NCT01575782终止1 期
Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (SCLC) Patients: a Phase I Trial.
Maastricht Radiation Oncology1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
Chloroquine can make tumor cells less resistant to chemo/radiotherapy. In this trial chloroquine is given during radiotherapy. The dose is increased in cohorts of at least 3 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage I-III small cell lung cancer, excluding malignant pleural/pericardial effusion.
- •At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan
- •WHO performance status 0-2
- •Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
- •Adequate renal function: calculated creatinine clearance at least 60 ml/min
- •Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
- •No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
- •Lung function: FEV1 at least 30 % and DLCO at least 30 % of the age predicted value
- •No history of prior chest radiotherapy
- •Life expectancy more than 6 months
- •Willing and able to comply with the study prescriptions
- •18 years or older
- •Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
- •Ability to give and having given written informed consent before patient registration
- •No mixed pathology, e.g. non-small cell plus small cell cancer
- •No recent (< 3 months) severe cardiac disease (NYHA class >1) (congestive heart failure, infarction)
- •No history of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 3.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
- •No cardiac conduction disturbances or medication potentially causing them:
- •QTc interval prolongation with other medications that required discontinuation of the treatment
- •Congenital long QT-syndrome or unexplained sudden death of first degree relative under 40 years of age
- •QT interval > 480 msec (note: when this is the case on screening ECG, the ECG may be repeated twice. If the average QT-interval of these 3 measurements remains below 480 msec, patient is eligible)
- •Patients on medication potentially prolongating the QT-interval are excluded if the QT-interval is > 460 msec (Appendix, table 2).
- •Medication that might cause QT-prolongation or Torsades de pointes tachycardia is not allowed (Appendix, Table 1). Drugs with a risk of prolongating the QT-interval that cannot be discontinued are allowed, however, under close monitoring by the treating physician (Appendix, table 2).
- •Complete left bundle branch block
- •No uncontrolled infectious disease
- •No other active malignancy
- •No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in previous 4 weeks
- •No treatment with investigational drugs in 4 weeks prior to or during this study
- •No chronic systemic immune therapy
- •No known G6PD deficiency
- •Patients must not have psoriasis or porphyria.
- •No known hypersensitivity to 4-aminoquinoline compound.
- •Patients must not have retinal or visual field changes from prior 4-aminoquinoline compound use.
- •No known prior hypersensitivity to cisplatin, etoposide or chloroquine or any of their components.
排除标准
- •The opposite of the above
研究组 & 干预措施
Chloroquine
Experimental
干预措施: Chloroquine (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 3 months after inclusion
次要结局
- Response of the tumour (regression, progression, stable disease)(2 years after inclusion)
- Overall survival(2 years after inclusion)
研究者
研究点 (1)
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