← Back to Search

Monoclonal Antibodies

Intra-arterial Cetuximab for Newly Diagnosed Glioblastoma

Phase 1 & 2
Recruiting
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 pathology confirmed histologic EGFR overexpression
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is a study to see if a new treatment for brain cancer is safe and effective. The new treatment is a combination of standard chemotherapy and radiation therapy, with an additional drug given through a direct infusion into the brain.

Who is the study for?
This trial is for adults over 18 with newly diagnosed glioblastoma multiforme (GBM) showing high levels of EGFR. Participants must have good organ function, no recent chemo or radiation, and a life expectancy of at least three months. They should be able to perform daily activities well (Karnofsky score ≥70%) and not be pregnant or breastfeeding. Contraception use during the study and for three months after is required.Check my eligibility
What is being tested?
The trial tests repeated intra-arterial infusions of Cetuximab combined with standard chemoradiation on patients with GBM after disrupting the blood-brain barrier. It's an open-label Phase I/II trial where patients receive three doses post-surgery alongside their regular treatment protocol.See study design
What are the potential side effects?
Previous trials suggest that intra-arterial Cetuximab is generally well-tolerated with few adverse effects reported. However, potential side effects may include allergic reactions, issues related to infusion, and typical chemotherapy-associated risks like fatigue or lowered blood counts.

Eligibility Criteria

Inclusion Criteria

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

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
Heart rate
Toxicities graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intra-arterial Cetuximab after BBBDExperimental Treatment2 Interventions
Mannitol 20% 12.5ml over two minutes for Blood Brain Barrier (BBB) disruption followed by CTX administered intra-arterially for three doses at a dose of 250mg/m2

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
460 Previous Clinical Trials
471,010 Total Patients Enrolled
16 Trials studying Glioblastoma
840 Patients Enrolled for Glioblastoma

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02861898 — Phase 1 & 2
Glioblastoma Research Study Groups: Intra-arterial Cetuximab after BBBD
Glioblastoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT02861898 — Phase 1 & 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02861898 — Phase 1 & 2
Glioblastoma Patient Testimony for trial: Trial Name: NCT02861898 — Phase 1 & 2

Frequently Asked Questions

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

Are new participants being sought for this experiment?

"Yes, this is an active trial that began recruiting on June 1st, 2016 according to the information available on clinicaltrials.gov. The page was last updated on October 27th, 2021."

Answered by AI

How many people are being asked to participate in this experiment?

"That is correct. The listing on clinicaltrials.gov says that the trial is presently looking for 33 patients at 1 location, and has been doing so since it was originally posted on 6/1/2016."

Answered by AI

What are some potential applications for Intra-arterial Cetuximab?

"The glucose tolerance test is a condition that can be effectively managed with Intra-arterial Cetuximab. This treatment method is also useful for other medical conditions, including but not limited to radiation therapy, glomerular filtration rate measurement, and kidney failure, acute."

Answered by AI

Are there precedents for using Intra-arterial Cetuximab in clinical trials?

"As of the current moment, there are one hundred and forty-six separate clinical trials researching Intra-arterial Cetuximab. Thirty-five of those active studies are in Phase 3. While the many trials for Intra-arterial Cetuximab are based in Dresden and Arizona, there are five thousand seven hundred and eleven locations running trials for this treatment globally."

Answered by AI

Have similar clinical trials been conducted in the past?

"There are currently 146 ongoing clinical trials worldwide for Intra-arterial Cetuximab, which was first trialed in 2005. The initial Phase 2 trial, sponsored by Bristol-Myers Squibb, included 154 patients and completed drug approval in 2005. Since then,436 additional trials have been conducted."

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
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I wan to live.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
John Boockvar, MD Zucker SOM @Hofstra/Northwell 2016. "Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02861898.
All > Glioblastoma New York > Glioblastoma Multiforme
~5 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top