Recombinant DNA Advisory Committee - 6/9-10/94 
will be used. Preclinical animal data and data from the single patient entered on the 
previous study indicate the possible efficacy of this approach. Since their previous 
submission, the investigators have documented the dose of irradiation required for 
complete tumor cell killing and that this dose allows continued IL-2 production for at 
least 2 weeks. The protocol is well written and has been approved by both the local IRB 
and the IBC. Potential danger to patients or other individuals from a recombinant DNA 
standpoint is low. Dr. Miller recommended approval of the protocol. 
RevieW“Dr. Straus (presented by Dr. Wivel) 
Dr. Wivel summarized Dr. Straus' written comments. Dr. Straus stated that the protocol 
is not fundamentally changed from the prior submission. This resubmission addresses 
most of the concerns raised by the RAC members during the previous review. However, 
the investigators have failed to address the issue of the necessity for the two study arms, 
i.e., autologous and allogeneic tumor cells. The use of allogeneic cells is not 
scientifically validated; therefore, the investigators have agreed to delete the allogeneic 
arm of the study in their written response to the primary review. Dr. Straus 
recommended approval of the protocol based on deletion of the allogeneic tumor cell 
arm of the study. 
Review-Ms. Meyers (presented by Dr. Walters) 
Dr. Walters summarized the written comments submitted by Ms. Meyers. Ms. Meyers 
questioned the use of a cell line derived from the deceased glioblastoma patient. 
However, the investigators have since agreed to delete the allogeneic tumor cell arm of 
the study. Ms. Meyers expressed concern about the use of immunotherapy for the 
treatment of brain tumors. The assumption that intracranial tumors can be cured by 
immunotherapy is based on an article published in 1983. Adoptive immunotherapy has 
not led to any major therapeutic breakthroughs for cancer treatment. 
Investigator Response-Dr. Sobol 
Dr. Sobol stated that based on Dr. Straus' and Ms. Meyers' comments, the trial will only 
involve autologous cells. ID-2 transduced cells will be compared to nontransduced cells. 
Dr. Sobol agreed to the reviewer's suggestion that both transduced and nontransduced 
cells should receive identical doses of irradiation. The highest dose of irradiation will be 
used that does not interfere with ID2 production. 
Committee Motion 
The RAC approved a motion made by Dr. Miller and seconded by Dr. Post to accept the 
protocol (with deletion of the allogeneic cell study arm) submitted by Drs. Robert Sobol 
and Ivor Royston of the San Diego Regional Cancer Center, San Diego, California, by a 
vote of 13 in favor, 0 opposed, and no abstentions. 
XVII. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
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