Recombinant DNA Advisory Committee - 2/10-11/92 
HLA-B7 antigen. Dr. Nabel responded that other cells also incorporate the MHC gene 
and express it. The immune system will respond to these cells, resulting in a beneficial 
effect due to mobilization of the immune system against the tumor. It is possible that the 
local microcirculation could be compromised. Toxicity studies demonstrate that there is no 
gene migration to vital organs resulting in damage. 
Dr. Haselkom asked about evaluating the effects of treatment on multiple metastases. Dr. 
Nabel explained that as many of the tumors would be followed as possible. The protocol 
provides for CT scans of the chest and abdomen so that visual sites can be monitored as 
well. Although one cannot rule out any protective systemic effects of this treatment, 
studies have shown that the treatment will not cause large contralateral tumors to regress. 
The goal of this Phase I trial is to acquire data to aid in the determination of the optimal 
dosage to achieve expression of the recombinant gene. 
Dr. Hirano asked why the patient population is limited to those with an expected survival 
of one year. Dr. Nabel answered that this population was chosen in order to confirm 
expression and ensure safety in a limited population of patients. 
Committee motion 
Dr. R. Murray moved that the protocol be approved including the language change to the 
consent form recommended by Dr. Carmen. Ms. Buc seconded the motion. The motion 
passed by a vote of 13 in favor, 0 opposed, and no abstentions. 
VII. FUTURE ROLE OF THE HUMAN GENE THERAPY SUBCOMMITTEE/AMEND 
POINTS TO CONSIDER/ AMEND NIH GUIDELINES SECTIONS III-A AND IV-C 
Review-Dr. R. Murray and Mr. Mannix 
Dr. R. Murray reported the findings of the Working Group on the Future Role of the 
RAC. The working group was composed of Drs. Childress, B. Murray, Wivel, and himself. 
The working group held a conference call on November 13, 1991, to discuss the future role 
of the HGTS. During the HGTS November 1991 meeting, the working group suggested 
that the HGTS phase out of existence. The human gene therapy transfer proposals will be 
reviewed by the RAC; those members of the HGTS who are not currently members of the 
RAC and who are eligible would become RAC members. To compensate for the 
additional workload, the RAC could possibly hold additional meetings per year. There 
was a discussion about the transition of HGTS members onto the RAC. One option that 
was presented was to have the HGTS members become non-voting members or ex officio 
members, allowing immediate participation with the RAC. As RAC members' terms were 
completed, the HGTS members could assume full member status. A plan for phasing out 
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Recombinant DNA Research, Volume 15 
