50
Participants
Start Date
December 31, 2011
Primary Completion Date
January 31, 2022
Study Completion Date
January 31, 2022
Radioactive iodine-labeled monoclonal antibody omburtamab
Prior to treatment children will be pre-medicated with super-saturated potassium iodide \& liothyronine to prevent thyroid uptake of the therapeutic radioisotopes. The proposed intervention is a surgical procedure using interstitial infusion of the radiolabeled monoclonal antibody 124I-omburtamab into the brain stem tumor. This will be performed by stereotactic placement of a small caliber infusion cannula into the tumor followed by a slow infusion (CED) of 124I-omburtamab. Following treatment, these children will be monitored during inpatient hospitalization with clinical evaluations \& PET/CT or PET/MRI scans of the brain \& other organs. Clinical observations, intensive care unit monitoring, routine blood \& interval imaging studies (MRI \& PET/CT or PET/MRI scans) will be performed at predetermined time points. If the PET/CT scan happens to fall on a weekend or holiday, the scan may be done before or after at the discretion of the Study PI. This will not affect dosimetry interpretation.
External Beam Radiotherapy
Standard radiation therapy is given 4-6 weeks prior to study entry.
Weill Medical College of Cornell University, New York
Memorial Sloan Kettering Cancer Center, New York
Lead Sponsor
Memorial Sloan Kettering Cancer Center
OTHER
Y-mAbs Therapeutics
INDUSTRY