APPENDIX D 
NONTECHNICAL ABSTRACT OF PROTOCOL 
Many patients have advanced cancer that has not responded to standard therapies. For 
these patients, TIL (tumor infiltrating lymphocyte) therapy offers a new treatment protocol which 
has shown some encouraging results. In this therapy, a portion of the patient’s tumor is 
removed and taken to the laboratory. In the laboratory the tumor portion is processed in a way 
to encourage the growth of white cells, called lymphocytes, which are found in (had infiltrated) 
the tumor. These tumor infiltrating lymphocytes are grown to large numbers in way that kills 
the cancer cells. These TIL are than infused back into the patient through a vein. These TIL 
are given with compounds, interleukin-2 and interleukin-4, which can enhance the anti-tumor 
immune response of the patient as well as the TIL. 
TIL therapy has been shown to be effective in a fraction of patients receiving this 
therapy. At this time it is not known why some patients get a favorable response with TIL 
therapy and some patients do not. In order to further understand TIL therapy, it is important 
to be able to follow the TIL cells after they are given back to the patient. This way it will be 
possible to determine if the length of TIL survival or the ability of the TIL to "home" or return 
to the tumor is related to the response the patient experiences. Since the TIL are from the 
patient, there is no way to distinguish them from the other cells of the patient. In order to tell 
the TIL from the patients other cells, a means to mark the cells is necessary. In other clinical 
tests with TIL it has been shown that the TIL can be marked. This marking involves the 
insertion of a new gene into a portion of the TIL cells by a technique called retroviral-mediated 
gene transfer. These marked TIL can therefore be detected by modem scientific techniques and 
distinguished from the patients other cells. 
The addition of a marker gene into a portion of the TIL will provide no immediate 
benefit for the patient. It would provide useful information about the therapy itself. This 
information may enable the design of better TIL treatment plans to help future patients. The 
risks associated with the gene marking procedure are minimal. The opportunity to leam more 
about TIL therapy so that future patients may be helped is the reason for using gene marked 
TIL. 
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