Clinical Trials

A Pilot Study of Weekly High-Dose Erlotinib for Recurrent High-Grade Gliomas with the EGFR variant III Mutation

Protocol
10-125
Full Title
Pilot Study of EGFR Inhibition Using High Dose Administration of Erlotinib Weekly for Recurrent Malignant Gliomas With EGFR Variant III Mutation
Purpose

Erlotinib is a drug approved for treating advanced lung and pancreatic cancers. It works by blocking a protein called the epidermal growth factor receptor (EGFR), which tells cancer cells to grow. Some gliomas contain an altered form of EGFR called variant number 3 (abbreviated EGFR variant III or EGFRvIII).

Research suggests that erlotinib is particularly effective at stopping EGFRvIII, and that high doses of erlotinib taken once per week may be more effective than low doses taken once daily. The purpose of this study is to evaluate the safety and effectiveness of weekly high-dose erlotinib in patients with high-grade gliomas with an EGFR variant III mutation that persist or recur despite prior therapy.

Investigator
Ingo K. Mellinghoff, MD
Ingo K. Mellinghoff - Physician Profile
Co-Investigators
Christian Grommes, MD
Christian Grommes - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a high-grade glioma with the EGFR variant III mutation that has continued to grow despite therapy.
  • At least 4 weeks must have passed since completion of prior systemic therapy and 3 months since prior radiation therapy to the brain and entry into the study.
  • Patients may not have received prior therapy with Gliadel wafers, catheter-delivered treatments, EGFR inhibitors, or VEGF (vascular endothelial growth factor) inhibitors (such as bevacizumab).
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact the Brain Tumor Hotline at 212-639-6767.

Disease(s)
Brain Tumors, Primary: Gliomas
Pediatric Brain Tumors: Brain Cancer
Locations
ClinicalTrials.gov
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