Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199888
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2005-09-13
Brief Title:
Safety Study With the Antibody cG250 and Isotope 124-Iodine to Diagnose Patients With Renal Masses
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Pilot Study of Iodine-124 Labeled Chimeric G250 124I-cG250 in Presurgical Patients With Renal Masses
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Antibodies are 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 the antibody has tagged
Monoclonal antibodies are antibodies 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 bodys 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
Monoclonal antibodies are antibodies 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 bodys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC IRB 05-004 | OTHER | MSKCC | None |