Human Gene Therapy Subcommittee - 4/5/91 
termination of the protocol needs to be developed if the relapse rate in the patient 
population exceeds the statistical predictions. The motion passed by a vote of 8 in favor, 
1 opposed, and 1 abstention. 
Dr. Erickson noted that he had also proposed the same motion relative to the second 
protocol. Dr. Kelley offered to second this motion as well. There being no further 
discussion. Dr. Walters put the motion to a vote. The motion passed by a vote of 8 in 
favor, 1 opposed, and no abstentions. 
Dr. Walters then called on Dr. Gellert to present the next agenda item. 
V. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
A HUMAN GENE TRANSFER PROTOCOL ENTITLED: THE ADMINISTRATION OF 
INTERLEUKIN-2 (IL-2), INTERLEUKIN-4 (IL-4) AND TUMOR INFILTRATING 
LYMPHOCYTES TO PATIENTS WITH MELANOMA: 
Dr. Gellert noted that the protocol had been greatly revised to include only one of the 
original five protocols contained in the previous proposal reviewed by the subcommittee. 
Some of the requested data had been supplied, but he noted there were still difficulties 
as to whether the protocol will answer the questions it seeks as its primary aim. He 
noted that his written comments could be found in the written materials along with Dr. 
Lotze's reply, and he summarized his comments for the subcommittee. 
Dr. Gellert noted that the goals of the protocol were two-fold: 
1. To determine whether TILs in selected patients with melanoma grown in 
combinations of IL-2 and IL-4 will lead to objective tumor responses in 
patients receiving it, and 
2. To assess the ability of combinations of IL-2 and IL-4 to cause specific TIL 
localization and persistence at tumor sites using gene-marked TILs. 
Dr. Gellert said that it was dubious whether the second goal could be realized because 
the protocol does not include any experiments in which TIL localization is studied in the 
absence of the lymphokines IL-2 and IL-4; therefore, comparison with a non-lymphokine 
treated group would be impossible. 
Dr. Gellert said that Dr. Lotze had supplied additional information in response to 
stipulations set forth by the subcommittee at its last meeting. A better description of 
how the homing experiments were to be performed was supplied, but it still required 
further clarification with regard to the following; 
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Recombinant DNA Research, Volume 14 
