Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9|
- Define the level of agreement between 131-I-8H9 and conventional imaging modalities in the detection of primary and metastatic 8H9-positive solid tumors in pediatrics. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Estimate the radiation dose per mCi of 131-I-8H9 delivered to blood, and the relative uptake of tumors versus normal organs in patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2001|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Drug: MAB 131-I LABELED 8H9
This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582608
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Shakeel Modak, MD||Memorial Sloan Kettering Cancer Center.|