criticized by some because it can recombine with helper virus and 
become infectious. Dr. Dusty Miller has developed PA317/LNL6 clone 
8, which is still N2 but has had a gag start gene changed to a stop 
making recombination less likely. This line is being grown in 
Dr. Anderson's lab for future applications. The Bank line would 
be suitable also but cannot be used in humans , at the 
investigators' request. Other systems are also under investigation 
but will not be ready for some time. Approval was requested for 
N2 because the investigators felt that it was preferable to obtain 
broad approval that would permit adoption of better, safer vectors 
as they were developed, without having to go through the same 
review process for each one. 
Dr. Blaese 
Dr. Blaese discussed the issue of G418 selection, noting that it 
was done originally in order to characterize the effects of 
marking, but was not necessary for the protocol. He believes that 
multiple transductions will allow satisfactory marking and a small 
aliquot of marked TIL can be retained for research and analysis 
purposes . 
Dr. Parkman moved that permission be given to initiate the protocol 
given the following conditions: 
1. 10 patients, 
2. The patients have life expectancy of about 90 days, 
3. Patients give informed consent, and 
4. Investigators provide additional data before expanding 
the trial by adding patients or inserting a gene for 
therapeutic purposes. 
Dr. Childress seconded the motion. 
In view of the fact that there are still details of the protocol 
to be worked out, Mr. Capron asked who would give final approval. 
Dr. Neiman noted that in any clinical protocol, some freedom is 
given to make minor modifications without violating any 
understanding. Dr. Parkman added that certain parameters for this 
protocol are considered essential to this protocol, but may not be 
appropriate for another. 
Dr. Murray noted that at his institution, the Institutional Review 
Board defines key factors in any protocol, and then the 
administrator determines the other variables. He emphasized that 
a clear statement must accompany this motion that approval does 
not constitute precedent for future experiments in gene therapy, 
particularly with respect to animal models. This statement was 
accepted as an amendment to the motion. 
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Recombinant DNA Research, Volume 13 
