Recombinant DNA Advisory Committee - 12/2-3/93 
contraception, and request for autopsy. Ms. Meyers asked the investigators to clarify the 
patient's responsibility for any costs related to the treatment. 
Investigator Response-Dr. Kovach 
Dr. John Kovach of the Mayo Clinic, Rochester, Minnesota, said that the major end 
point of this study is any observed change in the titer of anti-B7 CTL activity in the 
peripheral blood. Although the investigators have to resolve certain technical difficulties 
involving assays of biopsy materials, specific cytotoxicity of the untransduced tumor cells 
will be determined. With regard to the Informed Consent document issues, all patients 
will have life long follow-up, and none of the costs of the research will be charged to 
patients. Changes will be made to the Informed Consent document to clarify these 
points. The current statement about research-related injury is derived from other 
protocols previously reviewed by the RAC. A request for autopsy will be included in a 
revised document. 
Dr. Alan Schreiber of Vical, Inc., San Diego, California, clarified the discrepancy of the 
current DNA doses to that of the Nabel protocol. Dr. Schreiber noted Vical's intention 
to initiate this protocol at other sites and encouraged the RAC to adopt an accelerated 
review mechanism for similar trials. Dr. Parkman said that multi-institution studies can 
be encompassed by the current review mechanism if such information is available at the 
time of submission for RAC review. 
Committee Motion 
A motion was made by Dr. DeLeon and seconded by Dr. Doi to approve the protocol 
with the stipulation that a revised Informed Consent document, including the changes 
suggested by the RAC, be reviewed and approved by the primary reviewers. The motion 
to approve the protocol passed by a vote of 18 in favor, 0 opposed, and no abstentions. 
XVI. UPDATE ON DR. ROTH'S PROTOCOL ENTITLED: CLINICAL PROTOCOL FOR 
MODIFICATION OF ONCOGENE AND TUMOR SUPPRESSOR GENE EXPRESSION 
IN NON-SMALL CELL LUNG CANCER , , #9209-031/DR. ROTH 
Dr. Walters called on Dr. Miller to present an update on the protocol submitted by Dr. 
Jack Roth of MD Anderson Cancer Center, Houston, Texas, that was approved with 
contingencies at the September 1992 RAC meeting. Dr. Miller summarized the 
chronology of events that have transpired since September 1992. RAC approval of Dr. 
Roth's protocol was contingent on: (1) submission of data demonstrating the 
transforming potential of 100 ml of retroviral supernatant analogous to the preparation 
that will be used for the clinical protocol, (2) submission of data obtained from in vitro 
mixing experiments, (3) submission of in vitro data demonstrating that the new vector 
preparations have activity, and (4) incorporation of minor changes in the Informed 
Consent document as noted by Drs. Carmen and Hirano. 
On May 11, 1993, Dr. Roth submitted data in response to the stipulations and requested 
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