cannot recognize or attack the tumor. 
We have grown tumor cell lines in the laboratory that we believe contains the 
same tumor antigen that your tumor has. We have taken a gene which codes for 
a molecule called B7 and placed it in the melanoma tumor cell lines we have in 
the laboratory. We believe that the tumor cell lines containing the B7 will 
be more able to activate your lymphocytes to recognize tumor antigens and that 
this recognition could cause them to attack your tumor. 
In order to administer treatment, we must first determine if your body cell 
type matches the tumor cell lines we have in the laboratory. We do this by 
determining the expression of specific proteins on the surface of your 
lymphocytes that we obtain prior to the study. The two body cell types that 
match the tumor cell lines we have in the laboratory are HLA-A1 and HLA-A2 . 
If your lymphocytes do not have the markers HLA-A1 cr HLA-A2, you cannot 
receive treatment on this study because your tumor and our tumor cell lines 
would not be matched, and we would attempt to find another treatment for you. 
For treatment, we plan to inject a large number of cells (which are first 
killed by radiation before you receive them) from the tumor cell lines 
containing B7 under your skin. The cells are irradiated to kill them so there 
is little chance that a tumor might grow where we inject the cells. The 
killed tumor cells are injected every two weeks for 3 doses, then once a month 
for 3 doses. We rotate the sites of injection, usually starting in the leg, 
then the arm, then the opposite arm, then the opposite leg, and so on. If you 
are HLA.-A1 as described above, you receive the same dose of the same cell line 
each time. If you are HLA-A2, we alternate treatments with one of three cell 
lines. In either group, you can receive a maximum of 6 treatments. 
An important part of this trial is to determine how many cells we need to give 
and what side effects they will have. We do not anticipate any dangerous side 
effects. Therefore, we will treat groups of patients with each group receiving 
a larger number of killed cells. The purpose of the study is to determine how 
many killed cells we can give safely and whether you develop an immune 
response to the cells as we predict from the laboratory studies. If you are 
in the first or second group of patients, you receive 2 injections (about 2 
inches apart) each time you are scheduled for treatment. If you are in the 
third group, you receive 10 injections each time. Each injection will take 
only a few minutes. 
We do not know if the B7 actually improves the immune response to the cells. 
Therefore, some of you may receive the same killed tumor cell line but not 
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Recombinant DNA Research, Volume 18 
