NCT04674527Unknown2 期
A Pilot Study of Elemene Injectable Emulsion in Treating Patients With Refractory Glioblastoma
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- overall survival(OS)
研究概览
简要总结
This is a pilot phase I study to evaluate the safety and efficacy on elemene injectable emulsion in treating patients with glioblastoma. Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo.Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs.
详细描述
Background
- Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo
- The study shows that the methodological quality of RCTs of Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs
Objectives
- To evaluate the safety of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ
- To evaluate the efficacy of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years; Male or Female.
- •Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.
- •≥ 8 weeks after completion of front-line radiation therapy
- •≥ 6 weeks after completion of nitrourea chemotherapy
- •≥ 14 days after completion of Temozolomide or other chemotherapy
- •2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline
- •White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
- •Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
- •Patients must be able to understand the investigational nature of the study and provide informed consent.
排除标准
- •Those who are allergic constitution, or have contraindications to CT and MRI1 contrast agents.
- •Those who plan to receive any other anti-tumor treatment during the trial.
- •Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
- •Patients with other malignant tumors.
- •Those with active infections, etc.
- •Suspected or confirmed a history of alcohol and drug abuse.
- •Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
- •Women who are pregnant or nursing.
- •Women of childbearing age who refuse to contraception.
- •Active participation in another clinical treatment trials.
- •According to the judgment of the investigator, other conditions that the plan cannot be followed.
研究组 & 干预措施
experimental group
Experimental
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.And elemene injectable emulsion will be given for 80 -120 ml/day in each 14-day cycle or 21-day cycle.
干预措施: Elemene (Drug)
experimental group
Experimental
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.And elemene injectable emulsion will be given for 80 -120 ml/day in each 14-day cycle or 21-day cycle.
干预措施: Temozolomide (Drug)
contral group
Experimental
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.
干预措施: Temozolomide (Drug)
结局指标
主要结局
overall survival(OS)
时间窗: 2 years.
Kaplan Meier methods will be used to estimate median OS.
progression-free survival(PFS)
时间窗: 2 years.
Kaplan Meier methods will be used to estimate median PFS. Progression is defined by Response Assessment in Neuro-Oncology (RANO) criteria.
次要结局
- complete response(CR)(2 years,up to 15 years if necessary.)
- partial response(2 years,up to 15 years if necessary.)
- objective response rate(ORR)(2 years,up to 15 years if necessary.)
- duration of response(2 years,up to 15 years if necessary.)
研究者
研究点 (1)
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