Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
NCT ID: NCT01502917
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2011-12-31
2022-01-31
Brief Summary
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Omburtamab is something called an antibody. Antibodies are made by the body to fight infections and sometimes cancer. The antibody omburtamab is produced by mice and can attack many kinds of tumors. A radioactive substance, 124I-omburtamab, is attached to omburtamab. 124I-omburtamab sticks to parts of tumor cells and can cause the tumor cells to die from radiation. Studies have also been done on humans using 124I-omburtamab to treat other kinds of cancer. Our studies of some DPG and related tumors suggest that omburtamab will bind to the tumor, but the investigators don't know that for sure.
In this study, the researchers want to find out how safe 124I-omburtamab given by CED is at different dose levels. They will look to see what effects (both good and bad) it has on the patient. The dose of 124I-omburtamab will increase for each new group of patients. The procedure has already been safely performed with lower doses and infusion volumes in a number of patients here at MSKCC. The amount they get will depend on when they enter the study. If too many serious side effects are seen with a certain dose, no one will be treated with a higher dose, and some more patients may be treated with a lower dose to make sure that dose is safe.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Radioactive iodine-labeled monoclonal antibody omburtamab
This is a therapeutic Phase I study intended to assess the safety of convection-enhanced delivery (CED) of radioimmunotherapy in the treatment of children with diffuse pontine glioma.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* The patient must have undergone prior external beam radiotherapy to a dose of 54-60 Gy to the brain stem. At least 4 weeks but no more than 14 weeks must have elapsed from the completion of radiotherapy.
* The patient must be in adequate general condition for study, with Lansky or Karnofsky Performance Score of ≥ 50 at study entry .
Lansky Performance scale will be used for patients ≤16 years of age.
* The patient must be ≥ 2 and ≤ 21 years old.
* Patient must weigh a minimum of 8 kg.
Exclusion Criteria
* Metastatic disease.
* Untreated symptomatic hydrocephalus determined by treating physician.
* AST or ALT \> 2x the upper limit of normal.
* Platelets \< 100,000/mcL.
* ANC \< 1000/mcL.
* Abnormal PT (Inr) \>1.5 INR or PTT \> 42 sec (may be corrected with FFP, cryoprecipitate, vitamin K, etc).
* Total bilirubin \> 2.0 mg/dl.
* Serum creatinine \> 1.5x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR \< 70 ml/min/1.73 m2.
2 Years
21 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Y-mAbs Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Souweidane, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Weill Medical College of Cornell University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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References
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Souweidane MM, Bander ED, Zanzonico P, Reiner AS, Manino N, Haque S, Carrasquillo JA, Lyashchenko SK, Thakur SB, Lewis JS, Donzelli M, Cheung NV, Larson SM, Kramer K, Pandit-Taskar N, Dunkel IJ. Phase 1 dose-escalation trial using convection-enhanced delivery of radio-immunotheranostic 124I-Omburtamab for diffuse intrinsic pontine glioma. Neuro Oncol. 2025 Sep 17;27(8):2117-2126. doi: 10.1093/neuonc/noaf039.
Bander ED, Ramos AD, Wembacher-Schroeder E, Ivasyk I, Thomson R, Morgenstern PF, Souweidane MM. Repeat convection-enhanced delivery for diffuse intrinsic pontine glioma. J Neurosurg Pediatr. 2020 Sep 25;26(6):661-666. doi: 10.3171/2020.6.PEDS20280. Print 2020 Dec 1.
Morgenstern PF, Zhou Z, Wembacher-Schroder E, Cina V, Tsiouris AJ, Souweidane MM. Clinical tolerance of corticospinal tracts in convection-enhanced delivery to the brainstem. J Neurosurg. 2018 Dec 21;131(6):1812-1818. doi: 10.3171/2018.6.JNS18854. Print 2019 Dec 1.
Souweidane MM, Kramer K, Pandit-Taskar N, Zhou Z, Haque S, Zanzonico P, Carrasquillo JA, Lyashchenko SK, Thakur SB, Donzelli M, Turner RS, Lewis JS, Cheung NV, Larson SM, Dunkel IJ. Convection-enhanced delivery for diffuse intrinsic pontine glioma: a single-centre, dose-escalation, phase 1 trial. Lancet Oncol. 2018 Aug;19(8):1040-1050. doi: 10.1016/S1470-2045(18)30322-X. Epub 2018 Jun 18.
Ivasyk I, Morgenstern PF, Wembacher-Schroeder E, Souweidane MM. Influence of an intratumoral cyst on drug distribution by convection-enhanced delivery: case report. J Neurosurg Pediatr. 2017 Sep;20(3):256-260. doi: 10.3171/2017.5.PEDS1774. Epub 2017 Jul 7.
Guisado DI, Singh R, Minkowitz S, Zhou Z, Haque S, Peck KK, Young RJ, Tsiouris AJ, Souweidane MM, Thakur SB. A Novel Methodology for Applying Multivoxel MR Spectroscopy to Evaluate Convection-Enhanced Drug Delivery in Diffuse Intrinsic Pontine Gliomas. AJNR Am J Neuroradiol. 2016 Jul;37(7):1367-73. doi: 10.3174/ajnr.A4713. Epub 2016 Mar 3.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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11-011
Identifier Type: -
Identifier Source: org_study_id