Recombinant DNA Advisory Committee - 6/9-10/94 
II. CHAIR REPORT ON MINOR MODIFICATIONS TO NIH-APPROVED HUMAN 
GENE TRANSFER PROTOCOLS/DR. WALTERS 
Dr. Walters stated that minor modifications were approved to the following human gene 
transfer protocols since the March 3-4, 1994, RAC meeting (Attachment II): 
3/23/94 
Protocol #9309-053 
Investigators: Peter Cassileth/Eckhard Podack 
3/23/94 
Protocol #9206-023 
Investigator Cynthia Dunbar 
3/23/94 
Protocol #9206-025 
Investigator. Cynthia Dunbar 
4/11/94 
Protocol #9212-034 
Investigator Ronald Crystal 
4/13/94 
Protocol #9303-041 
Investigators: Robert Wilmott/Jeffrey Whitsett/Bruce Trapnell 
6/01/94 
Protocol #9209-020 
Investigator Robert Walker 
III. MARCH 3-4, 1994, RAC MINUTES 
The RAC approved a motion made by Dr. Chase and seconded by Dr. Doi to accept the 
March 3-4, 1994, RAC minutes with the inclusion of minor changes suggested by Dr. 
Chase by a vote of 15 in favor, 0 opposed, and no abstentions. 
IV-A. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
GENE TRANSFER PROTOCOL ENTITLED: PHASE I TRIAL OF A 
POLYNUCLEOTIDE AUGMENTED ANTITUMOR IMMUNIZATION TO HUMAN 
CARCINOEMBRYONIC ANTIGEN IN PATIENTS WITH METASTATIC 
COLORECTAL CANCER/DR, CURIEL 
Review— Dr. Haselkorn 
Dr. Walters called on Dr. Haselkorn to present his primary review of the protocol 
submitted by Dr. David Curiel of the University of Alabama, Birmingham, Alabama. Dr. 
Haselkorn explained that the objective of this Phase I study is to determine whether 
intramuscular injection of plasmid DNA containing the cDNA for carcinoembryonic 
antigen (CEA) induces an immune response (humoral or cellular) to CEA in patients 
with advanced colon carcinoma. CEA is an antigen that is present on the surface of 
embryonic cells in normal individuals. The immune response that recognizes CEA as a 
foreign antigen is deleted in early development. However, CEA frequently reappears in 
certain tumors such as colon carcinoma. The rationale of this study is to immunize 
cancer patients with the CEA antigen to overcome the immune tolerance and to induce 
immune response against cancer cells expressing the CEA antigen. 
The materials submitted by Dr. Curiel reference an ongoing study conducted by Dr. 
Jeffrey Schlom of the National Cancer Institute (NCI), NIH. Dr. Schlom's study involves 
the administration of a recombinant vaccinia viral vector encoding CEA in order to elicit 
a CEA-specific immune response in cancer patients. In contrast. Dr. Curiel's study 
involves the administration of a plasmid DNA vector encoding CEA. Dr. Haselkorn 
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Recombinant DNA Research, Volume 19 
