Pilot Trial of Perampanel on Peritumoral Hyperexcitability in Newly Diagnosed High-grade Glioma

Clin Cancer Res. 2024 Dec 2;30(23):5365-5373. doi: 10.1158/1078-0432.CCR-24-1849.

Abstract

Purpose: Glutamatergic neuron-glioma synaptogenesis and peritumoral hyperexcitability promote glioma growth in a positive feedback loop. The objective of this study was to evaluate the feasibility and estimated effect sizes of the targeted AMPA receptor antagonist perampanel on peritumoral hyperexcitability.

Experimental design: An open-label trial was performed comparing perampanel with standard of care (SOC) in patients undergoing resection of newly diagnosed radiologic high-grade glioma. Perampanel was administered as a preoperative loading dose followed by maintenance therapy until progressive disease or up to 12 months. SOC treatment involved levetiracetam for 7 days or as clinically indicated. The primary outcome of hyperexcitability was defined by intraoperative electrocorticography high-frequency oscillation (HFO) rates. Seizure freedom and overall survival were estimated by the Kaplan-Meier method. Tissue concentrations of perampanel, levetiracetam, and correlative biomarkers were measured by mass spectrometry.

Results: HFO rates were similar between patients treated with perampanel and levetiracetam. The trial was terminated early after a planned interim analysis, and outcomes assessed in 11 patients (seven perampanel treated; four treated with SOC). Over a median 281 days of postenrollment follow-up, 27% of patients had seizures, including 14% maintained on perampanel and 50% treated with SOC. Overall survival in perampanel-treated patients was similar to that in a glioblastoma reference cohort. Glutamate concentrations in surface biopsies were positively correlated with HFO rates in adjacent electrode contacts and were not significantly associated with treatment assignment or drug concentrations.

Conclusions: Glioma peritumoral glutamate concentrations correlated with high-gamma oscillation rates. Targeting glutamatergic activity with perampanel achieved similar electrocorticographic hyperexcitability levels as in levetiracetam-treated patients.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Anticonvulsants / pharmacology
  • Anticonvulsants / therapeutic use
  • Brain Neoplasms* / drug therapy
  • Brain Neoplasms* / pathology
  • Electrocorticography
  • Female
  • Glioma* / drug therapy
  • Glioma* / pathology
  • Humans
  • Levetiracetam / therapeutic use
  • Male
  • Middle Aged
  • Neoplasm Grading
  • Nitriles* / therapeutic use
  • Pilot Projects
  • Pyridones* / administration & dosage
  • Pyridones* / therapeutic use
  • Receptors, AMPA / antagonists & inhibitors
  • Receptors, AMPA / metabolism
  • Seizures / drug therapy
  • Treatment Outcome

Substances

  • perampanel
  • Pyridones
  • Nitriles
  • Levetiracetam
  • Anticonvulsants
  • Receptors, AMPA