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Monoclonal Antibodies

Cetuximab + Reirradiation for Brain Cancer

Phase 2
Recruiting
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 must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with recurrent brain cancers like GBM, AA, or AOA that have high EGFR levels. They must be in good enough health to participate, not have had recent chemo or radiation therapy, and agree to use contraception. Pregnant women and those with severe medical conditions or allergies to Cetuximab are excluded.Check my eligibility
What is being tested?
The study tests if a combination of intra-arterial Cetuximab (a monoclonal antibody) at a specific dose along with hypofractionated re-irradiation can safely treat recurring brain tumors by preventing tumor growth more effectively than current treatments.See study design
What are the potential side effects?
Cetuximab may cause allergic reactions, skin rash, low magnesium levels, and other infusion-related reactions. Re-irradiation might lead to fatigue, hair loss at the treatment site, headaches, nausea and could potentially damage surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of a specific type of brain tumor that has returned or is not responding to treatment.
Select...
I can care for myself and am expected to live for at least three more months.
Select...
I haven't had chemotherapy in the last 2 weeks or radiation in the last 8 weeks.
Select...
My cancer shows high levels of EGFR.
Select...
I have at least one tumor that can be measured and has been confirmed by a biopsy.
Select...
My blood counts meet the required levels for treatment.

Timeline

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

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
461 Previous Clinical Trials
471,074 Total Patients Enrolled
John Boockvar, MD3.916 ReviewsPrincipal Investigator - Northwell Health
Northwell Health
13 Previous Clinical Trials
788 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?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

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
Email
Most responsive sites:
  1. Lenox Hill Brain Tumor Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
John Boockvar, MD Zucker SOM @Hofstra/Northwell 2016. "Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02800486.
All > Glioblastoma New York > Anaplastic Astrocytoma
~4 spots leftby May 2025
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