Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
The purpose of this study is to see if an antibody (cG250)attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.
Cancer of Kidney
Drug: 124-Iodine-cG250 (124I-cG250)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Study of Iodine-124 Labeled Chimeric G250 (124 I-cG250) in Presurgical Patients With Renal Masses|
- -Binary reading of 124I-cG250 based PET/CT imaging in renal mass and adjacent normal organ tissues
- Toxicity defined by NCI Common Toxicity Criteria
- Radioactivity in renal tumor, adjacent normal organ tissue, and serum indicating uptake of 124I-cG250
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||June 2006|
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 tagged.
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 tumor.
Fifty four patients are expected to be treated in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199888
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Chaitanya R Divgi, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Pual Russo, MD||Memorial Sloan Kettering Cancer Center|