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RECRUITING Phase 2 ClinicalTrials.gov

VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma

Sponsor: Inova Health Care Services • ClinicalTrials.gov ID: NCT07831369

Registry updated: 2026-09-21
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Description

The goal of this clinical trial is to see if the combination of valproic acid, irinotecan, and simvastatin causes these tumors to stabilize or shrink, which is a sign that these combinations are effective against tumors in patients with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas

Interventions

  • Valproic Acid (VPA) (Drug)
    Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
  • Irinotecan (Drug)
    D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily
  • Simvastatin (Drug)
    Day3-21 Continuous simvastatin starting at 40mg daily PO

Eligibility criteria

Inclusion Criteria: * Diagnosis of glioblastoma or IDH-mutated glioma by WHO 2021 classification * For glioblastoma, at least one prior treatment, which needs to include temozolomide and/or radiation * For IDH-mutated glioma, prior treatment with both radiation and alkylating chemotherapy * Evidence of progression by RANO 2.0 criteria on MRI within last four weeks * At least 1 enhancing measurable lesion Exclusion Criteria: * Use of an enzyme-inducing antiepileptic or other strong inducer of CYP3A4 * Prior treatment with irinotecan * Prior use of valproic acid within 2 months * Anticancer treatment within 4 weeks, 6 weeks if nitrosourea * Active bacterial or fungal infection requiring systemic treatment * Pregnancy * Known mitochondrial disease

Conditions

Glioblastoma Astrocytoma, IDH-Mutant, Grade 4

Locations

  • Inova Schar Cancer — Fairfax, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record