Pilot Study of Iodine-124 Labeled Chimeric G250 (124 I-cG250) in Presurgical Patients With Renal Masses
Antibodies are blood proteins made by the immune system. They fight things that the body
sees as foreign, such as bacteria and viruses. The body can also see cancer cells as
foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader.
Once this happens, the immune system can work to destroy whatever is that the antibody has
Monoclonal antibodies are ones that can be made in the lab. They tag a portion of a cancer
cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an
antibody response in humans after one dose. Now they are more like human antibodies, and
thus, do not produce the same reactions on repeated doses. These are called chimeric
antibodies. The antibody we will use in this study is called chimeric G250 (cG250).
Recent research has shown that some antibodies can attach themselves to cancer cells, and
that they bind to very few normal cells. This could help cancer treatment in two ways. One
is that the body's own immune system might work to destroy tagged cancer cells. The other
is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These
can then deliver treatment when the antibodies attach to the cancer cells.
This study is being done to test the tagging ability of cG250 to cancer cells. After you
receive cG250, you will have a scan. The picture the scan produces will show where the
antibody has collected inside the body. From this, it is possible to measure how well cG250
can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we
will examine the tumor and other tissue to see how much of the antibody has attached to the
Fifty four patients are expected to be treated in this study.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
-Binary reading of 124I-cG250 based PET/CT imaging in renal mass and adjacent normal organ tissues
Chaitanya R Divgi, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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