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

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

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Inova Schar Cancer, Fairfax, Virginia · Recruiting