Recombinant DNA Advisory Committee - 06/1-2/92 
autologous SK-RC-28 cells generated an autoimmune response in the patient from which 
this cell line was derived. No evidence of an autoimmune response has been observed in 
the melanoma setting in which patients received the allogeneic vaccines. 
Dr. Kelley asked if the measures of immune activity can be improved? Dr. Gansbacher 
replied that renal cell carcinoma cell line expresses GP120, GP140, and GP160 antigens. 
Antibody response to these antigens should be measurable. Dr. Gansbacher stated that 
CD4 mediated antibody response against well defined differentiation antigens is 
extremely rare. 
Mr. Barton asked Dr. Gansbacher to clarify exactly what the patient will be told about 
alternative treatments since ID2 has recently been approved for use in patients with 
renal cell carcinoma. Dr. Gansbacher stated that the patients who are presented with 
this protocol have already been presented with a variety of alternative protocols, that 
they have already failed. There are other protocols that exclude patients who have 
received alternative treatments. Consequently, some patients could be excluded from 
other protocols and still be eligible for this study. 
Committee Motion 
Dr. Kelley moved to approve the protocol. The motion was seconded by Dr. Bourquin. 
The motion to approve the renal cell carcinoma protocol is contingent on the stipulation 
that a revised statement be included in the informed consent document regarding the 
description of the retroviral vector. The motion passed by a vote of 20 in favor, 0 
opposed, and no abstentions. 
XI. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
HUMAN GENE TRANSFER PROTOCOLS ENTITLED (1) GENETIC MARKING 
WITH RETROVIRAL VECTORS TO STUDY THE BIOLOGY OF HEMATOPOIETIC 
RECONSTITUTION AFTER AUTOLOGOUS TRANSPLANTATION FOR MULTIPLE 
MYELOMA , (2) GENETIC MARKING WITH RETROVIRAL VECTORS TO STUDY 
THE BIOLOGY OF HEMATOPOIETIC RECONSTITUTION AFTER AUTOLOGOUS 
TRANSPLANTATION FOR BREAST CANCER, AND (3) GENETIC MARKING WITH 
RETROVIRAL VECTORS TO STUDY THE BIOLOGY OF HEMATOPOIETIC 
RECONSTITUTION AFTER AUTOLOGOUS TRANSPLANTATION FOR CHRONIC 
MYELOGENOUS LEUKEMIA /DR. DUNBAR: 
Review-Dr. Geiduschek 
Dr. Murray called on Dr. Geiduschek to present his review. Dr. Geiduschek presented 
an overview of the three protocols submitted by Dr. Cynthia Dunbar of the NIH, 
Bethesda, Maryland. Dr. Geiduschek stated that this study is a combination of three 
Recombinant DNA Research, Volume 15 
[717] 
