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

Sponsor: Inova Health Care Services

Sponsor score: 0

ClinicalTrials ID:NCT07831369

This trial assesses valproic acid, irinotecan, and simvastatin in adults with recurrent glioblastoma or IDH-mutated gliomas. Participants must have prior treatment and evidence of progression. The regimen includes 21-day cycles with specific dosing: VPA and simvastatin on Day 1, adding irinotecan on Day 2, and continuous simvastatin from Day 3-21. Eligibility requires measurable lesions per RANO 2.0 criteria.

Patient Parameters

Program Overview

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

Description

This is a prospective clinical trial in two cohorts of patients, adults with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas.

The study evaluates the efficacy of valproic acid, irinotecan, and simvastatin in recurrent glioma by measuring response rate.

The study treatment is as follow: Study Treatment

  • 21-day cycles
  • D1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
  • D2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV
  • D3-21 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

Locations

FACILITYZIPCITYSTATE
Inova Schar Cancer22031FairfaxVirginia

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