Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00199888|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 30, 2006
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Kidney Kidney Cancer Renal Cancer Neoplasms, Kidney Renal Neoplasms||Drug: 124-Iodine-cG250 (124I-cG250)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Iodine-124 Labeled Chimeric G250 (124 I-cG250) in Presurgical Patients With Renal Masses|
|Study Start Date :||February 2005|
|Study Completion Date :||June 2006|
- -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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|