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

NCT02800486 | Recruiting Phase 2

• 1 other identifier: HS16-0181
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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; Glioma; Brain Tumor; Brain Tumor, Recurrent; Anaplastic Oligoastrocytoma; Brain Neoplasm; Brain Cancer; Brain Neoplasm, Malignant

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  The 6-month PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.

  6 months

• Overall Survival (OS)

  OS will be calculated as the time from treatment initiation to the date of death.

  2 years

Secondary Outcomes (2)

• Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)

  6 months

• Toxicities graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03

  6 months

Study Arms (1)

Intra-arterial Cetuximab with Re-Irradiation

EXPERIMENTAL

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

Drug: Intra-arterial Cetuximab; Drug: Intra-arterial Mannitol; Radiation: Hypofractionated re-irradiation

Interventions

Intra-arterial Cetuximab DRUG

Intra-arterial Cetuximab with Re-Irradiation

Intra-arterial Mannitol DRUG

Intra-arterial Cetuximab with Re-Irradiation

Hypofractionated re-irradiation RADIATION

Intra-arterial Cetuximab with Re-Irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Brain Tumor Center

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John Boockvar, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Boockvar, MD

CONTACT

212-434-3900; jboockvar@northwell.edu

Tamika Wong, MPH

CONTACT

212-434-4836; twong4@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 15, 2016
• Study Start: May 1, 2016
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2036
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)