he was surprised to have not seen it in the new 
package. 
Dr. Mclvor said one of the major concerns in the review of the protocol over the last few 
months had been the inclusion of control tissues to verify that any positive signal from PCR 
in a tumor biopsy sample is actually due to homing of marked TILs to the tumor and not 
simply blood flow through the tumor. He said the only way to answer this question is to take 
muscle and skin biopsies. He said he felt the current informed consent document notifies the 
patient that such biopsies would be taken, but he was not sure it was made clear to the patient 
that this was not associated with an assessment of the antitumor efficacy of the treatment but 
rather the biological characteristics of response from the therapy. 
Dr. Walters noted that in the subcommittee meeting there was discussion as to whether there 
would be a separate consent form for the gene marking portion of the study. He said that in 
fact the motion that was passed asked the investigators to consider devising a separate consent 
form so that it was clear that the TIL cell therapy was one therapeutic protocol and the gene 
marking protocol was something distinct from that. 
Dr. Lotze noted that a revised consent form had been forwarded to ORDA which had 
evidently not gotten into the review materials for today's meeting. However, he produced a 
copy of it and asked that ORDA distribute them to the committee members. 
Mr. Mannix asked if it were possible to approve the protocol subject to the condition that 
PCR sensitivity on the order of 1 in 10^ be demonstrated before beginning to treat patients. 
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Recombinant DNA Research, Volume 14 
