Study on Valproic Acid, Irinotecan, and Simvastatin for Treating Recurrent Brain Tumors

Sponsor: Inova Health Care Services

Sponsor score: 0

ClinicalTrials ID:NCT07831369

Provider View

This clinical trial is testing a combination of three drugs—valproic acid, irinotecan, and simvastatin—to see if they can help stabilize or shrink tumors in patients with recurrent glioblastoma and certain other brain tumors.

Patient Parameters

Program Overview

The aim of this study is to find out if a combination of valproic acid, irinotecan, and simvastatin can effectively control or reduce the size of tumors in adults with recurrent glioblastoma and IDH-mutated gliomas. Researchers are looking to see if these drugs can help manage the disease in patients whose tumors have returned after previous treatments.

Description

This study involves two groups of patients: adults with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas. The researchers want to see how well the combination of valproic acid, irinotecan, and simvastatin works in controlling these types of brain tumors.

The treatment plan includes:

  • 21-day cycles of medication
  • Day 1: Valproic acid taken twice a day and simvastatin taken once a day
  • Day 2: Valproic acid and simvastatin as on Day 1, plus irinotecan given through an IV
  • Days 3-21: Continue taking simvastatin daily

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma or IDH-mutated glioma according to the latest medical guidelines
  • For glioblastoma patients: Must have had at least one previous treatment, including temozolomide and/or radiation
  • For IDH-mutated glioma patients: Must have had previous treatment with both radiation and a specific type of chemotherapy
  • Evidence of tumor growth on an MRI scan within the last four weeks
  • At least one tumor that can be measured on a scan

Exclusion Criteria

  • Currently using certain medications that affect liver enzymes
  • Have been treated with irinotecan before
  • Have used valproic acid in the last two months
  • Have had any cancer treatment in the last four weeks, or six weeks if it involved a specific type of chemotherapy
  • Have an active bacterial or fungal infection that needs treatment
  • Are pregnant
  • Have a known mitochondrial disease

Locations

FACILITYZIPCITYSTATE
Inova Schar Cancer22031FairfaxVirginia

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