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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 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.

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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.

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

FieldValue
Enrollment Target 37 participants
Start Date 2016-05
Est. Completion 2027-05
Phase Phase 2

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT02800486

The ClinicalTrials.gov registry entry for NCT02800486 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (66% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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