A Phase II randomised placebo-controlled, double blind, multisite study of Acetazolamide versus placebo for management of cerebral oedema in recurrent and/or progressive High Grade Glioma requiring treatment with Dexamethasone – The ACED trial

The University of Sydney0 sites30 target enrollmentOctober 13, 2015

Overview

No summary available.

Registry

who.int

Start Date

October 13, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\) Adults aged greater than or equal to 18 years;
•2\) Pathological diagnosis of HGG NOTE: HGG includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ependymoma, anaplastic oligoastrocytoma;
•3\) Clinically or radiologically diagnosed progressive, recurrent and/or persistent residual disease;
•4\) Recommencement of dexamethasone, dexamethasone dose increase, or dexamethasone dependent (unable to reduce below 4mg or cease over 8 weeks); for the management of raised ICP (regardless of aetiology);
•5\) Current dexamethasone dose of a minimum of 4mg per day;
•6\) Stable dexamethasone dose (after dose increase or recommencement) for at least 72 hours before randomisation;
•7\) Baseline Karnofsky Performance Status of greater than or equal to 40 at baseline;
•8\) Ability to swallow oral medication;
•9\) Adequate liver function (Bilirubin less than or equal to 2\.5 times upper limit of normal; Alkaline phosphatase, aspartate transaminase and alanine transaminase less than or equal to 3 times upper limit of normal);
•10\) Adequate renal function (creatinine clearance \> 50 ml/min measured using Cockroft\-Gault);

•1\) Confirmed allergy to sulphur (sulfonamides) (acetazolamide is a sulfonamide derivative and cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives can occur);
•2\) Have had any surgery, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 2 weeks prior to start of treatment on this study or who have not recovered from side effects of such therapy;
•3\) No further neurosurgical procedure planned for the next 8 weeks;
•4\) Pre\-existing metabolic acidosis (pH \< 7\.35 and bicarbonate levels \<24 mmol/l);
•5\) History of nephrolithiasis;
•6\) Systolic Blood Pressure \< 100 mmHg;
•7\) Chronic liver disease (Childs class A or above);
•8\) Systemic corticosteroid use (dexamethasone or prednisone/prednisolone) required for any indication other than cerebral oedema;
•9\) Current oral acetazolamide use for any indication;
•10\) Current bevacizumab therapy or use in prior 4 weeks;