RecruitingPhase 2NCT02800486

Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA

Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma

Sponsor

Northwell Health

Enrollment

37 participants

Start Date

May 1, 2016

Study Type

INTERVENTIONAL

Conditions

Brain Tumor Brain Cancer Glioblastoma Glioma Brain Tumor, Recurrent Anaplastic Astrocytoma Anaplastic Oligoastrocytoma Brain Neoplasm Brain Neoplasm, Malignant

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment for people with aggressive brain cancers — including glioblastoma (GBM) and related tumors — that have come back or stopped responding to prior treatment. A drug called cetuximab is delivered directly into the brain's blood supply through a catheter in a blood vessel, combined with a focused second course of radiation therapy. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of relapsed or treatment-resistant glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), or anaplastic oligoastrocytoma (AOA) - Your tumor has been tested and shows overexpression of a protein called EGFR (a growth-driving protein) - You have at least one measurable tumor site confirmed by biopsy - Your general health score (Karnofsky) is 60% or above and you are expected to live at least 3 more months - You have not received chemotherapy in the last 2 weeks or external beam radiation in the last 8 weeks - Your blood counts are adequate **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your tumor does not show EGFR overexpression - Your blood counts are too low - You have other serious medical conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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