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.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
37 (estimated)
Sponsor
Northwell Health · Other
Who this trial is looking for
This trial is looking for adults with certain types of recurring brain tumors. Participants will receive a specific treatment and radiation to see if it helps stop the tumor growth.
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 relapsed or refractory glioblastoma or related brain tumors.
I have a confirmed tumor that can be evaluated.
I have a performance status of 60% or higher.
I have not received chemotherapy in the last two weeks.
I have enough healthy blood cells.
I agree to use effective contraception during and after the treatment.
I can give informed consent.
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 have had an allergic reaction to Cetuximab.
I completed chemotherapy or radiation less than 6 months ago.
I have not failed standard treatments.
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 three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Primary 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, afflicting approximately 7,000 patients in the United State…
Primary 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, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male or female patients of ≥18 years of age
* 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 overexpre…
Inclusion Criteria:
* Male or female patients of ≥18 years of age
* 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
* Patients must have at least one confirmed and evaluable tumor site.∗
\*A confirmed tumor site is one in which is biopsy-proven
* Patients must have a Karnofsky performance status ≥60% 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 of the potential unknown 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 completed chemo/RT less than 6 months prior to enrollment
* Patients who have not failed standard Stupp protocol
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