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NCT01502917 · ClinicalTrials.gov registry record · Phase 1
Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
A Phase 1 study of Brain Cancer and Brain Stem Glioma, sponsored by Y-mAbs Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT01502917 is a Phase 1 study of Brain Cancer and Brain Stem Glioma that has completed, run by Y-mAbs Therapeutics. The registered enrollment target is 50 participants, below the 506-participant average among 47 other Brain Cancer trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01502917, a Phase 1 study of Brain Cancer and Brain Stem Glioma, has completed, sponsored by Y-mAbs Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to deliver an agent called 124I-omburtamab. CED is performed during surgery. The study agent is infused through a small tube placed into the tumor in the brain. Many studies have shown this can safely be done in animals but this study is the first time 124I-omburtamab will be given by CED in humans. This will be one of the first times that CED has been performed in the brain stem. 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.
Conditions Studied
Interventions
- RADIATION External Beam Radiotherapy
- DRUG Radioactive iodine-labeled monoclonal antibody omburtamab
Study Locations (2)
New York
- Weill Medical College of Cornell University - New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-12 |
| Est. Completion | 2022-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01502917
The ClinicalTrials.gov registry entry for NCT01502917 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 506-participant average among 47 other Brain Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Y-mAbs Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Brain Cancer appearing as the primary indexed condition, and to 2 interventions - of which External Beam Radiotherapy is the first listed.
NCT01502917 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01502917 about?
NCT01502917 is a clinical study titled "Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy". The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to deliver an agent called 124I-omburtamab. CED is performed during surgery. The study agent is infused through a small tube...
What is the current status of trial NCT01502917?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-12. Estimated completion is 2022-01.
What conditions does trial NCT01502917 study?
This clinical trial studies the following conditions: Brain Cancer, Brain Stem Glioma.
What interventions are being tested in trial NCT01502917?
The interventions under investigation include: External Beam Radiotherapy (RADIATION), Radioactive iodine-labeled monoclonal antibody omburtamab (DRUG).
Who is sponsoring clinical trial NCT01502917?
This trial is sponsored by Y-mAbs Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01502917 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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