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 method which 
has shown some encouraging results. In this therapy, a part of the patient’s cancer 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 with interleukin-2 ( 
a lymphocyte growth factor). These TIL are given back into the patient through a blood vein. 
These TIL are given with compounds, interleukin-2 and in certain cases also alpha interferon, 
which can increase the patient’s own anti-cancer immune reaction as well as the TIL cell 
response to the cancer cells. 
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 time the TIL cells live in the patient 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 difference between the TIL cells from the patient’s other cells, a 
means to mark or identify the TIL cells is necessary. In other clinical tests with TIL it has been 
shown that the TIL can be marked. This marking involves putting a new gene into 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 patient’s other cells. 
This study differs from other similar studies in that a second population of cells will also 
be infused into the patient along with the TIL. White cells obtained from blood (Peripheral 
Blood Lymphocytes, PBL) will be grown up in the laboratory in a manner similar to TIL cells. 
These cells will be marked with a second (and different) marker. These cells will then be given 
back along with the TIL cells. By using the second marker it will be possible to determine if 
TIL cells are better than PBL cells in their ability to home to the tumor. 
This study also differs from other similar studies in that the TIL cells from some patients 
will be separated into two types of cells, CD4 and CD8. These subfractions of the TIL will be 
studied like the un fractionated TIL for their ability to home better than PBL cells. Additional 
studies will compare CD4 and CD8 TIL cells directly for their homing ability. 
The addition of the markers into a portion of the cells 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 treatment plans to help future patients. The risks associated with 
the gene marking procedure are felt to be small. The opportunity to learn more about TIL 
therapy so that future patients may be helped is the reason for using gene marked cells. 
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