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

September 15, 2026 updated by: Inova Health Care Services

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glioblastomas

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
Drug: Valproic Acid (VPA)

Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily

Drug: Irinotecan

D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily

Drug: Simvastatin

Day3-21 Continuous simvastatin starting at 40mg daily PO
Experimental: IDH mutated gliomas

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
Drug: Valproic Acid (VPA)

Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily

Drug: Irinotecan

D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily

Drug: Simvastatin

Day3-21 Continuous simvastatin starting at 40mg daily PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma
Time Frame: through study completion, an average of 6 months from start of treatment

The response is defined as a confirmed complete response (CR) or partial response (PR) defined by RANO 2.0. Response rate will be calculated as the number of observed response (PR or CR) divided by all treated subjects in the arm.
through study completion, an average of 6 months from start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing Safety and Adverse Event Rates Of Valproic Acid, Irinotecan, And Simvastatin in Recurrent Glioma
Time Frame: through end of study, average 9 months from start of treatment

Adverse events will be reported for all patients who receive at least one dose of study medicine.
through end of study, average 9 months from start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Adam Cohen, MD, Inova Health Care Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inova-2025-267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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