Recruiting
Phase 2

Valproic Acid, Irinotecan, Simvastatin

Sponsor:

Inova Health Care Services

Code:

NCT07831369

Conditions

Glioblastoma

Astrocytoma, IDH-Mutant, Grade 4

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Valproic Acid (VPA)

Irinotecan

Simvastatin

Study Details

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

Conditions

Glioblastoma

Astrocytoma, IDH-Mutant, Grade 4

Study ID

NCT07831369

Start date

Sep 4, 2026

Status verified date

Sep, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

52 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Valproic Acid (VPA)

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

Irinotecan

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

Simvastatin

Day3-21 Continuous simvastatin starting at 40mg daily PO

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Keary Jane't

(571) 472-3173keary.jane't@inova.org

Takada Harris

(571) 472-0618takada.harris@inova.org

Locations

Inova Schar Cancer

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Keary Jane't

571-472-3173keary.jane't@inova.org

Takada Harris

(571) 472-0618takada.harris@inova.org

More Information

Sponsor

Inova Health Care Services

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.