Recombinant DMA Advisory Committee - 6/9-10/94 
number of important questions that should be addressed; therefore, approval as a minor 
modification is not appropriate. The investigators proposed transduction of peripheral 
blood mononuclear cells rather than bone marrow cells in order to reduce the 
probability of transducing contaminating cancer cells in the marrow. What is the 
probability of tumor cell contamination? In their written response, the investigators 
stated that the immunohistochemical assay is capable of detecting 1 contaminating 
cancer cell in 100,000 normal cells. The investigators provided published data on assay 
sensitivity. Dr. Deisseroth was asked to expand on the ability of his laboratory to 
perform these assays at the same level of sensitivity. Dr. Brinckerhoff asked the 
investigators to respond to the following questions during his oral presentation: (1) Is 
the transduction rate of peripheral blood mononuclear cells as efficient as that of bone 
marrow cells? (2) Will increased doses of Taxol exceed the capacity of the MDR-1 
transduced cells to confer resistance? Dr. Brinckerhoff stated that if satisfactory 
responses are provided to all of these concerns, approval of the protocol is 
recommended. 
Review-Dr. Dronamraju 
Dr. Dronamraju expressed concern about the Informed Consent document statement, 
"costs related to my medical care including expensive drugs, tests or procedures... 
required by this clinical research study shall be my responsibility." TTiis statement poses 
ethical and moral dilemmas and will preclude participation if the patient's financial 
status changes during the course of their participation in the study. Dr. Dronamraju 
inquired about the transduction efficiency. In the investigator's written response, they 
stated that the transduction rate for peripheral blood cells is as efficient as bone marrow 
cells. The investigators anticipate that approximately 50% of the subjects entered on the 
study will complete the protocol. Patients will be followed systematically for 5 years. 
Review-Ms. Meyers (Presented by Dr. Dronamraju) 
Dr. Dronamraju summarized the written comments submitted by Ms. Meyers on the 
Informed Consent document. Ms. Meyers suggested the following: (1) patient follow-up 
should be for life rather than for 5 years, (2) the vector manufacturer should be added as 
a party who may access patients' medical records, and (3) patients who are poor or 
uninsured should not be excluded from participation in the protocol. In the 
investigators' written response, they stated that MD Anderson Cancer Center will 
provide free care to uninsured residents of Texas. 
Other Comments 
Dr. Parkman asked about patient accrual in the ovarian cancer protocol (Protocol 
#9306-044). Dr. Smith asked if there is an exclusion criterion based on a defined 
number of contaminating breast cancer cells in the marrow. 
Investigator Response-Dr. Deisseroth 
Recombinant DNA Research, Volume 19 
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