Recombinant DNA Advisory Committee - 12/2-3/93 
Dr. Secundy inquired about the length of time required to perform the necessary 
experiments. Dr. Miller explained that the requested assays are relatively simple, taking 
only a few hours to set up, with several weeks of observation before the results are 
obtained. Time and cost are several reasons cited by Dr. Roth for not performing these 
experiments. Dr. Miller said that the investigator has stated that the protocol is justified 
on the basis that the proposed patient population is terminally ill. Dr. Chase said that 
this latter rationale is invalid. Dr. Walters stated that the consensus of the committee 
should be obtained with regard to recommendations for this protocol. 
Dr. Post suggested that because of the lengthy delays that have occurred, the protocol 
should be resubmitted for reconsideration by the full RAC. Drs. DeLeon, Krogstad, and 
Ms. Grossman supported this suggestion. Dr. Geiduschek stated that a protocol cannot 
be considered approved by the RAC unless all stipulation requirements have been met. 
Dr. Leventhal suggested that the protocol should be resubmitted, and that different 
primary reviewers should be assigned. Dr. Parkman said that approval of this protocol 
should be considered administratively inactivated due to failure to meet the stipulation 
requirements. 
Committee Consensus 
The consensus of the RAC was that Dr. Roth should resubmit a revised protocol, 
including all additional data, for review and approval by the full RAC based on the 
following: (1) failure of the primary reviewers to recommend approval of the protocol, 
(2) lengthy delays that have occurred, (3) there are several new members on the RAC 
who were not on the committee at the time the original protocol was reviewed, and (4) 
Dr. Roth has requested the use of a substitute vector. If Dr. Roth submits a revised 
protocol, new primary reviewers will be assigned. The consensus of the RAC is that the 
protocol is considered administratively inactivated; therefore, RAC approval of the 
protocol is withdrawn. The RAC recommended that ORDA forward a letter to Dr. 
Roth outlining the consensus of the RAC. 
XVII. ADDITION OF APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
GENE TRANSFER PROTOCOL ENTITLED: ADOPTIVE IMMUNOTHERAPY OF 
MELANOMA WITH ACTIVATED LYMPH NODE CELLS PRIMED IN VIVO WITH 
AUTOLOGOUS TUMOR CELLS TRANSDUCED WITH THE IL-4 GENE/DR. CHANG 
Review--Dr. Geiduschek 
Dr. Walters called on Dr. Geiduschek to present his primary review of the protocol 
submitted by Dr. Alfred E. Chang of the University of Michigan, Ann Arbor, Michigan. 
Dr. Geiduschek explained that this protocol is an extension of an ongoing non-gene 
transfer adoptive immunotherapy protocol for renal cell carcinoma and melanoma in 
which patients are vaccinated with their own tumor cells that have been lethally 
irradiated, mixed with BCG (Bacille Calmette-Guerin) adjuvant, and injected in the 
vicinity of lymph nodes, which are subsequently removed. Lymphocytes from these 
excised lymph nodes are stimulated by exposure to a monoclonal anti-CD3 antibody and 
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Recombinant DNA Research, Volume 18 
