Recruiting
Phase 2

Cetuximab with Reirradiation

Sponsor:

Northwell Health

Code:

NCT02800486

Conditions

Glioblastoma

Anaplastic Astrocytoma

Anaplastic Oligoastrocytoma

Glioma

Brain Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intra-arterial Cetuximab

Intra-arterial Mannitol

Hypofractionated re-irradiation

Study Details

Brief 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.

Conditions

Glioblastoma

Anaplastic Astrocytoma

Anaplastic Oligoastrocytoma

Glioma

Brain Neoplasm

Study ID

NCT02800486

Start date

May, 2016

Status verified date

Apr, 2026

Completion date

May, 2036

Anticipated

Primary completion date

May, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intra-arterial Cetuximab with Re-Irradiation

Mannitol 20% 12.5ml over two minutes for blood brain barrier (BBB) disruption followed by Cetuximab administered intra-arterially for three doses at a dose of 250 mg/m2 combined with hypofractionated re-irradiation

Interventions

Intra-arterial Cetuximab

Intra-arterial Mannitol

Hypofractionated re-irradiation

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: 6 months ]
  • Overall Survival (OS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

John Boockvar, MD

212-434-3900jboockvar@northwell.edu

Tamika Wong, MPH

212-434-4836twong4@northwell.edu

Locations

Lenox Hill Brain Tumor Center

Recruiting

New York, New York, United States, 10075

Contacts

John Boockvar, MD

212-434-3900jboockvar@northwell.edu

Tamika Wong, MPH

212-434-4836twong4@northwell.edu

Principal Investigator:

John Boockvar, MD

More Information

Sponsor

Northwell Health

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-04-13.