VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma
1 other identifier
interventional
52
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2026
CompletedFirst Submitted
Initial submission to the registry
September 9, 2026
CompletedFirst Posted
Study publicly available on registry
September 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
September 21, 2026
September 1, 2026
1.1 years
September 9, 2026
September 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma
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 Outcomes (1)
Assessing Safety and Adverse Event Rates Of Valproic Acid, Irinotecan, And Simvastatin in Recurrent Glioma
through end of study, average 9 months from start of treatment
Study Arms (2)
Glioblastomas
EXPERIMENTALDay1 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
EXPERIMENTALDay1 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
Interventions
Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily
Day3-21 Continuous simvastatin starting at 40mg daily PO
Eligibility Criteria
You may qualify 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inova Schar Cancer
Fairfax, Virginia, 22031, United States
Related Publications (4)
Friedman HS, Petros WP, Friedman AH, Schaaf LJ, Kerby T, Lawyer J, Parry M, Houghton PJ, Lovell S, Rasheed K, Cloughsey T, Stewart ES, Colvin OM, Provenzale JM, McLendon RE, Bigner DD, Cokgor I, Haglund M, Rich J, Ashley D, Malczyn J, Elfring GL, Miller LL. Irinotecan therapy in adults with recurrent or progressive malignant glioma. J Clin Oncol. 1999 May;17(5):1516-25. doi: 10.1200/JCO.1999.17.5.1516.
PMID: 10334539RESULTSiegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
PMID: 38230766RESULTBlaney SM, Takimoto C, Murry DJ, Kuttesch N, McCully C, Cole DE, Godwin K, Balis FM. Plasma and cerebrospinal fluid pharmacokinetics of 9-aminocamptothecin (9-AC), irinotecan (CPT-11), and SN-38 in nonhuman primates. Cancer Chemother Pharmacol. 1998;41(6):464-8. doi: 10.1007/s002800050768.
PMID: 9554590RESULTHorbinski C, Nabors LB, Portnow J, Baehring J, Bhatia A, Bloch O, Brem S, Butowski N, Cannon DM, Chao S, Chheda MG, Fabiano AJ, Forsyth P, Gigilio P, Hattangadi-Gluth J, Holdhoff M, Junck L, Kaley T, Merrell R, Mrugala MM, Nagpal S, Nedzi LA, Nevel K, Nghiemphu PL, Parney I, Patel TR, Peters K, Puduvalli VK, Rockhill J, Rusthoven C, Shonka N, Swinnen LJ, Weiss S, Wen PY, Willmarth NE, Bergman MA, Darlow S. NCCN Guidelines(R) Insights: Central Nervous System Cancers, Version 2.2022. J Natl Compr Canc Netw. 2023 Jan;21(1):12-20. doi: 10.6004/jnccn.2023.0002.
PMID: 36634606RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Cohen, MD
Inova Health Care Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2026
First Posted
September 21, 2026
Study Start
September 4, 2026
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
December 30, 2030
Last Updated
September 21, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share