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OncoMatch/Clinical Trials/NCT02861898

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

Is NCT02861898 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Intra-arterial Cetuximab and Intra-arterial Mannitol for glioblastoma.

Phase 1/2RecruitingNorthwell HealthNCT02861898Data as of May 2026

Treatment: Intra-arterial Cetuximab · Intra-arterial MannitolPrimary 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, 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 EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol). This trial will be a non-randomized open label Phase I/II clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Required: EGFR overexpression

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: chemotherapy

Exception: no chemotherapy for two weeks prior to treatment under this research protocol

No chemotherapy for two weeks prior to treatment under this research protocol

Cannot have received: external beam radiation

Exception: no external beam radiation for eight weeks prior to treatment under this research protocol

no external beam radiation for eight weeks prior to treatment under this research protocol

Cannot have received: chemotherapy or radiation therapy

Patients who initiated or completed chemo/RT

Lab requirements

Blood counts

wbc ≥3000/mm3, absolute neutrophils ≥1500/mm3, platelets ≥100,000/mm3 (≥150,000/mm3 if on coumadin)

Kidney function

creatinine <1.5x iunl

Liver function

bilirubin <1.5x iunl; ast or alt <2.5x iunl

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Lenox Hill Brain Tumor Center · New York, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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