Recombinant DNA Advisory Committee - 7/31/90 
implies they would be getting an efficacious treatment and could 
be viewed as an enticement. 
Dr. McGarrity asked if patients selected for the TNF study would 
necessarily be getting TIL/IL-2. Dr. Rosenberg said it was not 
necessarily the case. 
Dr. Atlas said he thought the protocol bridges both Phase I and 
Phase II clinical studies. He said that each patient is his own 
control. If the patient can reach a maximally tolerated dose, 
the treatment may work for that patient and he suggested telling 
the patient, "You're actually going to go through a treatment. 
If you tolerate the dose that we're trying to achieve, you 
survive long enough, and it works, you have some hope." 
Dr. Miller said this was a simplistic view. In fact, the 
expectation of efficacy is very low, but that this study will 
help elucidate starting dose and frequency of infusion necessary 
to test efficacy. Furthermore, it may only work in a subset of 
patients, and this will be important to know. 
Dr. McGarrity asked whether the consensus of the group was that 
two consent forms were needed or whether separate wording or 
separate paragraphs for the TIL/IL-2 and TIL^jjp was needed. 
Dr. Parkman said the protocol, as written, did not focus enough 
on the issue of potential toxicity, the over-expression of TNF, 
and methods for ameliorating this toxicity should it occur. He 
said it was irrelevant whether this was done in one document or 
two, but that the risks and benefits of both needed to be 
addressed. He said this currently was a good consent document 
for TIL/IL-2, but not for a Phase I study of TNF toxicity. 
Dr. Mulligan said that one solution would be to make a third 
section in the protocol to discuss the TNF with a separate 
heading, similar to the discussion of TIL and IL-2 as found on 
pages 2 and 3 of the consent document. 
Dr. Childress said he had more problems with the wording of the 
first paragraph and suggested that a revised consent form be 
reviewed by two or three members of the RAC. Dr. Rosenberg said 
he wanted to have a consent form that the group felt was 
satisfactory, and he was willing to work with members of the RAC 
to ensure this. 
Dr. McGarrity suggested that Drs. Rosenberg, Walters, Parkman, 
and Epstein confer during the coffee break, bring back to the 
group an outline of topics that would make the committee more 
comfortable, and have the consent form come back before the RAC 
at a future date. 
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Recombinant DNA Research, Volume 14 
