Recombinant DNA Advisory Committee - 09/9-10/93 
research, public review by the RAC is very important 
Dr. Par km an said that the RAC review of individual protocols is essential to the 
development of science policy concerning gene therapy. Dr. Walters commented that the 
first cystic fibrosis (CF) protocol reviewed by the RAC in December 1992 is an example 
that illustrates the importance of public deliberation by the RAC. Not only did the RAC 
consider a new disease for the first time, but also a new vector (adenovirus). The public 
discussion of the CF protocols was very productive and useful in establishing policy for 
the review of other protocols. 
There was a lengthy discussion about the interpretation of the Footnote 21 of the NIH 
Guidelines in regard to the types of vaccine protocols that are considered exempt. Dr. 
Merchant stated that although submission of protocols for RAC review is on a voluntary 
basis for commercial industry not associated with NIH-funded investigators, it is not 
realistic to conduct serious commercial development efforts without engaging NIH- 
funded investigators or institutions. For commercial research development, the time 
required to complete the review process is critical in order to bring the product to 
market. An exempt or accelerated review process would facilitate the process. 
Dr. Walters requested that Drs. Parkman, Post, Carmen, and Straus form a Working 
Group on Categories for Accelerated Review to report back later on in the meeting. 
The RAC tabled their discussion until the next day to allow the working group to 
develop a revised list of possible categories of accelerated review protocols. 
X. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
GENE THERAPY PROTOCOL ENTITLED: PILOT STUDY OF TOXICITY OF 
IMMUNIZATION OF PATIENTS WITH UNRESECTABLE MELANOMA WITH 
INTERLEUKIN-2 SECRETING ALLOGENEIC HUMAN MELANOMA CELLS I 
DRS. DAS GUPTA AND COHEN 
Review-Dr. Smith 
Dr. Walters called on Dr. Smith to present his primary review of the protocol 
resubmitted by Drs. Tapas K. Das Gupta and Edward P. Cohen of the University of 
Illinois College of Medicine. This protocol was deferred at the June 1993 RAC meeting 
until the investigators could return to the full RAC with the following: (1) data 
demonstrating the efficiency of transduction in Mel-4 cells; (2) data demonstrating 
viability, IL-2 production, and in vivo effect of irradiated transduced cells (either 5,000 or 
10,000 rads) in the murine model; (3) rationale for ethnic eligibility criteria; (4) complete 
responses to the Points to Consider, and (5) RCR testing data demonstrating safety of the 
vector preparation. 
Dr. Smith stated that this study is a Phase I trial using a well characterized human 
melanoma cell line that is transduced with the human IL-2 gene as an immunogenic 
vaccine. Twelve patients with advanced stage melanoma will be accrued on the study. 
The IL-2 secreting melanoma cells will be administered to patients who differ in at least 
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Recombinant DNA Research, Volume 18 
