Recombinant DNA Advisory Committee - 03/1-2/93 
mutagenesis. In addition, vector producing cells will be assayed for replication 
competent retrovirus. This treatment should not present any added risk to the patient, 
i.e., administration of MDR-resistant breast cancer cells. In order to impose increased 
risk to the patient, transduced tumor cells would have to demonstrate biologic virulence 
that would cause them to repopulate the marrow. Otherwise, there is very little 
consequence; because it is rare that the bone marrow is the site of tumor recurrence. 
Ms. Meyers inquired about the financial responsibility for the costs associated with the 
proposed study. Dr. Hesdorffer stated that arrangements will be made with third-party 
carriers to cover the costs associated with the ABM transplantation procedures. Any 
costs specifically related to the transduction of the cells will not be covered by the 
institution. Additional procedures such as blood tests, bone marrow harvest, and any 
pre- and post-transplantation procedures will be billed to third-party carriers. 
Ms. Meyers asked who would be responsible for the costs associated with adverse side 
effects should any arise as a result of the gene transfer procedure. Dr. Bank answered 
that the patient's third-party carrier would be billed for such costs. Dr. Hesdorffer stated 
that if toxic side-effects occur as a result of the Taxol administration, a third-party carrier 
would be charged for costs associated with treatment; however, adverse effects relating 
to the gene transduction procedure would be covered by Columbia University. Ms. 
Meyers inquired if the institute would cover any injury not related to Taxol 
administration or bone marrow transplantation. Dr. Bank agreed that the institution 
would cover these injuries. 
In response to the issue of whether the investigators would seek NIH approval for 
compassionate use of this protocol for patients who do not meet the eligibility 
requirements, Dr. Bank said that Columbia University would probably not pursue such a 
request, because there are numerous breast cancer research protocols to which patients 
could be referred. He noted that full IRB approval has been obtained and is available. 
Dr. Post asked if the investigators have data using the exact packaging cell line and 
vector that is being proposed of this study. Dr. Bank responded that the only data 
available with the proposed vector are reverse transcriptase (RT) assays on supernatant 
from the transduced bone marrow cells. Dr. Bank stated that S + L' assays and co- 
cultivation with Mus dunni cells have not been performed. The proposed packaging cell 
line has been used with other vectors in over 300 laboratories throughout the world 
without any incidence of RCR breakout. 
Dr. Miller asked whether any of these laboratories have assayed for helper virus. Dr. 
Bank said that approximately 20 of the 300 laboratories had tested for helper virus. Dr. 
Miller said that experiments must be performed with the proposed packaging cell line 
and vector in order to demonstrate that helper virus has not been produced. With 
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