Actively Recruiting
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
Led by Northwell Health · Updated on 2026-04-13
37
Participants Needed
1
Research Sites
1043 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older
- Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligoastrocytoma
- Pathology confirmed EGFR overexpression
- At least one confirmed and evaluable tumor site proven by biopsy
- Karnofsky performance status of 60% or higher
- Expected survival of at least three months
- No chemotherapy within two weeks prior to treatment
- No external beam radiation within eight weeks prior to treatment
- Adequate blood counts: WBC ≥3000/mm3, neutrophils ≥1500/mm3, platelets ≥100,000/mm3 (≥150,000/mm3 if on Coumadin)
- Chemistry tests within limits: bilirubin <1.5 times upper limit, AST/ALT <2.5 times upper limit, creatinine <1.5 times upper limit
- Coagulation tests (PT and PTT) ≤1.5 times upper limit
- Agree to use effective contraception during treatment and for three months after
- Able to understand and provide written informed consent
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Women of childbearing potential and fertile men who do not agree to use effective contraception during and for three months after treatment
- Significant medical or psychiatric conditions increasing risk or affecting treatment compliance
- Radiological evidence of leptomeningeal disease
- History of allergic reaction to Cetuximab
- Completed chemotherapy or radiation therapy less than six months before enrollment
- Have not failed the standard Stupp protocol treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10075
Actively Recruiting
Research Team
J
John Boockvar, MD
CONTACT
T
Tamika Wong, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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