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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: May 2026 to May 2035 Completion date: May 2027 to May 2036v10 Show 1 more changeShow less
    • Completion date: May 2027 to May 2036
  2. Notable Primary completion date: May 2025 to May 2026 Completion date: May 2026 to May 2027v9 Show 1 more changeShow less
    • Completion date: May 2026 to May 2027
  3. Notable Primary completion date: May 2024 to May 2025 Completion date: May 2025 to May 2026v8 Show 1 more changeShow less
    • Completion date: May 2025 to May 2026
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Primary completion date: May 2021 to May 2024 Completion date: May 2022 to May 2025v6 Show 1 more changeShow less
    • Completion date: May 2022 to May 2025
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  1. Minor Re-verified, no change to tracked fieldsv5
  2. Notable Primary completion date: May 2020 to May 2021 Completion date: May 2021 to May 2022v4 Show 1 more changeShow less
    • Completion date: May 2021 to May 2022
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Completion date: May 2021v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT02800486
Lead Sponsor Northwell Health
Conditions Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Glioma, Brain Neoplasm, Brain Cancer, Brain Tumor, Brain Tumor, Recurrent +1 more
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov