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Phase I and Biomarker Study of Plerixafor and Bevacizumab in Recurrent High-Grade Glioma

Eudocia Q Lee1,2, Dan G Duda2,3, Alona Muzikansky3

  • 1Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. eqlee@partners.org.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|June 27, 2018
PubMed

Insights

This phase I study found that plerixafor and bevacizumab combination therapy is safe and well-tolerated in patients with high-grade glioma (HGG). The treatment showed promising biomarker changes and drug distribution to the central nervous system.

Area of Science:

  • Oncology
  • Pharmacology
  • Neuroscience

Background:

  • Antiangiogenic therapy for high-grade glioma (HGG) shows limited durability.
  • The SDF-1α/CXCR4 axis is implicated in resistance to VEGFR inhibitors.
  • Plerixafor, a CXCR4 inhibitor, demonstrated potential in preclinical models of glioma.

Purpose of the Study:

  • To assess the safety and tolerability of combining plerixafor and bevacizumab in recurrent HGG.
  • To evaluate drug distribution into cerebrospinal fluid (CSF) and tumor tissue.
  • To investigate associated biomarker changes during treatment.

Main Methods:

  • Phase I dose escalation study (Part 1) with 23 HGG patients.
  • Combination therapy: plerixafor (320 μg/kg SC) and bevacizumab (10 mg/kg IV) in 28-day cycles.
  • Pharmacokinetic and biomarker analyses of plasma and CSF; tumor tissue analysis in 3 patients (Part 2).

Main Results:

  • The combination was well-tolerated with no dose-limiting toxicities at the maximum dose.
  • Plerixafor achieved significant concentrations in CSF (26.8 ± 19.6 ng/mL) and tumor tissue (10-12 μg/g).
  • Biomarker analysis revealed increased SDF-1α and placental growth factor; survival correlated with specific cell populations and soluble factors.

Conclusions:

  • Plerixafor and bevacizumab combination therapy is safe and well-tolerated in recurrent HGG patients.
  • Plerixafor effectively penetrates the central nervous system, including brain tumors.
  • The combination induces biomarker changes indicative of VEGF and CXCR4 inhibition, warranting further investigation.

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