Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

January 31, 2022

Study Completion Date

January 31, 2022

Conditions
Brain CancerBrain Stem Glioma
Interventions
DRUG

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.

RADIATION

External Beam Radiotherapy

Standard radiation therapy is given 4-6 weeks prior to study entry.

Trial Locations (2)

10021

Weill Medical College of Cornell University, New York

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors
All Listed Sponsors
collaborator

Memorial Sloan Kettering Cancer Center

OTHER

lead

Y-mAbs Therapeutics

INDUSTRY