Recombinant DNA Advisory Committee - 6/9-10/94 
Dr. Brinckerhoffs written comments were presented by Dr. Dronamraju. Dr. 
Brinckerhoff states that the investigator has adequately responded to the issues 
previously raised by the RAC; therefore, approv^ of the protocol is recommended. Dr. 
Brinckerhoff recommended that for future protocols, investigators should present their 
protocol in a logical emd thoughtful manner with supporting data and sufficient detail. 
Review-Dr. Secundy (presented by Dr. Dronamraju) 
Dr. Dronamraju summarized Dr. Secundy's written comments regarding the Informed 
Consent document. Dr. Secundy recommended that language should include the 
provision of medical care for any adverse effect that may possibly result from the 
treatment. 
Other Comments 
Dr. Zallen commented on the inconsistency of statements regarding medical costs in the 
Informed Consent document. Item 11, which appears to be a standard statement 
required by the Institutional Review Board (IRB) of MD Anderson Cancer Center, 
stated that if the investigational agents become commercially available during the course 
of this study, the patients may be required to cover the cost of subsequent doses. The 
document states that costs related to medical care, including expensive drugs, tests, or 
procedures, shall be the patient's responsibility unless other funding sources contribute 
toward the costs. This statement is inconsistent with that in item 3, i.e., that there is no 
cost to the patients for the preparations of cells, viruses, or laboratory tests. Dr. Zallen 
asked the investigator to clarify this inconsistency. Dr. Walters added that this same 
concern was raised in Ms. Meyers' written comments. 
Dr. Parkman asked whether the ongoing TIL trials would be discontinued if this marking 
study demonstrates no selectivity or specificity of the TIL cells in tumor versus normal 
tissue. 
Investigator Response-Dr. Freedman 
Responding to Dr. Dronamraju's question regarding 5% marking of infected cells. Dr. 
Freedman said 5% refers to the dilution effect. The TIL cultures are expanded in 2 
bioreactors at a transduction rate of 10%; therefore, each bioreactor will have 5% of the 
transduced cells. Regarding the cost of medical care, subjects will not be required to pay 
for such costs; however, the MD Anderson IRB insists that the statement in item 11 be 
included. Dr. Zallen said that inclusion of two inconsistent statements in the Informed 
Consent document is unacceptable. The costs and risks that are unique should be stated 
explicitly for each protocol rather than inclusion of a general statement in all Informed 
Consent documents. Dr. Freedman responded that he will request that the IRB address 
this issue. Dr. Parkman commented that there are no unique risks associated with this 
marking protocol that do not apply to the ongoing TIL triad except for the neo^ marker 
gene. Dr. Chase agreed with Dr. Zallen's concern about the contradictory statements in 
the Informed Consent document. Dr. Walters suggested inclusion of the following 
Recombinant DNA Research, Volume 19 
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