Study on Repeated Intra-arterial Infusion of Cetuximab for Treating Newly Diagnosed Glioblastoma

Sponsor: Northwell Health

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02861898

Provider View

This clinical trial is testing a new method of delivering the drug Cetuximab directly into the brain's arteries to treat newly diagnosed glioblastoma, a common and aggressive form of brain cancer. The study aims to see if this approach, combined with standard treatments, is safe and effective.

Patient Parameters

Program Overview

Glioblastoma is a severe type of brain cancer affecting many people each year. Current treatments, including surgery, radiation, and chemotherapy, often aren't enough, as the survival rate remains low. This study is exploring a new treatment method where the drug Cetuximab is delivered directly into the brain's arteries after temporarily opening the blood-brain barrier. This method has shown promise in earlier studies for recurrent glioblastoma. The trial will test if this approach is safe and effective for patients with newly diagnosed glioblastoma when combined with standard treatments. Participants will receive three doses of Cetuximab at specific times after surgery, along with their regular chemotherapy and radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with glioblastoma multiforme (GBM).
  • Tumor shows high levels of a protein called EGFR.
  • At least one tumor that can be measured and confirmed by a biopsy.
  • Good overall health with a performance status of 70% or higher.
  • Expected to live at least three more months.
  • No chemotherapy for two weeks and no radiation for eight weeks before starting the study.
  • Healthy blood cell counts and liver and kidney function.
  • Willing to use effective birth control during and for three months after treatment.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Individuals who cannot use effective birth control during and for three months after treatment.
  • Those with serious medical or mental health conditions that could interfere with the study.
  • Evidence of cancer spread to the brain's lining.
  • History of allergic reactions to Cetuximab.
  • Have already started or completed chemotherapy or radiation therapy.

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