Recombinant DNA Advisory Committee - 09/14-15/92 
Dr. Leventhal stated concerns about the eligibility requirement that patients must have 
an anticipated life expectancy of less than six months. It is not ethical to permit a 
patient with such advanced disease to participate in an experimental protocol which 
offers no therapeutic benefit. Also, there has not been a satisfactory response with 
regard to defining criteria for failure versus success. 
Dr. Leventhal stated that she had initial concerns regarding the cost of the certain 
procedures to the patient; however, Dr. Lotze has specified that there will be no cost to 
the patient for additional evaluations. 
Review-Dr. DeLeon 
Dr. DeLeon said that the protocol does not include the details of the clinical assessments 
that will be performed after the vaccine has been administered. Dr. Lotze has provided 
a revised section to the protocol to outline these procedures. Another concern is that in 
a population size of 20 patients with four histological diagnoses, it will be difficult to 
measure therapeutic efficacy. 
Review-Dr. Zallen 
Dr. Zallen stated that the investigators have adequately responded to her questions 
regarding patient recruitment and conduct of the informed consent process. There is a 
section of the informed consent document that is still of some concern regarding the 
requirement that the patient is responsible for costs associated with the thorascopic 
removal of lung metastases. She asked Dr. Lotze to explain why a patient will be 
required to pay for a procedure that is necessary to obtain tumor cells that will be used 
to develop the vaccine. This procedure is part of the experimental process. 
The right-to-withdraw section of the informed consent document should be revised so 
that it is written in the first person singular. All references to the term "therapy" should 
be omitted from the informed consent document since this procedure has not been 
proven to be therapeutic. Several paragraphs had inadvertently been deleted from the 
revised protocol, and this language needs to be reinserted. 
Dr. Zallen asked if there is the possibility that a patient will develop an immune 
response against the autologous fibroblasts. Could insertion of the IL-4 gene result in 
the overproduction of a normal antigen that would elicit such a response. 
Other Comments 
Dr. Haselkom suggested that the word "vaccine" should be removed from the protocol 
since this is an inappropriate term. 
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Recombinant DNA Research, Volume 16 
