Human Gene Therapy Subcommittee - 11/30/90 
answer. Dr. Parkman added that a PCR from Dr. Rosenberg comparing normal skin 
to tumor with IL-2 would assist the reviewers. Dr. Lxitze said he would ask Dr. 
Rosenberg for this data. 
Dr. Erickson seconded Dr. Epstein's motion. 
Mr. Capron offered a friendly amendment to include the other points raised in 
regard to the consent form. Dr. Epstein accepted this friendly amendment as part of 
the motion. 
Mr. Capron asked if there was a requirement for the investigators to present data 
from Dr. Rosenberg on PCR comparing normal skin to tumor. Dr. Epstein said it is 
improper to ask the investigator to present someone else's data. Dr. Parkman noted 
that Dr. Rosenberg has worked closely with both the HGTS and Dr. Lotze, and Dr. 
Rosenberg's data should not be a prerequisite, but that the protocol design should 
incorporate this information prospectively. 
Dr. Lotze said that one problem relating to persistence is that many patients have 
TILs present for some time at tumor sites but the TILs tends to disappear from the 
peripheral circulation for long periods of time. Dr. Parkman said that having 
negative peripheral blood for an extended period while continuing to have positive 
signals in tumor might be the clearest demonstration of homing. 
Dr. Walters asked if the sense of the motion was that the additional information will 
be forwarded directly to the RAC rather than the HGTS. Dr. Epstein said a 
schedule should be worked out whereby the primary and secondary reviewers could 
examine the material before the RAC meeting to ensure that it is complete before 
going before the RAC. Dr. Walters suggested that the protocol be submitted to the 
RAC via Drs. Parkman, R. Murray, and Ms. Areen. 
There being no further discussion. Dr. Walters put the motion to a vote. The 
motion passed unanimously by a vote of 11 in favor, 0 opposed, and no abstentions. 
VIII. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES 
REGARDING HUMAN GENE TRANSFER PROTOCOL ENTITLED 
AUTOLOGOUS BONE MARROW TRANSPLANT FOR CHILDREN WITH ACUTE 
MYELOGENOUS LEUKEMIA (AML) IN FIRST COMPLETE REMISSION: USE 
OF MARKER GENES TO INVESTIGATE THE BIOLOGY OF BONE MARROW 
RECONSTITUTION AND THE MECHANISM OF RELAPSE 
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