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Super-selective Intra-arterial Cetuximab for Newly Diagnosed Glioblastoma

This study is looking at a new way to treat newly diagnosed glioblastoma, a type of brain cancer. It uses a drug called Cetuximab, delivered directly into the brain's arteries (intra-arterial), along with another drug called Mannitol. Researchers want to see if this treatment can help patients live longer without their cancer getting worse (Progression Free Survival) and improve overall survival. To join, you must be at least 18 years old, have newly diagnosed glioblastoma, and your tumor must show high levels of a specific marker called EGFR. The study plans to enroll 33 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 33 participants. It is not specified if it is a specific phase of study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track how long participants live without their cancer getting worse for 6 months, and overall survival for 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.

NCT02861898

Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Northwell Health
~33 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Intra-arterial CetuximabIntra-arterial Mannitol

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
Brain Cancer
Brain Neoplasm
Brain Tumor
Brain Neoplasm, Malignant
EGFR Gene Overexpression
GBM

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Where it's being run

1 sites across 1 states
New York1

Who to contact

John Boockvar, MD
[email protected]
212-434-4836
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 newly diagnosed glioblastoma multiforme (GBM)
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 ≥70% (or the equivalent ECOG level of 0-2) 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 as to the potential 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 initiated or completed chemo/RT

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.