Recombinant DNA Advisory Committee - 06/1-2/92 
Review-Dr. Kelley 
Dr. Murray called on Dr. Kelley to review Dr. Gansbacher's renal cell carcinoma 
protocol. Dr. Kelley explained that the protocol is designed to assess the prospect of 
immunizing renal cell carcinoma patients with allogeneic HLA-A2 matched renal cell 
carcinoma cells that have been genetically modified to secrete IL-2. The investigators 
will monitor toxicity, induction of humoral and cell mediated immunity, and antitumor 
effects. The rationale for this protocol is the same as the metastatic melanoma protocol. 
Dr. Kelley stated that he had some of the same concerns that were generated by the 
metastatic melanoma protocol as follows: (1) Have studies already been conducted in 
which patients have been immunized with the non-transfected carcinoma cell line 
proposed for use in this protocol? If these studies have been performed, do they provide 
a proper control for the proposed experiments? If they do not provide proper control, 
what controls will be included? (2) Will there be problems associated with the HLA 
Class I alleles that are not matched? (3) Will the trafficking, homing, and persistence of 
the carcinoma cells provide effective immunization? (4) Will trypsinization have an 
effect on the cells? (5) The protocol indicates that immunization will always be with a 
mixture of type A and B histocompatibility types. The proposed renal cell carcinoma 
cell line, SK-RC-28, is ABH type A. Since some of the patients may be Type O, 
circulating anti-A antibodies will destroy or clear the SK-RC-28 cells. Even if 
immunization is successful, would the responses to antigens on the renal cell carcinoma 
cell line be destroyed and cleared rapidly? (6) Will immunization result in immunologic 
auto-reactivity to renal cells? and (7) Can the proposed measures of immune reactivity 
be improved? 
Review-Ms. Meyers 
Ms. Meyers stated that she had the same concerns regarding inclusion and exclusion 
criteria as with the metastatic melanoma protocol. Since IL-2 has been approved for the 
treatment of kidney cancer, IL-2 treatment would be included as a viable treatment 
option for these patients prior to entering the protocol. 
Review-Dr. Bourquin 
Dr. Bourquin suggested that changes should be incorporated into the informed consent 
language regarding patient monitoring following withdrawal from the protocol. 
Other Comments 
Mr. Capron asked Dr. Gansbacher to discuss IL-2 treatment as a possible option for 
patients prior to entering into this protocol. Dr. Gansbacher cautioned that although IL- 
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Recombinant DNA Research, Volume 15 
