Recombinant DNA Advisory Committee - 09/14-15/92 
significant data is obtained. Dr. Leventhal reminded Dr. Anderson that all of these 
investigators are required to file IRB reports prior to publication. Dr. Leventhal noted 
that published manuscripts do not describe what was proposed in the protocol, only the 
outcome. For example, if an investigator treats more patients that he/she was given 
approval for, then the RAC needs to be apprised of this information. 
Committee Motion 
Dr. Walters moved that the investigators should be required to provide the requested 
information for review prior to the December RAC meeting. Dr. Secundy seconded the 
motion. Dr. Leventhal suggested that protocols should be rescinded if this information is 
not forthcoming. Dr. D. Miller suggested a friendly amendment to the motion that the 
reporting requirements in the Points to Consider should be changed from semi-annual 
reporting to read, "reports not received within 12 months of the initial start date of the 
experiment may result in cancellation of its approval." Dr. Walters noted that to change 
the Points to Consider would required public notice prior to RAC discussion and 
approval as a minor amendment to the NIH Guidelines. Dr. D. Miller withdrew his 
amendment to the motion. 
Dr. Leventhal suggested that a second letter should be sent to investigators of approved 
protocols as a follow-up to the initial request letter dated June 11, 1992. This follow-up 
letter should specify that if the requested information is not received, the approval of the 
protocol will be reconsidered. In addition, the submitted information is due to ORDA 
by November 1, 1992. Drs. Walters and Secundy agreed to accept Dr. Leventhal's 
suggestion as a friendly amendment to his motion. Dr. Murray called for a vote. The 
motion passed by a vote of 20 in favor, 0 opposed, and no abstentions. 
XIII. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
GENE THERAPY PROTOCOL ENTITLED: GENE THERAPY OF CANCER: A 
PILOT STUDY OF IL-4 GENE MODIFIED ANTITUMOR VACCINES t /DR. LOTZE 
Review- Dr. Leventhal 
Dr. Murray called on Dr. Leventhal to present her primary review of the protocol 
submitted by Dr. Michael T. Lotze, University of Pittsburgh, Pittsburgh, Pennsylvania. 
Dr. Leventhal presented a brief overview of the protocol. Systemic IL-4 therapy has 
resulted in no significant antitumor responses as hypothesized. For this reason, the 
investigators propose to administer a mixed vaccine of IL-4 transduced autologous 
fibroblasts and autologous tumor to multiple biopsy sites in order to provide local IL-4 
therapy rather than systemic. The protocol is designed to administer this cell mixture in 
a dose-response manner such that the number of tumor cells is constant and the number 
of fibroblasts will be variable. 
Recombinant DNA Research, Volume 16 
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