ACTRN12615001072505终止2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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);
- •11. Adequate haematological function (Neutrophils greater than or equal to 1.0x10^9 cells/L, Platelets greater than or equal to 100x10^9 cells/L)
- •12. Serum sodium greater than or equal to 130 mmol/L;
- •13. Serum potassium between 3-5mmol/L
- •14. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
- •15. Ability to complete patient-reported measures (in English), or if unable a caregiver who can complete caregiver questionnaires;
- •16. Signed, written informed consent;
- •17. Concurrent salvage single or multiple agent chemotherapy including temozolomide (any schedule), carboplatin, a nitrosurea (e.g. CCNU), or etoposide, is permissible.
排除标准
- •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;
- •11) Current salvage re-irradiation;
- •12) Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
- •13) Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 10 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
研究者
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