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

Part of paid clinical trials in Fairfax, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT07831369
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 98 Years
Healthy Volunteers
Not accepted

Interventions

  • Valproic Acid (VPA) — DRUG
    Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
  • Irinotecan — DRUG
    D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily
  • Simvastatin — DRUG
    Day3-21 Continuous simvastatin starting at 40mg daily PO

Study Details

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

Key Dates

First listed
Sep 21, 2026
Start date
Sep 4, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2027
Completion
Dec 30, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Schar CancerFairfaxVirginia22031
Keary Jane't
keary.jane'[email protected]
571-472-3173
Takada Harris
[email protected]
(571) 472-0618

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Inova Schar Cancer· Fairfax, VA

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