Recombinant DNA Advisory Committee - 09/9-10/93 
III-A CHAIR REPORT ON RAC-APPROVED HUMAN GENE TRANSFER 
PROTOCOLS/DR* WALTERS 
Dr. Walters summarized the human gene transfer protocols that have been approved by 
the RAC to date. Of the 52 protocols approved by the RAC, 46 of these studies (24 
gene therapy and 22 gene marking) have been approved by the NIH Director. Listed 
below is a breakdown of the NIH- and RAC-approved protocols (Attachment II): 
* 18/Cancer 
* 2/Human immunodeficiency virus (HTV) 
* 9/Genetic diseases (5/cystic fibrosis, 1/adenosine deaminase 
deficiency (ADA), 1 /familiar hypercholesterolemia, and 
2/Gaucher disease) 
* 21/Others 
III-B. CHAIR REPORT ON MINOR MODIFICATIONS TO NIH-APPROVED HUMAN 
GENE TRANSFER PROTOCOLS/DR. WALTERS 
Dr. Walters stated that a total of 18 minor modifications have been approved to date. 
He summarized three modifications that were approved since the June 7-8, RAC 
meeting: (1) Dr. James Wilson has been granted permission to transfer his 2 protocols 
from the University of Michigan to the University of Pennsylvania, and (2) Dr. Scott 
Freeman has been granted permission to transfer his protocol from the University of 
Rochester to Tulane University School of Medicine (Attachment HI). 
IV. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
GENE THERAPY PROTOCOL ENTITLED: PHASE I STUDY OF TRANSFECTED 
CANCER CELLS EXPRESSING THE INTERLEUKIN-2 GENE PRODUCT IN 
LIMITED STAGE SMALL-CELL LUNG CANCER /DRS. CASSILETH, PODACK, 
SRIDHAR, AND SAVARAJ 
Review-Dr. Miller 
Dr. Walters called on Dr. Miller to present his primary review of the protocol 
resubmitted by Drs. Peter A Cassileth, Eckhard Podack, and Kasi Sridhar of the 
University of Miami, and Dr. Niramol Savaraj of the Miami Veterans Administration 
Hospital, Miami, Florida. This protocol was deferred at the March 1993, RAC meeting 
until the investigators returned to the full RAC with additional data and a revised 
protocol. The intent of this protocol is to culture small-cell lung carcinoma (SCLC) cells 
from patients and infect them with a bovine papilloma virus (BPV) vector expressing the 
gene for interleukin-2 (IL-2). Following lethal irradiation, IU2 producing tumor cells 
will be reimplanted into patients to stimulate proliferation of tumor-specific cytotoxic T- 
lymphocytes (CTL) capable of destroying the reimplanted and established tumors. One 
primary concern of Dr. Miller was whether irradiation will prevent growth of the 
modified tumor cells after injection into patients. This issue is critical because the 
addition of BPV transforming genes into tumor ceils could possibly increase the 
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Recombinant DNA Research, Volume 18 
