Clinical trial · Interventional
VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma
NCT07831369CI-TRIAL-00126459recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, IDH-Mutant, Grade 4 | Astrocytoma, IDH-Mutant, Grade 4 | ONTOLOGY_EXACT | 0.98 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Simvastatin | Drug | — | UNRESOLVED |
| Valproic Acid (VPA) | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Glioblastomas
- description
- 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
- interventionNames
- Drug: Valproic Acid (VPA)
- Drug: Irinotecan
- Drug: Simvastatin
- type
- EXPERIMENTAL
- label
- IDH mutated gliomas
- description
- 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
- interventionNames
- Drug: Valproic Acid (VPA)
- Drug: Irinotecan
- Drug: Simvastatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 98 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTFriedman 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 10334539
- RESULTSiegel 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 38230766
- RESULTBlaney 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 9554590
- RESULTHorbinski 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 36634606