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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment52 people
  • Recruiting US sites1
  • SponsorInova Health Care Services
  • RegistryNCT07831369

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma: a one-minute explainerNCT078313691 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to 98 Years
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

irinotecan hydrochloride. The hydrochloride salt of a semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata. Irinotecan, a prodrug, is converted to a biologically active metabolite 7-ethyl-10-hydroxy-camptothecin (SN-38) by a carboxylesterase-converting enzyme. One thousand-fold more potent than its parent compound irinotecan, SN-38 inhibits topoisomerase I activity by stabilizing the cleavable complex between topoisomerase I and DNA, resulting in DNA breaks that inhibit DNA replication and trigger apoptotic cell death. Because ongoing DNA synthesis is necessary for irinotecan to exert its cytotoxic effects, it is classified as an S-phase-specific agent. NCI Drug Dictionary

Treatments listed in the registry

  • 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

The study

Treatment groups

Non Randomized · Single Group · masking: None

Glioblastomas (Experimental)

Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO

IDH mutated gliomas (Experimental)

Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO

Goals

What the study measures

Main goals

  • Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma (through study completion, an average of 6 months from start of treatment)

Other goals

  • Assessing Safety and Adverse Event Rates Of Valproic Acid, Irinotecan, And Simvastatin in Recurrent Glioma

Planned enrollment: 52 (estimated).

Where

Recruiting US sites

  • Inova Schar Cancer, Fairfax, Virginia

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Background research

Papers linked by the registry

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 20, 2026. Public record; not medical advice.

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