Recombinant DNA Advisoiy Committee - 12/2-3/93 
or medical information may be obtained from treating additional patients on a protocol 
that is based on non-definitive data. He recommended disapproval of this protocol. 
Review-Ms. Meyers 
Ms. Meyers said that many of her initial concerns about the Informed Consent document 
have been addressed by the investigators. However, there are several remaining issues 
that should be addressed by the PI. Why are the investigators proposing to use 
cryopreserved, allogeneic cells obtained from the deceased patient? She cited the 
California court decision (John Moore versus the University of California) in which the 
court ruled that any commercial preparation derived from a patient's cells is the property 
of that patient, and the manufacturer must obtain permission for the use of such cells 
and provide compensation. Has written permission been obtained for the use of these 
cells prior to the patient's death? Although a minimum expected survival (3 months) has 
been defined, a maximum expected survival (i.e., 1 year) should be included. The 
Informed Consent document should be revised to include a statement about patient 
confidentiality and protection from the media. She expressed her displeasure about the 
inaccurate press report by Reuters Information Services, Inc., which suggests that the 
single patient trial was efficacious. 
Other Comments 
As a follow-up to Ms. Meyers comments and regarding the inaccuracy of the Reuters 
press report about the single patient trial, Dr. Haselkom asked the investigators about 
two quotations: (1) "the patient lived several months longer than the average life 
expectancy of a person suffering with the particular form of incurable brain cancer," and 
(2) "the fact that we were able to demonstrate an immune response against the tumor 
suggests additional evaluation of patients is warranted." Dr. Leventhal expressed her 
objection to the statements made in the Reuters news report. The patient treated on the 
single patient trial received Decadron, Tamoxifen, and other forms of antitumor therapy. 
It is impossible to draw any scientific conclusions about the effects of the gene transfer. 
Dr. Leventhal disagreed with the investigators' interpretation of the immunological data 
obtained from the single patient. The preliminary data does not support approval of this 
proposal. 
Dr. Walters called on Dr. Parkman to interpret the immunological data obtained from 
the previous patient. Dr. Parkman stated that the investigators used an in vitro system to 
evaluate the cytolytic capacity of peripheral blood lymphocytes. The data derived from 
these in vitro experiments demonstrates a slight increase in cytolytic activity in response 
to this treatment. 
Investigator Response-Dr. Sobol 
In response to Ms. Meyers' concern that an autopsy was not obtained on the single 
patient who died while on the previous trial, Dr. Sobol explained that the family denied 
the request for autopsy. However, in vitro experiments were performed with cells 
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