Recombinant DNA Advisory Committee - 7/31/90 
enough patients, who would fulfill the inclusion criteria over 
the next 3-4 years, to accumulate the patient numbers necessary 
for the study. 
Dr. Mclvor asked Dr. Parkman if he felt the withdrawal of PEG-ADA 
or immunoglobulin was a "minor" modification to the protocol. 
Dr. Parkman said he did not think so. 
Dr. Gellert moved that the protocol be approved. Dr. Childress 
seconded the motion. Dr. Wivel asked for clarification on the 
issue of intraperitoneal administration. He said the motion of 
the HGTS for approval of the protocol included a proviso that 
intraperitoneal (I.P.) administration not be carried out at this 
time. Dr. McGarrity asked Dr. Mclvor if this was also included 
in his question as to what constituted a minor change in the 
protocol. Dr. Mclvor said he was only referring to withdrawal of 
PEG-ADA or immunoglobulin treatment. Dr. Parkman said he 
remembered specifically that the HGTS had agreed that the 
investigators could choose to ask that the introduction of I.P. 
administration be viewed as a minor modification. However, the 
HGTS did not want to prejudge the outcome of such an application 
and left this up to the Chair of the RAC to decide whether he 
felt this would be a minor modification, dependent upon the 
information supplied as part of any such application. 
Dr. McGarrity also noted that the current protocol, as approved, 
called for 10 patients to be treated and asked if an increase 
above this number should be viewed as a minor modification. Dr. 
Parkman said it would depend upon the results in those 10 
patients. Dr. McGarrity said this could be taken up at a later 
date. 
There being no further discussion. Dr. McGarrity put the motion 
to approve the protocol to a vote. The motion passed by a vote 
of 16 in favor, 1 opposed, and zero abstentions. 
Proposed Addition to Appendix D of the ”NIH Guidelines" 
regarding HTiman Gene Therapy Protocol entitled ”Gene Therapy of 
Patients with Advanced Cancer using Tumor Infiltrating 
Lymphocytes Transduced with the Gene Coding for Tumor Necrosis 
Factor (TNF)”; 
Dr. McGarrity called on Dr. Mclvor to begin the discussion of 
this protocol. Dr. Mclvor said he presented a lengthy review at 
the HGTS meeting, and he would summarize the major points of this 
review for members of the RAC who were not present at that 
meeting. 
Dr. Mclvor said the proposal presented some new challenges in 
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