What this study is
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
What's being tested
- Valproic Acid (VPA)
Intervention · DRUG
Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
- Irinotecan
Intervention · DRUG
D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily
- Simvastatin
Intervention · DRUG
Day3-21 Continuous simvastatin starting at 40mg daily PO
Study details
- Sponsor
- Inova Health Care Services
- Conditions
- Glioblastoma · Astrocytoma, IDH-Mutant, Grade 4
- Enrolling
- 52 people
- Starts
- 2026-09-04
- Est. completion
- 2030-12-30
- Design
- Open-label, non-randomized, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 98 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openInova Schar Cancer
Fairfax, Virginia, United States
- Keary Jane't · Contact571-472-3173keary.jane't@inova.org
- Takada Harris · Contact(571) 472-0618takada.harris@inova.org
Recruiting
Study team
Sponsor
Inova Health Care Services
Study ID Inova-2025-267
Principal investigator
Adam Cohen, MD
Inova Health Care Services
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.