Recombinant DNA Advisory Committee - 3/3-4/94 
(renal cell carcinoma). 
Dr. Doi asked the investigators to respond to the following questions: (1) Is novel 
information expected based on the new tumor type? (2) Would there be an advantage 
in waiting for the results of Drs. Nabel and Rubin's studies? (3) How many Phase I 
studies of an identical protocol, but with different tumor types, are required to obtain 
significant information? He stated that this protocol is an ideal example of an 
experiment that would qualify for the Accelerated Review process, provided that the 
Informed Consent documents adopted by different institutions are properly reviewed. 
RevieW“Dr. DeLeon 
Dr. DeLeon agreed with Dr. Doi's statement regarding the eligibility of this protocol for 
the Accelerated Review process. Dr. DeLeon inquired about the expertise of the 
investigators at the new site; particularly, the personnel involved in the needle biopsies of 
the tumor nodules. Dr. DeLeon stated that she was satisfied with responses and 
additional information provided by the investigators. Dr. DeLeon made several specific 
suggestions for improving the Informed Consent document: patient follow-up should be 
life-long and the words, "treatment" and "therapy," should be replaced with "procedure." 
There are several inconsistencies between the protocol and the Informed Consent 
document describing the treatment procedures. Dr. DeLeon said that most of the 
suggestions provided in her written review were accepted by the investigators. Dr. 
DeLeon recommended approval of the protocol. 
Other Comments 
Dr. Carmen said that preclinical animal experiments using renal cell carcinoma cells 
were not provided. Dr. DeLeon noted that extensive animal experiments were submitted 
to support Dr. Nabel's original protocol. Dr. Parkman explained that based on published 
data (IL-2 and TIL administration), renal cell carcinoma is the second most responsive 
tumor type to immunotherapy. Since enhanced antitumor responses have been 
demonstrated in Dr. Nabel's melanoma protocol, renal cell carcinoma is logically the 
next tumor to study. Dr. Post said that animal studies are not totally predictive for the 
human immune response; therefore, animal studies should not be an absolute 
prerequisite for these human trials. 
Ms. Grossman inquired whether Dr. Nabel will have an interactive role with the 
Principal Investigators at the other sites. Where is the central laboratory located that 
will perform the immunological assays? How will the results obtained from this multi- 
center trial be collected and evaluated? How will quality control be assured? Dr. 
Walters inquired about the most frequent metastatic sites of renal cell carcinoma? 
Investigator Responses-Dr. Vogelzang 
In response to Dr. DeLeon's question about the qualifications of the investigators, Dr. 
Vogelzang stated that Dr. Gary Sudakoff will perform the sonographically-guided needle 
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