EUCTR2012-000091-41-GB进行中（未招募）1 期
A randomised phase 2 trial investigating the additional benefit of hydroxychloroquine(HCQ) to short course radiotherapy (SCRT) in patients aged 70 years and older with high grade gliomas (HGG) - Hydroxychloroquine Trial (HCQ)
niversity College London0 个研究点目标入组 57 人开始时间: 2012年7月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Male and female patients aged =70 yrs identified through the neuro-oncology MDT
- •A histological diagnosis of HGG, either from biopsy or resection.
- •A life expectancy of > 2 months
- •An ECOG performance status of 0/1
- •Absolute neutrophil count = 1.5 x 10^9 L
- •Platelet count = 100 x 10^9 L
- •Bilirubin = 1.5 mg/dL (or = 25.6 micromol/L)
- •Creatinine = 2 times upper limit of normal (ULN)
- •ALT and AST = 4 times ULN
- •Mini Mental Status Exam score = 17
- •Written informed consent
- •Ready to start radiotherapy within 4 weeks of surgery
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •Concurrent psoriasis unless the disease is well controlled and patient is under the care of a specialist for the disorder who agrees to monitor for exacerbations
- •Prior macular degeneration or diabetic retinopathy
- •Concurrent serious infection or medical illness that would preclude study therapy
- •Another malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
- •Glucose- 6 phosphate dehydrogenase (G6PD) deficiency
- •Alcoholic liver disease
- •Any other concurrent severe/uncontrolled medical conditions
- •Currently taking amiodarone
- •Prior radiotherapy, chemotherapy, immunotherapy, biologic agents (e.g. immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumour-infiltrating lymphocytes, lymphokine-activated killer cell therapy, or gene therapy), or hormonal therapy for brain tumour
- •Prior polifeprosan 20 with carmustine implant (Gliadel wafer) or GliaSite® brachytherapy
- •Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (e.g. phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
- •Other concurrent chemotherapeutic or investigational agents for this cancer (Concurrent glucocorticoids will be allowed)
- •Documented side effects to chloroquine or related agents.
- •Unable to give informed consent
- •Patients with a history of a psychological illness or condition that in the opinion of the investigator may adversely affect compliance with study medication
研究者
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