Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety/Tolerance
研究概览
简要总结
The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.
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
- •Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour
- •CSF flow abnormalities must be excluded
- •Males or females ≥ 18 years of age
- •Karnofsky Performance Status > 50%
- •Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)
排除标准
- •Unresected parenchymal brain metastases with a diameter > 3 cm
- •Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
- •Prior intrathecal chemotherapy
- •Prior treatment with systemic cytarabine or nitrosureas
- •The patient ist pregnant or breast feeding
- •Severe, active co-morbidities
研究组 & 干预措施
Treatment
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
干预措施: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS) (Radiation)
Treatment
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
干预措施: Lomustine (Drug)
Treatment
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
干预措施: Liposomal cytarabine (Drug)
结局指标
主要结局
Safety/Tolerance
时间窗: 30 weeks
The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
次要结局
- Progression(30 weeks)
- Delay of treatments(30 weeks)
- Response rate(30 weeks)
研究者
PD Dr. Martin Glas
Deputy Director Division of Clinical Neurooncology Unit
University Hospital, Bonn