Human Gene Therapy Subcommittee - July 29-30, 1991 
would be straightforward to measure the tumor mass at the injection site on a regular 
basis, along with other measurable lesions. If they are unmeasurable, the appropriate 
scans could be performed biweekly to compare the growth rates. 
Dr. Neiman said that all of the possible toxicides cannot be known, and that it is in the 
best interest of the investigators and the institution to have a pilot study performed. 
Dr. D. Miller said that PCR analysis should be performed on any tumor tissue removed 
from the patients after treatment to determine if gene-modified cells have metastasized 
to new sites. 
Dr. Leventhal added that she would like a preliminary report after five patients with 
any of the three cell types of cancer previously described. The HGTS would need to 
know the rate of gene-modified tumor cell growth, the rate of cytokine production, the 
spread to other sites, the generation of cytolytic cells, and how these procedures affect 
the resident tumor growth rate. She reiterated that she would like additional nude 
mouse experiments with modified and unmodified tumor cell lines. 
Dr. Parkman added that he does not see the need for controlled experiments in which 
patients would receive unmodified cells. 
Dr. Wivel restated the motion to approve the protocols with the following stipulations. 
Only gene-modified cells are to be used in these protocols. The investigator is 
requested: (1) to report his results after the first five patients have been studied in the 
three histological types of tumor; (2) to measure the rate of cell growth at the injection 
site; and (3) to perform a PCR assay for cytokine DNA on the inguinal lymph nodes 
and in tumor biopsies from other sites in the body. 
Dr. Walters put the motion to provisionally approve both protocols to a vote. The 
motion passed by a vote of 12 in favor, 0 opposed, and no abstentions. 
VIII. FUTURE MEETING DATES OF THE HUMAN GENE THERAPY SUBCOMMITTEE 
AND THE RECOMBINANT DNA ADVISORY COMMITTEE 
Dr. Walters noted that the next meeting of the HGTS will be November 21-22, 1991. 
The next RAC meeting will be October 7-8, 1991. 
Recombinant DNA Research, Volume 14 
[917] 
