Phase I Randomised Multi-centre Study to Demonstrate the Safety of WBRT Concomitant to Intrathecal Liposomal Cytarabine (DepoCyte®) Versus WBRT & Sequential Intrathecal Liposomal Cytarabine (DepoCyte®) for Treatment of STNM With or Without Brain Metastasis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- To demonstrate that WBRT concomitant to DepoCyte is as safe as WBRT & sequential DepoCyte in treating solid tumour neoplastic meningitis with/without brain metastasis.
研究概览
简要总结
The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same time as WBRT with giving the drug after WBRT is complete.
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
- 未提供
排除标准
- •Previous WBRT
- •Brain metastases more than 3 cm diameter
- •Previous IT treatment
- •Uncontrolled infection including HIV infection
- •Any present condition that is regarded as contraindication for WBRT and intrathecal chemotherapy
- •Prior treatment with systemic ARA-C
- •Anticipated hypersensitivity to DepoCyte or ARA-C
- •Clinically manifest encephalopathy
- •On anticoagulant therapy
- •Ventricular peritoneal CSF drain in situ
- •Subjects unable to comply with study procedures
- •Pregnancy and lactation Any other investigational drug administered within 21 days prior to study entry
研究组 & 干预措施
Whole brain radiotherapy (WBRT) with concomitant Depocyte
Subjects will receive a total of 38.4 Gray (Gy) WBRT given over 4 weeks. Subjects will receive 3 GyWBRT on Days 1 and 2 and then 1.8 Gy on the third fourth and fifth days of WBRT treatment during Week 1. Subjects will then receive 1.8 Gy WBRT per day; 5 days out of seven, each week for the next 3 weeks. A total of 4 doses of DepoCyte (50 mg of liposomal ARA-C) will be administered intrathecally. The first dose will be administered on Day 3 (or Day 4 or 5) of Week 1, i.e. the third day of radiotherapy treatment when the dosage is reduced to 1.8 Gy. The second dose will be administered on Day 17(+2 days); the third dose will be administered on Day 31 (+2 days); the fourth dose will be administered on Day 45 (+2 days) to complete the induction phase of the protocol. Subjects will continue to receive an additional 6 doses of DepoCyte one dose every 28 days (+2 days) during the maintenance period. The first dose will be given 28 days after the last dose in the induction phase.
干预措施: Whole brain radiotherapy (WBRT) with concomitant Depocyte (Drug)
Whole Brain Radio Therapy (WBRT) with sequential Depocyte
Subjects will receive a total of 38.4 Gy WBRT given over 4 weeks. Subjects will receive 3 Gy (WBRT on Day 1 and Day 2) and then 1.8 Gy on the third fourth and fifth days of WBRT treatment during Week 1. Subjects will then receive 1.8 Gy WBRT per day; 5 days out of seven, each week for the next 3 weeks. A total of 4 doses of DepoCyte (50 mg of liposomal ARA-C) will be administered intrathecally. The first dose will be administered on Day 29 (+2 days); the second dose will be administered on Day 43(+2 days); the third dose will be administered on Day 57 (+2 days); the fourth dose will be administered on Day 71 (+2 days) to complete the induction phase of the protocol. DepoCyte should never be administered more frequently than every 14th day. Subjects will continue to receive an additional 6 doses of DepoCyte one dose every 28 days (+2 days) during the maintenance period. The first dose will be given 28 days after the last dose in the induction phase.
干预措施: Whole Brain Radio Therapy (WBRT) with sequential Depocyte (Drug)
结局指标
主要结局
To demonstrate that WBRT concomitant to DepoCyte is as safe as WBRT & sequential DepoCyte in treating solid tumour neoplastic meningitis with/without brain metastasis.
时间窗: Safety is reviewed at every visit & for 3 months after last Depocyte administration
次要结局
- Overall survival (OS)(Safety is reviewed at every visit & for 3 months after last Depocyte administration)
- Time to neurologial progression (TNP)(Safety is reviewed at every visit & for 3 months after last Depocyte administration)
- Overall response rate (ORR)(Safety is reviewed at every visit & for 3 months after last Depocyte administration)
- Progression free survival (PFS)(Safety is reviewed at every visit & for 3 months after last Depocyte administration)