Recombinant DNA Advisory Committee - 09/14-15/92 
patient specimens. Statistical analysis indicates that 98% of all neuroblastoma tumors 
will react with one of these antibodies. Dr. Parkman asked if it is an inclusion criterion 
that the patient must demonstrate reactivity with one of the antibodies on the panel. Dr. 
Brenner said that this positive antibody screening is not an inclusion criterion; all 
neuroblastoma patients are eligible for this protocol. 
Dr. Parkman inquired if these antibodies had an effect on hematopoietic progenitor cells, 
specifically, pluripotent hematopoietic stem cells. Dr. Brenner said that data suggests 
that these antibodies cause a slight reduction in the number of CFUs; however, patients 
have been treated with these antibodies and successfully engrafted in less than 43 days. 
Dr. Parkman asked if the period of engraftment is delayed as compared to patients 
receiving unpurged marrow. Dr. Brenner said that engraftment with unpurged marrow 
occurs within the same timeframe; however, no side-by-side comparisons have ever been 
performed. 
Dr. Zallen noted that some patients may enter this protocol from Mt. Sinai Hospital. 
She asked if the statement in the St. Jude informed consent document regarding non- 
negligent physical injury will be included in the informed consent of Mt. Sinai. Dr. Mills 
said that the statement is applicable to all patients entered into this protocol, regardless 
of the institution. 
Dr. Walters asked Dr. Brenner to expand on several issues. How is the study funded? 
How will data be disclosed that emerges from this protocol? Are there any restrictions 
on the disclosure of data? Dr. Brenner said that he is not aware of any restrictions on 
the disclosure of data. With regard to funding, the antibodies and purging devices will 
be supplied by Baxter. The cost of the treatment will be met by St. Jude or third-party 
carriers if they will provide payment. If third-party carriers do not reimburse the costs, 
then St. Jude will cover all costs associated with the treatment. The retroviral vector 
supernatants will be supplied by GTI. 
Committee Motion 
A motion was made by Dr. Haselkom and seconded by Dr. Krogstad to approve the 
protocol. Dr. Murray called for a vote. The motion passed by a vote of 19 in favor, 0 
opposed, and no abstentions. 
XII. OTHER COMMITTEE MATTERS 
Dr. Murray stated that Dr. Anderson has indicated his intention to submit a report that 
will be included as an agenda item for the December RAC meeting. The report will 
detail the safety issues surrounding retroviral supernatant testing. 
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