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NCT02800486 · ClinicalTrials.gov registry record · Phase 2
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
A Phase 2 study of Glioblastoma and Glioma, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT02800486: Recruiting Phase 2 study of Glioblastoma and Glioma, sponsored by Northwell Health.
NCT02800486 is a Phase 2 study of Glioblastoma and Glioma that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 37 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02800486, a Phase 2 study of Glioblastoma and Glioma, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.
Primary Outcome
The 6-month PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
Conditions Studied
Interventions
- DRUG Intra-arterial Cetuximab
- DRUG Intra-arterial Mannitol
- RADIATION Hypofractionated re-irradiation
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-05 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What NCT02800486 shows while recruiting
NCT02800486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (66% lower).
The record links to 9 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Intra-arterial Cetuximab is the first listed.
NCT02800486 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02800486 about?
NCT02800486 is a clinical study titled "Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA". Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the m...
What is the current status of trial NCT02800486?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2016-05. Estimated completion is 2027-05.
What conditions does trial NCT02800486 study?
This clinical trial studies the following conditions: Glioblastoma, Glioma, Brain Tumor, Brain Cancer, Anaplastic Astrocytoma.
What interventions are being tested in trial NCT02800486?
The interventions under investigation include: Intra-arterial Cetuximab (DRUG), Intra-arterial Mannitol (DRUG), Hypofractionated re-irradiation (RADIATION).
Who is sponsoring clinical trial NCT02800486?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02800486 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02800486's enrollment target sits among peer trials
37 112th of 199 higher than 86 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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