Human Gene Therapy Subcommittee - 11/21-22/91 
describe in detail the clinical observations seen in patients that had previously been 
treated with this same protocol without the gene marking portion. The investigators 
need to respond to previous concerns of the UCLA IRB, regarding the procedural 
aspects of monitoring six separate categories in this protocol. The IRB asked that the 
investigators use precautions comparable to those used for blood banking. The IRB has 
a legitimate concern considering the complexity of the protocol. 
Dr. Mclvor commented on the issue of molecular tagging of lymphocytes to demonstrate 
specific homing to target tissues rather than the random presence of lymphocytes in 
tumors as a result of circulation through the vascular system. This protocol has more 
emphasis on quantitating PCR products than other protocols previously reviewed by the 
HGTS. The investigators need to further explain the use of a control system to 
quantitate the number of tagged lymphocytes in target tumors compared with the 
number of tagged lymphocytes in control tissues. How would this system demonstrate 
specific homing to tumor cells? 
Ms. Meyers stated that the informed consent document is too technical for the lay 
person to understand. Several sections require clarification. Dr. Walters referred Ms. 
Meyers to an amended version of the consent form that contains most of the issues that 
she addressed. 
Mr. Capron stated that there were several ambiguities in the consent form. In one 
section, the document informs the patient that TIL therapy will be expected to "cause 
partial or complete regression of their tumor." In another section, TIL therapy is 
describe more tentatively as to whether or not the patient will benefit. Yet in another 
area of the consent form that addresses gene marking, the investigators state that 
"marked TIL and PBL may be of benefit to patients on future protocols, but this 
research will not be of immediate benefit to patients entering this trial." The 
investigators need to be consistent in describing benefit of the procedure to the patient. 
Mr. Capron expressed concern about the title of the research, "Treatment of Patients With 
Metastatic Melanoma and Renal Cell Cancer ." The title should be divided as well as the 
protocols so that people being treated for one particular type of cancer would not be 
misled to think that they may have another type of tumor. Clear separation of the 
consent forms would avoid unnecessary confusion to the patient. Mr. Capron agreed 
with Ms. Meyers that more "patient friendly" language should be incorporated into the 
document. 
Dr. Leventhal said that perhaps the HGTS was spending too much time discussing 
changes in the informed consent document that might not be accepted by the 
investigator's IRB. Since the IRBs are the final arbiters of this document, perhaps the 
HGTS should limit their review to the gene marking portion of the consent form. The 
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