Recombinant DNA Advisory Committee - 06/1-2/92 
transfer. Even in Dr. Oldfield's protocol, where cells will be administered, there is still 
gene insertion involved. 
Dr. Haselkom asked Mr. Capron what the purpose of categorization would be and if he 
anticipated administrative differences in the review of certain protocols? Mr. Capron 
stated that Dr. Walters provided an initial categorization of gene transfer versus therapy 
protocols as Chair of the HGTS. Mr. Capron stated that he would like to expand these 
two categories to include cellular approaches versus true gene therapy. 
Dr. Kelley suggested that the RAC should not belabor nomenclature at this time. All of 
these protocols come within the purview of the RAC, and this issue is all that needs to 
be considered. Dr. Murray noted Mr. Capron's proposal is a starting point for the RAC 
to consider issues that may arise in the future as increasing numbers of protocols are 
reviewed and approved. 
Dr. Murray ended the first day's session. 
X. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
TWO HUMAN GENE THERAPY PROTOCOLS ENTITLED: IMMUNIZATION WITH 
HLA-A2 MATCHED ALLOGENEIC MELANOMA CELLS THAT SECRETE 
INTERLEUKIN-2 (IL-2) INPATIENTS WITH METASTATIC MELANOMA AND (2) 
IMMUNIZATION WITH IL-2 SECRETING ALLOGENEIC HLA-A2 MATCHED 
RENAL CELL CARCINOMA CELLS INPATIENTS WITH ADVANCED RENAL 
CELL CARCINOMA /DR. GANSBACHER: 
Metastatic Melanoma Protocol 
Review-Dr. Kelley 
On June 2, 1992, Dr. Murray reconvened the RAC meeting. She called on Dr. Kelley to 
present his reviews. Dr. Kelley presented an overview of the two protocols submitted by 
Dr. Bemd Gansbacher of Memorial Sloan-Kettering Cancer Center, New York, New 
York. Dr. Kelley described the first protocol as a pilot study of the immunization with 
human leukocyte antigen (HLA)-A2 matched allogeneic melanoma cells that secrete 
IL-2 in patients with metastatic melanoma. The objective of the protocol is to evaluate 
an allogeneic melanoma vaccine that has been transduced with a retroviral vector 
containing a gene coding for IL-2. The investigators will attempt to determine the 
toxicity of this vaccine preparation, its anti-tumor activity, and evaluate the induction of 
humoral and/or cellular immunity in patients with metastatic melanoma. 
Dr. Kelley said that the protocol was based on in vivo data in which tumor bearing 
animals were treated with cytokine transduced tumor cells that resulted in local secretion 
Recombinant DNA Research, Volume 15 
[709] 
