the efficacy of histone deacetylase inhibitor valproic acid in the treatment of gliomas

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Addition of oral valproate (dose is epilepsy dose titrated to plasma concentration so changes) or placebo to standard care. start dose is 15‐20mg/kg, titrated in 100‐200mg amounts depending on clinical status. Once daily until completion of second scan after chemotherapy/radiotherapy scan (3‐4 months). VPA commences 4‐5 days pre surgery to enable CSF samples at time of surgery. Blood concentrations to monitor adherence. CONDITION: Brain Cancer PRIMARY OUTCOME: F‐DOPA and F‐MISO PET uptake using standard PET measurement tool SECONDARY OUTCOME: brain tissue for genetic markers known to be associated with survival in brain cancer (e.g. MGMT status and HDAC activity) Blood for measurements of valproate concentration, for HDAC activity in the PBMCs and tumor DNA. Possible side effects technically include any reported for VPA over the last 60 years. However we are recording any complaint as reported by the patient and assessing tolerability throughout study (ie any side effects post reporting or querying at any time point) including ECOG status. INCLUSION CRITERIA: GBM and having surgical therapy Likely to be able to tolerate VPA
Epistemonikos ID: a23972841b458dc1a14d559b07141a560d9f6ab1
First added on: Aug 25, 2024