VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-98
SponsorInova Health Care Services
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Valproic Acid (VPA)
DrugDay 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
Irinotecan
DrugD2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily
Simvastatin
DrugDay3-21 Continuous simvastatin starting at 40mg daily PO
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: GlioblastomasExperimental treatment 3 interventions
Group B: IDH mutated gliomasExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma
The response is defined as a confirmed complete response (CR) or partial response (PR) defined by RANO 2.0. Response rate will be calculated as the number of observed response (PR or CR) divided by all treated subjects in the arm.
Time frame
through study completion, an average of 6 months from start of treatmentSecondary outcomes
1
Assessing Safety and Adverse Event Rates Of Valproic Acid, Irinotecan, And Simvastatin in Recurrent Glioma
Adverse events will be reported for all patients who receive at least one dose of study medicine.
Time frame
through end of study, average 9 months from start of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov