NCT00074191已完成2 期
Combination Chemotherapy (Methotrexate, Procarbazine And CCNU), Intraventricular Cytarabine And Methotrexate, +/- Intra-Ocular Chemotherapy For Patients With Primary Central Nervous System Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Survival as measured by clinical and radiographic response at 5 years following completion of study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have primary CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity and efficacy of methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine in patients with primary CNS lymphoma.
Secondary
- Determine the ability to recruit adequate numbers of patients for this study.
- Compare progression-free and dementia-free survival with standard measures of overall survival, progression-free survival, disease-free survival, complete response rate, cognitive function, and quality of life of patients treated with this regimen.
- Determine the feasibility of conducting a future phase III study of this treatment regimen in these patients.
- Correlate neuropsychological outcomes with neuroimaging (MRI) outcomes in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, 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
- 未提供
结局指标
主要结局
Survival as measured by clinical and radiographic response at 5 years following completion of study treatment
时间窗: 5 years
次要结局
- Overall survival as measured by clinical and radiographic response(5 years)
- Progression-free survival as measured by clinical and radiographic response until tumor progression(5 years)
- Quality of Life (QOL) as measured by EORTC QOL before and after study treatment, every 6 months for 2 years, and then annually(5 years)
研究者
Edward Neuwelt
Professor
OHSU Knight Cancer Institute
研究点 (2)
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