Recombinant DNA Advisory Committee - 12/2-3/93 
out from ORDA. Dr. Chase recommended that the RAC take stronger action 
concerning the issue of research injury compensation. Dr. Zallen remarked that the 
Informed Consent review should be part of the protocol approval process and agreed 
that a letter should be sent to the IRB as a contingency for approval. 
Dr. Parkman remarked that if the present treatment has no benefit to the patients, the 
statement on compensation for treatment intended to benefit is not operative. Dr. 
Merchant agreed to include a statement in the Informed Consent to indicate that the 
present treatment has no known or expected benefit to patients. 
Committee Motion 
A motion was made by Dr. Straus and seconded by Ms. Meyers to approve the protocol 
with the contingency that the primary reviewers review and approve the following: (1) a 
revised Informed Consent document which includes changes suggested by the RAC and 
includes the Participant Information brochure as an Appendix; (2) the Informed Consent 
document should be revised to include the statement, "This treatment has no known 
benefit, and there is no expectation that there will be any benefit to you," and (3) a letter 
should be sent to the IRB of the University of California at San Diego by ORDA 
requesting the following paragraph be deleted from the Informed Consent document: 
"If I am injured as a result of participation in this research, the University of 
California will provide any medical care I need to treat those injuries - except 
when they are a consequence of research procedures designed to benefit me 
directly. The University will not provide any other form of compensation to me if 
I am injured." 
The motion to approve the protocol passed by a vote of 15 in favor, 1 opposed, and 2 
abstentions. 
XIV. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
GENE TRANSFER PROTOCOL ENTITLED: A PHASE I TRIAL OF B7- 
TRANSFECTED LETHALLY IRRADIATED ALLOGENEIC MELANOMA CELL 
LINES TO INDUCE CELL-MEDIATED IMMUNITY AGAINST TUMOR-ASSOCIATED 
ANTIGENS PRESENTED BY HLA-A2 OR HLA-A1 IN PATIENTS WITH STAGE IV 
MELANOMA /DR. SZNOL 
Review-Dr. Parkman 
Dr. Walters called on Dr. Parkman to present his primary review of the protocol 
submitted by Dr. Mario Sznol of the NTH, Frederick, Maryland. Dr. Parkman explained 
that the investigators propose to enhance the immunogenicity of tumor cells by 
introducing the B7 gene into tumor cells lacking this antigen. Two signals are required 
to induce CTL activity. One signal is initiated when the melanoma antigen binds to the 
T cell receptor. The second signal originates from the binding of the B7 antigen to the 
CD28 receptor of T cells. Melanoma cells are resistant to CTL killing because these 
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Recombinant DNA Research, Volume 18 
