RECRUITING

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

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Conditions

GlioblastomaAnaplastic AstrocytomaAnaplastic OligoastrocytomaGliomaBrain NeoplasmBrain CancerBrain TumorBrain Tumor, RecurrentBrain Neoplasm, Malignant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-05
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02800486

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patients of ≥18 years of age
  2. * Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)
  3. * Patients with pathology confirmed histologic EGFR overexpression
  4. * Patients must have at least one confirmed and evaluable tumor site.∗
  5. * Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.
  6. * 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
  7. * 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
  8. * 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
  9. * Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL
  10. * 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
  11. * Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening
  1. * Women who are pregnant or lactating.
  2. * 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
  3. * 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
  4. * Patients with radiological evidence of leptomeningeal disease
  5. * Patients with history of allergic reaction to CTX
  6. * Patients who completed chemo/RT less than 6 months prior to enrollment
  7. * Patients who have not failed standard Stupp protocol

Contacts and Locations

Study Contact

John Boockvar, MD
CONTACT
212-434-3900
jboockvar@northwell.edu
Tamika Wong, MPH
CONTACT
212-434-4836
twong4@northwell.edu

Principal Investigator

John Boockvar, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Lenox Hill Brain Tumor Center
New York, New York, 10075
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • John Boockvar, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05
Study Completion Date2026-05

Study Record Updates

Study Start Date2016-05
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

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