Recombinant DNA Advisory Committee - 06/1-2/92 
receive three standard chemotherapy cycles, and their harvest will be performed soon 
after the last cycle. 
Dr. Dunbar responded to Dr. Geiduschek's questions regarding the possibility of 
observing variable outcomes with these three protocols resulting from the different 
procedures in each protocol. Obviously, this study is not controlled; these are different 
diseases. If every myeloma patient has a high level of marking and the breast cancer 
patients do not, 5-FU will be suspect as an important conditioning regimen. 
Following bone marrow harvest, 30% of the marrow will be CD34( + ) enriched and 
marked by either the LNL6 or GINa vectors. Enough peripheral blood and bone 
marrow will be obtained so that there will be a back up supply should there be 
contamination or failure to engraft. These protocols vary from the one proposed by Dr. 
Deisseroth in that he will be performing CD34( + ) selection of the entire fraction. Dr. 
Dunbar explained that she will be selecting only 30% of the cells. 
Dr. D. Miller asked if the investigators have observed long-term reconstitution using 
peripheral blood stem cells? Dr. Dunbar responded that they are not proposing 
peripheral blood reconstitution alone in these patients; however, these experiments have 
been performed successfully in patients using mobilized cells. 
Dr. Parkman asked if the addition of IL-3, IL-6, and SCF to autologous stroma would 
improve the procedure? Dr. Dunbar stated that Dr. Deisseroth has more expertise using 
these growth factors in addition to autologous stroma. The results were relatively 
equivalent with or without autologous stroma; therefore, autologous stroma was not used 
for these studies. There are plans to develop stromal lines that will provide better 
results than regular autologous stroma. 
Dr. Walters asked Dr. Dunbar to explain why she intends on keeping the consent forms 
separate for the therapeutic and gene marking protocols. Dr. Dunbar explained that the 
separation of forms allows the patient to agree to the autologous transplant without 
agreeing to the genetic marking procedure. Dr. Walters said it was his understanding 
that Dr. Dunbar did not want the consent forms divided. Dr. Dunbar apologized and 
said that she misunderstood what the separation entailed. Dr. Dunbar said that she did 
not want a consent form written in technical language versus a form written in simplified 
language. 
Dr. D. Miller asked if CELLPRO® has agreed to supply the CD34( + ) selection columns? 
Dr. Dunbar stated that CELLPRO® will be providing the selection columns, and that 
they have already performed numerous selections with cells obtained from normal 
volunteers. 
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Recombinant DNA Research, Volume 15 
