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Monoclonal Antibodies

Intra-arterial Cetuximab + Intra-arterial Mannitol + Hypofractionated re-irradiation for Brain Tumor

Phase 2
Led By John Boockvar, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new way to treat brain cancer that involves surgery, radiation, and chemotherapy. The goal is to see if this new method is safe and effective.

Eligible Conditions
  • Brain Cancer
  • Glioblastoma
  • Anaplastic Astrocytoma
  • Brain Tumor
  • Brain Metastases

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have been diagnosed with a type of brain cancer called glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligoastrocytoma that has come back or not responded to treatment.
You have been diagnosed with a specific type of cancer that shows high levels of EGFR.
You need to have at least one confirmed and measurable tumor.
You must be able to perform daily activities at least 60% of the time and have an expected survival of at least three months.
You need to have enough white blood cells, neutrophils, and platelets in your blood. If you are taking Coumadin, you need to have a higher platelet count.
Your blood tests must show that your bilirubin, AST or ALT, and creatinine levels are not too high.
Your blood clotting tests should not be more than 1.5 times the normal range before enrolling in the study.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression Free Survival (PFS)
Secondary outcome measures
Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)
Toxicities graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intra-arterial Cetuximab with Re-IrradiationExperimental Treatment3 Interventions
Mannitol 20% 12.5ml over two minutes for blood brain barrier (BBB) disruption followed by Cetuximab administered intra-arterially for three doses at a dose of 250 mg/m2 combined with hypofractionated re-irradiation

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
449 Previous Clinical Trials
468,328 Total Patients Enrolled
John Boockvar, MD3.916 ReviewsPrincipal Investigator - Northwell Health
Northwell Health
13 Previous Clinical Trials
782 Total Patients Enrolled
5Patient Review
This neurosurgeon is nothing short of a hero. They are a miracle worker.

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02800486 — Phase 2
Brain Cancer Research Study Groups: Intra-arterial Cetuximab with Re-Irradiation
Brain Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT02800486 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02800486 — Phase 2
Brain Cancer Patient Testimony for trial: Trial Name: NCT02800486 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Intra-arterial Cetuximab been the subject of previous research efforts?

"Currently, 129 trials are being conducted to investigate the efficacy of Intra-arterial Cetuximab. 34 of these active studies have moved into Phase 3 - with Dresden and Arizona hosting a large majority of them. However, across the world 5560 different sites are researching this medication."

Answered by AI

Could you please explain the purpose of Intra-arterial Cetuximab?

"Intra-arterial Cetuximab is a traditional medication used to measure glucose tolerance. Additionally, it can be utilized as a treatment for radiation therapy, glomerular filtration rate measurement, kidney failure, and other acute conditions."

Answered by AI

Has Intra-arterial Cetuximab been officially sanctioned by the FDA?

"There is some evidence suggesting Intra-arterial Cetuximab's safety, so it was scored a 2. Unfortunately, there is no prior clinical data to support efficacy at this time."

Answered by AI

How many test subjects are involved in the experiment?

"Affirmative. According to clinicaltrials.gov, this research is actively enrolling participants that meet the criteria; it was first posted on May 1st 2016 and last updated October 17th 2022 in preparation for recruiting 37 people at one location."

Answered by AI

Are there vacancies available for those wishing to participate in this experiment?

"According to clinicaltrials.gov, the trial is still open for patient enrollment and has been so since it was initially posted on May 1st 2016. Its data was last revised October 17th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Lenox Hill Brain Tumor Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

Dr Ellis is my surgeon. He performed a dibulking craniotomy on my left side brain on May 23, 2023 at Lennox. I trust him and Dr. Boockvar.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What are the side effects?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Most responsive sites:
  1. Lenox Hill Brain Tumor Center: < 48 hours
Average response time
  • < 2 Days
~5 spots leftby May 2025