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Cetuximab and Reirradiation for Relapsed/Refractory Brain Tumors

This study is investigating a new approach for people with relapsed or refractory (meaning it has come back or not responded to previous treatment) glioblastoma, anaplastic astrocytoma, or anaplastic oligoastrocytoma. It combines a drug called Cetuximab (Erbitux), given directly into the arteries, with re-irradiation (another course of radiation therapy). Cetuximab targets a protein called EGFR, which is often found in these types of brain tumors. To join, you must be at least 18 years old, have one of these specific brain tumors that has come back or not responded to treatment, and your tumor must show EGFR overexpression. The study will measure how long patients live without their disease getting worse (Progression Free Survival at 6 months) and how long they live overall (Overall Survival at 2 years). The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 37 participants. The specific phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure how long they live without their disease worsening (6 months) and their overall survival (2 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02800486

Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA

Recruiting
PHASE2Ages 18+InterventionalTreatment
Northwell Health
~37 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Intra-arterial CetuximabIntra-arterial MannitolHypofractionated re-irradiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over 6 months
+1 more outcome measured

Conditions

Glioblastoma
Anaplastic Astrocytoma
Anaplastic Oligoastrocytoma
Glioma
Brain Neoplasm
Brain Cancer
Brain Tumor
Brain Tumor, Recurrent
Brain Neoplasm, Malignant

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • John Boockvar, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

John Boockvar, MD
[email protected]
212-434-3900
Email the study team

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Eligibility criteria

Inclusion

Male or female patients of ≥18 years of age
Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)
Patients with pathology confirmed histologic EGFR overexpression
Patients must have at least one confirmed and evaluable tumor site.∗
Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.
No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol
Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must have a platelet count of ≥150,000/ mm3
Pre-enrollment chemistry parameters must show: bilirubin\<1.5X the institutional upper limit of normal (IUNL); AST or ALT\<2.5X IUNL and creatinine\<1.5X IUNL
Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL
Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study
Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening

Exclusion

Women who are pregnant or lactating.
Women of childbearing potential and fertile men will be informed of the potential unknown risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period
Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring
Patients with radiological evidence of leptomeningeal disease
Patients with history of allergic reaction to CTX
Patients who completed chemo/RT less than 6 months prior to enrollment
Patients who have not failed standard Stupp protocol

What this trial measures

  • Progression Free Survival (PFS)6 months

    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.

  • Overall Survival (OS)2 years

    OS will be calculated as the time from treatment initiation to the date of death.