Recombinant DNA Advisory Committee - 03/1-2/93 
Review— Ms. Meyers 
Ms. Meyers stated that this protocol is the logical next step in a series of protocols that 
have been initiated by the investigators. The initial concerns about the informed consent 
document have been adequately responded to, except for the addition of a request for 
autopsy in the parent consent form. Dr. Brenner had stated that it is the policy of St. 
Jude Children's Research Hospital to verbally notify all patients and their parents that 
an autopsy will be requested in the event of death; however, this statement is not 
included in the informed consent document. Ms. Meyers stated that it is important that 
this statement be reflected in the parent consent form. 
Other Comments 
Dr. Parkman inquired whether the IL-2 purging procedure will be performed in 
Vancouver; and if so, will the bone marrow cells be shipped? If the cells are shipped, 
what are the risks involved? In addition, there will be a 6 hour delay between cell 
isolation and 4-HC purging due to the transduction procedure. Is the sensitivity of the 
leukemic or normal cells to 4-HC affected by the long incubation period? 
Dr. Post asked the investigators to provide information about the patients who have 
received transduced cells and not relapsed on their previously approved protocols. Do 
they have marked cells? Do you have data regarding the efficacy of transduction, etc.? 
Dr. Haselkorn noted that other investigators have utilized other purging methods such as 
magnetic bead/antibody selection procedures. Why has 4-HC and IL-2 activation been 
chosen over other selection procedures? 
Presentation-Dr. Brenner 
Dr. Brenner stated that 12 patients will be entered onto this protocol per year. At the 
end of each year the results of the protocol will be assessed. The ongoing study was 
initiated in September 1991, and 12 patients have been entered onto the protocol. Two 
of these patients have relapsed; both of these have been marked. In addition, a third 
patient has relapsed as demonstrated by cytology; however, this patient has not been 
clinically determined to be in relapse. A maximum number of 35 patients will be 
enrolled only if no marked relapses have been observed. A significant number of 
marked relapses will indicate reconsideration of the protocol. 
In response to Ms. Meyers' concerns about the request for autopsy in the informed 
consent document, Dr. Brenner said that he did not believe that the St. Jude's IRB will 
ever approve such a statement. Dr. Brenner noted that there have been 4 patient deaths 
to date that have not been associated with the gene marking procedure, and that all 4 
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