Recombinant DNA Advisory Committee - 06/1-2/92 
Gansbacher suggested that the inclusion/exclusion criteria be changed to include patients 
with a life expectancy of more than four months and less than one year in order to limit 
the patient population. Ms. Meyers said that this criterion would be acceptable. 
Dr. D. Miller asked if no response is observed in these patients, will an attempt be made 
to insert cells that secrete higher levels of IL-2? Dr. Gansbacher replied that the lack of 
response may not result from the lack of IL-2 production; lack of response may reflect 
the degree to which the tumor antigen is presented. Therefore, if no responses are 
observed with this protocol, a revised protocol will be submitted using the MAGE-1 
HLA-A1( + ) melanoma cells line transduced with IL-2. This cell line would allow 
presentation of a well defined tumor specific antigen that is measurable. Consequently, 
the patient eligibility requirements would change. This scenario can be manipulated 
because Class I antigens can be upregulated. 
Dr. Bourquin asked about follow up in patients that withdraw from this protocol? Dr. 
Gansbacher replied that he has included the following sentence in the informed consent 
document, "Even if you withdraw from the study, we will ask to continue to monitor the 
state of your disease. Should you die we will ask for an autopsy". 
Dr. Carmen submitted proposed language changes to both the melanoma and the renal 
cell protocol informed consent documents regarding a description of the retroviral vector 
as a mouse virus that will contain the gene for IL-2 as well as a bacterial marker gene. 
Dr. Gansbacher accepted these changes with minor modifications. 
Committee Motion 
Dr. Kelley moved for approval of the melanoma protocol. The motion was seconded by 
Dr. Haselkom. Ms. Meyers asked if the change in inclusion and exclusion requirements 
for the patients could be included as part of the motion. Dr. Kelley stated that including 
only those patients with a life expectancy of greater than four months and less than one 
year is too restrictive, and it will be difficult to accrue patients. Dr. Gansbacher agreed 
and suggested that he would agree to limit patient eligibility to those patients who have 
failed primary chemotherapy. This statement was agreeable to Ms. Meyers. 
The motion to approve the metastatic melanoma protocol passed by a vote of 20 in 
favor, 0 opposed, and no abstentions with the following stipulations: (1) the patient 
eligibility criteria is defined as those patients who have a life expectancy of greater than 
four months and who have failed one course of conventional therapy, and (2) revised 
language regarding the retroviral vector will be included in the informed consent 
document. 
Renal Cell Carcinoma Protocol 
Recombinant DNA Research, Volume 15 
[713] 
