Recombinant DNA Advisory Committee - 06/7-8/93 
line to be used for the human study, should be provided prior to approval of this 
protocol. 
Review— Dr. Dronamraju 
Dr. Dronamraju noted that the patient population is divided into several categories 
according to their ethnic background and gender. What is the scientific rationale for 
excluding certain ethnic groups? 
Other Comments 
Mr. Capron stated that the Informed Consent document does not include a 
recommendation for male/female contraception, a description of the financial 
responsibility of patients, or a request for autopsy. Is this study a gene therapy or gene 
marking protocol? Dr. Walters commented that this immunization study has therapeutic 
intent. Ms. Meyers objected to the use of the word "vaccine" in the Informed Consent 
document and suggested several other minor changes. 
Dr. Geiduschek said that the murine data do not directly correlate with the human 
proposal, e.g., different cell numbers and treatment regimen. Dr. Post asked the PI to 
clarify an earlier statement about RCR assays. Dr. Parkman said that critical data were 
not submitted prior to the meeting; therefore, it is impossible for the RAC to evaluate 
the protocol. 
Investigator Response-Dr. Cohen 
Dr. Cohen presented in vivo murine data demonstrating prolonged survival of mice that 
were immunized with IL-2 secreting allogeneic mouse fibroblasts expressing melanoma 
associated antigens. Dr. Parkman remarked that the murine experiments were 
performed with non-irradiated cells. Dr. Cohen agreed that the cells were not irradiated, 
and that all tumors eventually recurred. Responding to Dr. Smith's question about the 
effect of irradiation. Dr. Cohen presented in vivo murine data demonstrating increased 
survival with irradiated IL-2 cells over control animals; however, survival was less than 
with non-irradiated cells. Dr. Smith noted that the cells used for the animal experiments 
were irradiated with 5,000 rads not 10,000 rads as proposed for the human study. 
Experiments have not been submitted using IL-2 producing cells that have been 
irradiated with 10,000 rads. Responding to Dr. Post's question about RCR assays, Dr. 
Cohen said that these safety assays will be performed by Microbiological Associates, Inc., 
Rockville, Maryland 
Dr. Smith expressed his concern at the lack of in vitro human data. He said that he is 
inclined to recommend deferral of this protocol until additional data is submitted. Data 
Recombinant DNA Research, Volume 17 
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