Recombinant DNA Advisory Committee - 06/1-2/92 
treatment to assay for virus. Dr. Brenner responded that the patients will be monitored 
for the retroviral marker; however, he is not planning to screen the neuroblastoma cell 
lines. Dr. Brenner added that he would include cell line screening if the RAC requested 
this procedure. Dr. Brenner noted that if cell line screening is included as part of the 
inclusion criteria for the protocol, then every patient would be included; this procedure 
should not be performed at random. Dr. Leventhal asked if the investigators will assay 
for retroviral markers present in residual tumor by biopsy of distant sites or by biopsy at 
the time of autopsy. 
Dr. Leventhal noted that several patients may exhibit stable disease for up to four weeks 
following the initial cell injection; however, this result may not be the direct related to 
treatment. Will these patients receive more injections? If so, these procedures should 
be more clearly stated in the informed consent document. Children are very concerned 
about the number of shots they are going to receive. Dr. Brenner replied that the 
consent form clearly states that the patient may receive more courses of treatment; 
however, the number of injections will be defined further. 
In response to Dr. Leventhal's question regarding the biopsy of distant tumors, Dr. 
Brenner said that distant tumors will be biopsied only if it is indicated for other clinical 
reasons. 
Dr. Brenner addressed Mr. Capron's concerns regarding the exclusion of HIV( + ) 
patients from the protocol. Dr. Brenner explained that since HIV is another retrovirus, 
the presence of HIV would only complicate the safety issues regarding virus rescue. 
Dr. Brenner addressed the issue of patient options. There is no other curative therapy 
available to patients who meet the eligibility criteria for this experiment; this is a fatal 
disease. Dr. Post inquired if patients who have failed a bone marrow transplant would 
be eligible for this protocol. Dr. Brenner replied that these patients would be eligible 
for the study. 
Dr. Brenner said that the patients could be eligible for more than just the original gene 
marking protocol. If the marking protocol has been successful, patients would be eligible 
for the bone marrow purging protocol. The vectors used for these two studies are 
distinguishable. 
Ms. Meyers noted that a section should be included in the informed consent document 
regarding the request for autopsy. In addition, patients should be informed about their 
rights to protection from publicity. Dr. Brenner replied that the publicity concerns were 
addressed in the statement of understanding which is part of the informed consent. Dr. 
Brenner said that he would include a request for autopsy statement in the informed 
consent document as requested by Ms. Meyers. 
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Recombinant DNA Research, Volume 15 
