NL-OMON44953已完成不适用
A phase I trial for the addition of chloroquine, an autophagy inhibitor, to concurrent chemoradiation for newly diagnosed glioblastoma - Chloroquine for the treatment of glioblastoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically confirmed grade IV supratentorial astrocytoma (glioblastoma multiforme)
- •Tumor tissue available for histopathological analysis (MGMT, EGFRvIII)
- •Diagnosis must have been made by biopsy or resection <= 6 weeks prior to study entry
- •18 - 70 years
- •Karnofsky performance status >=70
- •Absolute neutrophil count at least 1.5 x 109/L and platelets at least 100 x109/L
- •Adequate renal function: serum creatinine <= 1.5 x upper limit of normal (UNL)
- •Adequate hepatic function: total bilirubin <= 1.5 x UNL for the instituion; ALT, AST, and alkaline phosphatase <= 3 x UNL for the institution
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Willingness to use contraception by a method that is deemed effective by the Investigator throughout the treatment period and for at least 30 days following the last dose of therapy
- •If female, postmenopausal for at least 2 years, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing an appropriate method of birth control
- •If male, subject must be surgically sterile or practicing an appropriate method of contraception and refrain from sperm donation, from initial drug administration until 90 days after the last dose of study drug:
- •Ability to swallow and take oral medication.
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
排除标准
- •Prior radiotherapy
- •Prior chemotherapy
- •Recent (< 3 months) severe cardiac disease (NYHA class >1) (congestive heart failure, infarction)
- •History of cardiac arrythmia which is symptomatic and requiring treatment, or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
- •Cardiac conduction disturbances or medication potentially causing them
- •Treatment with investigational drugs in 4 weeks prior to or during this study
- •If the subject has clinically significant and uncontrolled major medical condition(s) including but not limited to uncontrolled nausea/vomiting/diarrhea; active uncontrolled infection; psychiatric illness/social situation that would limit compliance with study requirements; any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities
- •Another active malignancy within the past 3 years except for any cancer in situ that the principal investigator considers to be cured
- •Chronic systemic immune therapy (with the exception of corticosteroids)
- •Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs
- •Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Psoriasis or porphyria
- •Known hypersensitivity to 4-aminoquinoline compound
- •Retinal or visual field changes unrelated to the tumor location prior to 4-aminoquinoline compound use
研究者
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