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Monoclonal Antibodies
Intra-arterial Cetuximab + Intra-arterial Mannitol + Hypofractionated re-irradiation for Brain Tumor
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 with pathology confirmed histologic EGFR overexpression
Must not have
Be younger than 18 years old
Timeline
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 belowSelect...
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.
Select...
You have been diagnosed with a specific type of cancer that shows high levels of EGFR.
Select...
You need to have at least one confirmed and measurable tumor.
Select...
You must be able to perform daily activities at least 60% of the time and have an expected survival of at least three months.
Select...
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.
Select...
Your blood tests must show that your bilirubin, AST or ALT, and creatinine levels are not too high.
Select...
Your blood clotting tests should not be more than 1.5 times the normal range before enrolling in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have signs of leptomeningeal disease on imaging tests.You have had an allergic reaction to CTX in the past.You finished chemotherapy or radiation treatment less than 6 months ago.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.You have not already tried the standard treatment known as the Stupp protocol.
Research Study Groups:
This trial has the following groups:- Group 1: Intra-arterial Cetuximab with Re-Irradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
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:
- Lenox Hill Brain Tumor Center: < 48 hours
Average response time
- < 2 Days
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