Human Gene Therapy Subcommittee - 4/5/91 
the motion. 
Dr. Walters noted the motion for provisional approval with two conditions: the request 
for quantitation of the PCR assays and the request for a separate consent form that 
deals only with the gene marking portion of the study. Dr. Epstein seconded the motion. 
Dr. Walters asked for further discussion. 
Dr. McCarthy asked for a clarification of the statement in the consent form "The study is 
monitored by NCI." The patient might be led to believe his or her safety and risks are 
being monitored by NCI, whereas NCI will only follow the collection of data. 
Dr. Lotze explained that the Cancer Therapy Evaluation Program of the NCI will supply 
the IL-2 and IL-4 for the therapy, and that they monitor very carefully information 
regarding toxicity, efficacy, and some laboratory parameters of the experimental question 
being addressed. 
Dr. McCarthy asked if there would be a Data and Safety Monitoring Committee with 
authority to stop the administration of the therapy. Dr. Leventhal suggested they change 
the phrase to "The NCI will have access to your records." 
Ms. Meyers asked to see a revised informed consent form prior to the protocol being 
sent to the RAC. Dr. Parkman suggested the subcommittee prepare a short list of who 
would like to see the consent form. 
Dr. Lotze restated his understanding that the committee would like a revised consent 
document which separates the IL-2/IL-4 TIL component from the more experimental 
gene-marked TIL component. 
Dr. Walters called for a vote on Dr. Parkman's motion to give provisional approval with 
the stipulation that more information be provided about the quantitative assays of gene- 
marked tumor infiltrating lymphocytes. It was requested that the consent form 
concerning the gene marking of tumor infiltrating lymphocytes be separated from the 
consent form regarding interleukin-2 and interleukin-4 therapy. The motion passed by a 
vote of 9 in favor, 1 opposed, and no abstentions. 
VI. AMENDMENT TO THE POINTS TO CONSIDER IN THE DESIGN AND 
SUBMISSION OF PROTOCOLS FOR THE TRANSFER OF RECOMBINANT DNA 
INTO THE GENOME OF HUMAN SUBJECTS: 
Dr. Walters noted that Dr. Mclvor and the drafting committee arrived at language to 
modify his proposed amendment to the Points to Consider. He asked for a motion to 
restore the question for consideration again. Dr. Epstein moved to take the motion from 
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Recombinant DNA Research, Volume 14 
