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Cetuximab Treatment for Newly Diagnosed Glioblastoma

Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

Recruiting Phase 1 Phase 2 Interventional Study

Glioblastoma Brain Cancer Brain Neoplasm Brain Tumor Brain Neoplasm, Malignant EGFR Gene Overexpression GBM

No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.

At a Glance

Age: 18 and older
Sex: Any
Trial phase: Phase 1/2
Study type: Interventional
Purpose: Treatment
Participants needed: 33 (estimated)
Sponsor: Northwell Health · Other

Who this trial is looking for

This trial is looking for adults diagnosed with newly diagnosed glioblastoma. Participants will receive a treatment called Cetuximab along with standard chemotherapy and radiation therapy after a specific procedure to allow the drug to enter the brain.

Are You a Good Fit for This Trial?

You may be able to join if

I am at least 18 years old.
I have been diagnosed with newly diagnosed glioblastoma.
My tumor shows overexpression of the EGFR gene.
I have a confirmed tumor site from a recent biopsy.
I have a Karnofsky performance status of 70% or higher.
I have not received chemotherapy in the last two weeks.
I have not received radiation therapy in the last eight weeks.
I agree to use effective contraception during the trial.

You may not be able to join if

I am pregnant or breastfeeding.
I have significant medical or psychiatric conditions that affect my treatment.
I have evidence of leptomeningeal disease.
I am allergic to Cetuximab.
I have recently started or completed chemotherapy or radiation therapy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility

About This Trial

Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, aff…

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Eligibility Criteria

Inclusion Criteria: * Male or female patients of ≥18 years of age. * Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM) * Patients with pathology confirmed histologic EGFR overexpression * Patients must have at least one confirmed and evaluable tumor site.∗ \*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study. * Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months. * No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol. * 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 * Pre-enrollment chemistry parameters must show: bilirubin\<1.5X the institutional upper limit of normal (IUNL); AST or ALT\<2.5X IUNL and creatinine\<1.5X IUNL. * Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL. * Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study. * Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening. Exclusion Criteria: * Women who are pregnant or lactating. * Women of childbearing potential and fertile men will be informed as to the potential risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. * Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring * Patients with radiological evidence of leptomeningeal disease. * Patients with history of allergic reaction to CTX * Patients who initiated or completed chemo/RT

Contacts

John Boockvar, MD

212-434-4836

jboockvar@northwell.edu

CONTACT

Tamika Wong, MPH