NCT07831369PHASE2Recruiting

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

Inova Health Care Services

Start Date

9/4/2026

Completion Date

12/30/2030

Summary

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

Detailed 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

Age Range: 18 years to 98 years

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

Interventions

DRUG

Valproic Acid (VPA)

DRUG

Irinotecan

DRUG

Simvastatin

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Conditions

GlioblastomaAstrocytoma, IDH-Mutant, Grade 4

Locations

Inova Schar Cancer

Fairfax, Virginia 22031

United States