Recombinant DNA Advisory Committee - 7/31/90 
Factor That Can Be Administered to Patients with Advanced 
Cancer." Further, the form contains many references to 
"treatments." A scientifically naive person would sign this form 
thinking that the purpose of the study is to treat his or her 
cancer. 
Dr. Rosenberg said he tried to incorporate the sense of what was 
discussed in the HGTS, and he was willing to make additional 
changes. He did add a sentence in the second paragraph of the 
form to illustrate that the purpose of the study was to determine 
the maximum tolerable dose of the TIL^j^p, and it is not 
predictable at this time whether the insertion of the gene will 
have any benefit to the patient. Furthermore, the patients are 
currently getting a treatment (IL-2 administration) which has 
been used for almost two and a half years and which has benefited 
some patients. The addition of the gene insertion was intended 
to be seen as the portion of the treatment for which it was 
impossible, at this time, to predict benefit to the patient. 
Dr. Parkman said that the patients were receiving two treatments 
(IL-2 therapy and TIL therapy) in one, and that one way to 
address this would be to have them sign separate consent forms. 
He said the issue of toxicity is not spelled out in the consent 
form, as well as options for therapies that may have to be 
instituted to reverse the toxicity if it occurs. Since this 
protocol is going to result in toxicity in some patients in order 
to find the maximum tolerated dose, the side effects of TNF 
toxicity should be pointed out, and a separate consent form 
should be signed. 
Dr. Walters said he supported Dr. Parkman 's comments. He thought 
the choice should be made clear to patients as to whether to 
continue with an existing and apparently successful protocol or 
to consent to participation in a Phase I study with tumor 
necrosis factor. 
Dr. Miller said that while he agreed with Dr. Parkman 's 
presentation, it did not seem correct to subject the patients to 
signing two consent forms because this study is indeed separate 
from the standard TIL cell therapy. To include a TIL cell 
therapy consent form and a TIL,jjgp therapy consent form is not 
appropriate. 
Dr. B. Murray asked if patients who did not elect to enter the 
TILjjjp protocol would still be eligible for IL-2/TIL cell 
therapy. Dr. Rosenberg said that was correct, and that there are 
a larger number of patients with advanced melanoma seeking care 
than can possibly be treated. Patients who do not elect to enter 
the protocol would be offered a different protocol. Dr. B. 
Murray said she agreed with Dr. Epstein that the consent form 
Recombinant DNA Research, Volume 14 
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