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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)
Must not have
Women who are pregnant or lactating
Patients who initiated or completed chemo/RT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant or breastfeeding.
Select...
I have started or finished chemotherapy or radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS)
Progression Free Survival (PFS)
Secondary study objectives
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
473 Previous Clinical Trials
472,239 Total Patients Enrolled
16 Trials studying Glioblastoma
840 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been newly diagnosed with glioblastoma multiforme.My blood counts meet the required levels for treatment.My cancer shows high levels of EGFR.I am currently pregnant or breastfeeding.I have at least one tumor that can be measured and has been confirmed by a biopsy.I haven't had chemotherapy in the last 2 weeks or radiation in the last 8 weeks.I can care for myself and am expected to live for at least three more months.I have started or finished chemotherapy or radiation therapy.I do not have any major health or mental conditions that would make treatment risky for me.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Intra-arterial Cetuximab after BBBD
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Glioblastoma Patient Testimony for trial: Trial Name: NCT02861898 — Phase 1 & 2
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