other than utilization of indium-111 labeled autologous TIL to 
monitor trafficking of both the lymphoid cells to tumor deposits, 
or to other parts of the reticuloendothelial system. 
Dr. Rosenberg said that if cells could be produced incorporating 
genes for other cytokines such as tumor necrosis factor or alpha- 
interferon, they could be utilized in the mechanism of cancer 
killing, thus, dramatically improving the effectiveness of this 
treatment approach. He hoped to return to the RAC and ask 
permission to introduce genes with therapeutic potential into 
humans to improve this therapy. 
Dr. Rosenberg related that in the search for new cancer 
treatments. Phase I protocols that have a 10-20 percent 
treatment-related mortality are being considered daily by 
clinical research committees. Because of the low additional risk 
posed by the gene transfer procedure. Dr. Rosenberg felt that it 
was worthy of careful consideration and approval. 
Dr. Neiman asked if a dose-response curve had been constructed, 
based on the n 1 nber of TIL administered to the patients. 
Dr. Rosenberg id they intended to administer as many cells as 
can be grown i.. '-4 weeks and attempt to transfer somewhere 
between one and X 10“ of these TILs. His response to 
Dr. Neiman 's ques on was that a correlation between number of 
cells transferred nd anti-tumor response has not been 
established in the small number of patients treated to date. 
Dr. Rosenberg then called on Dr. Blaese to present further 
information on the protocol. 
Dr. Blaese said that when he began his work in gene transfer 
technology, its use in the treatment of cancer was not 
anticipated. It was thought more likely that the first diseases 
to be dealt with would be genetic diseases such as adenosine 
deaminase deficiency (ADA). However, as work with lymphocytes in 
culture progressed, it rapidly became apparent that one of the 
attractive features of these cells was their capacity to act as 
cellular vehicles for gene therapy. The protocol now before the 
RAC was developed as a result of such experimentation. 
The investigators seek to answer the following key questions: 
1. How long do the TIL persist in vivo ? 
2. Where are they located in the body? 
3. Does longevity or location correlate with 
clinical effect? 
4. Is it possible to recover the TIL? 
Recombinant DNA Research, Volume 13 
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