Recombinant DNA Advisory Committee - 09/9-10/93 
3 out of 6 alleles from the melanoma cell line at the Class 1 major histocompatibility 
locus. The transduced cells will be lethally irradiated with 5,000 rads. The major 
endpoint of the study will be toxicity. Other minor endpoints include measurement of 
induction of B and T cell responses to tumor cells and any potential clinical anti-tumor 
effect. The investigators have addressed most of the previous concerns raised by the 
RAC. Additional data on the irradiation of the tumor cells and production of 11^2 have 
been provided. Further information has been provided regarding the efficacy of the 
therapy in the murine model. The Informed Consent document has been revised and 
addresses the issue of financial responsibility for research expenses and routine care. 
Results for detection of RCR have been provided. Dr. Smith recommended approval of 
the present protocol. 
Review-Ms. Buc 
Ms. Buc commented primarily on the Informed Consent document. She suggested 
several changes to avoid misleading patients that any efficacy will be expected from this 
Phase I toxicity study. She expressed uneasiness about a statement that participation in 
the study may be halted at the sole discretion of the PI should contraception be 
interrupted. 
Other Comments 
Ms. Meyers raised several questions in her written comments about financial 
responsibility and patient privacy that have been addressed by the investigators. Dr. 
Haselkom's written comments requested identification of the investigator who will be 
responsible for conducting the clinical study since Dr. Richards, a co-investigator on the 
protocol, is no longer employed by the University of Chicago. 
Dr. Miller asked about the adequacy of the experiment to test viability of the cells after 
irradiation. The number of cells tested were far below that to be administered to 
patients. He questioned adequacy of the RCR assays for detecting viruses that might be 
activated in the irradiated human cells. 
Dr. Walters raised several concerns about the Informed Consent document. The request 
for post-mortem should not be stated as if agreement to this procedure is a condition for 
entering this study. The Purpose of the Research Study section should begin with a 
sentence that informs patients that this protocol is a toxicity study, and that no 
therapeutic benefit is expected. 
Ms. Buc remarked that under the Uniform Anatomical Gift Act, patients have the right 
to agree to donate organs or tissues for medical studies. A lengthy discussion ensued 
regarding'whether families can override the patient's wishes. Mr. Capron stated that a 
patient can legally donate his/her body for a scientific study over the objection of family 
members under the Uniform Anatomical Gift Act. Dr. Chase suggested that a joint 
Informed Consent process in which patient's assent and the relatives' intent for autopsy 
could be obtained simultaneously and would avoid later discord on this matter. 
Recombinant DNA Research, Volume 18 
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