Recombinant DMA Advisory Committee - 6/9-10/94 : 
Statement in item 11: "Please see item 3 for costs that wiU not be charged to you in this ' 
study." Ms. Buc said that the statement as written in item 11 is uninformative as to 
covered costs and is inconsistent with the statement in item 3. 
Responding to Dr. Parkman's question regarding the possibility of a negative outcome of 
this study, i.e., non-specific trafficking of TIL to tumor, Dr. Freedman stated that the TTL 
trial will continue regardless of the outcome of the marking study. Dr. Parkman said | 
that conducting a study that will not impact the future course of investigation is | 
inconsistent with the strategy of conducting clinical research. Dr. Chris Platsoucas of 
Temple University (a co-investigator) explained that mechanisms other than TIL cell | 
trafficking, e.g., enhanced cytokine production by TIL may contribute to the antitumor | 
effect; therefore, the TIL trial should continue regardless of the outcome of the marking 
study. 
Dr. Post inquired whether this protocol would have been considered exempt under the ! 
AcQelerated Review process. Dr. Wivel responded that this protocol is a resubmission of ' 
a protocol that was deferred by the RAC; therefore, the Accelerated Review guidelines 
are not applicable. I 
Committee Motion 
Dr. Dronamraju made a motion to approve the protocol with a request to resolve the i 
discrepancy regarding items 3 and 11 of the Informed Consent document as previously 
suggested by Dr. Zallen. 
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The RAC approved a motion made by Dr. Dronamraju and seconded by Dr. Post to 
accept the protocol submitted by Dr. Ralph Freedman of MD Anderson Cancer Center, 
Houston, Texas, by a vote of 13 in favor, 1 opposed, and no abstentions. 
VII. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN ' 
GENE TRANSFER PROTOCOL ENTITLED: USE OF DOUBLE MARKING WITH j 
RETROVIRAL VECTORS TO DETERMINE THE RATE OF RECONSTITUTION OF 
UNTREATED AND CYTOKINE EXPANDED CD34(+ ) SELECTED MARROW CELLS \ 
IN PATIENTS UNDERGOING AUTOLOGOUS BONE MARROW 
TRANSPLANTATION /HRS. HESLOP, BRENNER AND KRANCE i 
f 
Review— Dr. Miller !, 
I, 
Dr. Walters called on Dr. Miller to present his primary review of the protocol submitted | 
by Drs. Helen Heslop, Malcolm Brenner, and Robert Krance of St. Jude Childrens j 
Research Hospital, Memphis, Tennessee. Dr. Miller explained that autologous bone | 
marrow transplantation (ABMT) is often used in pediatric patients to allow the j 
administration of high dose chemotherapy. Bleeding and infection are risks often 
associated with ABMT. To improve ABMT methods, the marrow is often pre-incubated | 
with growth factors that increase the rate of engraftment. If engraftment can be I 
significantly enhanced, smaller amounts of marrow may be harvested in the future. The i 
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