Recombinant DNA Advisory Committee - 06/1-2/92 
2 has been approved by the FDA for patients with renal cell cancer, it is not necessarily 
considered a standard therapy. Dr. Gansbacher suggested that the language could be 
modified in the informed consent document so that patients can enter the protocol only 
if they have failed all standard treatments, i.e., failed radiation therapy, surgery, and at 
least one other course of treatment. 
Dr. Kelley inquired as to the response rate of patients receiving IL-2 therapy alone. Dr. 
Gansbacher stated that the response rate is in the range of 20-25%. 
Dr. Parkman stated that an inclusion criterion of failure to respond to systemic IL-2 
therapy would give more credibility to this protocol if patients respond to modified 
tumor cells. A response to modified tumor cells and not to systemic ID2 would indicate 
that IL-2 is necessary at the site where the effector cell is killing the tumor cell. Dr. 
Gansbacher said that he was concerned that this criterion would greatly limit the patient 
population for this study. 
Dr. Kelley said that the investigators may want to exclude patients who have previously 
received systemic IL-2 therapy because they may have generated an antibody response to 
IL-2, resulting in a failure to respond. Dr. Gansbacher acknowledged that an IL-2 
antibody response is of great concern because these responses have been documented in 
patients previously. 
Mr. Capron asked if recombinant IL-2 is used presently as a last line of treatment after 
radiation therapy or chemotherapy for patients with renal cell carcinoma? Dr. 
Gansbacher responded that patients are presented with several protocol options at 
Memorial Sloan-Kettering. There is no standard therapy for patients with this disease. 
The treatment available to these patients is based mostly on the stage of their disease. 
Dr. Kelley said that there would be an advantage to offering this protocol to patients 
who received IL-2 previously in addition to patients who had not received IL-2. This 
comparison would provide information regarding possible toxic effects of the combined 
therapies. Dr. Gansbacher noted that the protocol is now designed so that both patient 
populations can be treated. 
In response to Dr. Kelley's question regarding the use of the proposed cell line in 
patients, Dr. Gansbacher replied that SK-RC-28 was derived from a patient who had a 
solitary bone metastasis. This irradiated cell line was used as an autologous vaccine. 
This patient is doing very well at the present time. These cells have never been used in 
the allogeneic setting. Dr. Kelley suggested that if this therapy proves to be a successful 
treatment for renal cell carcinoma, the investigators should propose to inject unmodified 
tumor cells because they will need to demonstrate whether the effect is a result of the 
irradiated tumor cells or the inserted gene. Dr. Gansbacher responded that data 
Recombinant DNA Research, Volume 15 
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