Recombinant DNA Advisory Committee - 10/7-8/91 
Dr. Leventhal said she would prefer to see the experiments done with whole cells before 
there is an elaborate effort made to fractionate the active principle. 
Dr. Mclvor proposed that the investigators examine the lymphocytes of the mice that 
have been treated to compare the levels of their cytotoxicity against the specific tumor 
target. This will help address the question of whether stimulation of an immune 
response is part of the mechanism. With respect to the prolonged survival curves, he 
questioned what ratio must be attained to save these animals and is it safe. 
Dr. Geiduschek suggested that it might be possible to convey specific concerns about the 
protocol without having to discuss them around the table. He said he would be willing 
to convey them to Dr. Freeman and his coworkers directly. 
Mr. Capron thought that the investigators were owed an explanation of what points are 
leading the committee to vote for a deferral. He said that the consent form needs to 
state that this is a study and not a vaccine treatment. The term vaccine is confusing to 
the ordinary person. It is a Phase I study of a biologic. In any case, the primary benefit 
to science is to determine its safety and to obtain a dose-response. 
Dr. McGarrity put the motion to a vote. The motion was to defer this proposal until Dr. 
Freeman and his colleagues supply the requested information. The motion passed 
unanimously by a vote of 19 in favor, 0 opposed, and no abstentions. 
IV. PROPOSED AMENDMENTS TO APPENDIX D OF THE NIH GUIDELINES 
REGARDING HUMAN GENE THERAPY PROTOCOLS ENTITLED: 
IMMUNIZATION OF CANCER PATIENTS USING AUTOLOGOUS CANCER 
CELLS MODIFIED BY INSERTION OF THE GENE FOR TUMOR 
NECROSIS FACTOR AND IMMUNIZATION OF CANCER PATIENTS 
USING AUTOLOGOUS CANCER CELLS MODIFIED BY INSERTION 
OF THE GENE FOR INTERLEUKIN-2 
Dr. McGarrity announced he would disqualify himself from the review of these protocols. 
Recently, he has accepted employment from Genetic Therapy, Inc. (GTI). He noted 
that he had taken the position since the last HGTS meeting. While GTI is not 
mentioned in these protocols, Dr. Rosenberg has used vectors from them in the past. 
He turned the proceedings over to Dr. B. Murray. 
Dr. B. Murray said there are two items that are relevant to this protocol: (1) In the 
original proposal, the NIH Institutional Biosafety Committee (IBC) requested additional 
studies using autologous cells lacking either the tumor necrosis factor (TNF) or the 
interleukin-2 (IL-2) genes. The NIH IBC has rescinded that request and has given 
formal approval to this protocol. (2) FDA approval has been granted for this protocol. 
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Recombinant DNA Research, Volume 15 
