NCT00074178已完成2 期
Combination Chemotherapy (Methotrexate, Cyclophosphamide, And Etoposide Phosphate) Delivered In Conjunction With Osmotic Blood-Brain Barrier Disruption (BBBD), With Intraventricular Cytarabine +/- Intra-Ocular Chemotherapy, In 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
- 22
- 试验地点
- 1
- 主要终点
- Survival as measured by clinical and radiographic response at 5 years after study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, etoposide phosphate, dexamethasone, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain. Giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine in treating patients who have primary CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity and efficacy of methotrexate, cyclophosphamide, and etoposide phosphate administered in conjunction with osmotic blood-brain barrier disruption and dexamethasone and cytarabine in patients with primary CNS lymphoma.
Secondary
- Determine the ability to recruit an adequate number 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 this patient population.
- Correlate neuropsychological outcomes with neuroimaging (MRI) outcomes in patients treated with this regimen.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma by brain biopsy or cerebrospinal fluid or vitrectomy analysis
- •No more than 90 days since diagnosis
- •No systemic lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-3 OR
- •Karnofsky 40-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hematocrit at least 25% (transfusion allowed)
- •WBC at least 2,500/mm^3
- •Absolute granulocyte count at least 1,200/mm^3
- •Platelet count at least 100,000/mm^3 OR at least lower limit of normal (transfusion independent)
- •Bilirubin no greater than 2.0 times upper limit of normal
- •Creatinine clearance at least 30 mL/min
- •Cardiovascular
- •Adequate cardiac function to tolerate general anesthesia
- •Adequate pulmonary function to tolerate general anesthesia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 2 months before and during study participation
- •No other uncontrolled clinically significant confounding medical condition within the past 30 days
- •No known allergy to study agents
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Single-agent methotrexate administered within the past 14 days allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior cranial or spinal radiotherapy
- •Prior surgery or biopsy allowed
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 after study treatment
次要结局
- Overall survival as measured by clinical and radiographic response
- Progression-free survival as measured by clinical and radiographic response until tumor progression
- Quality of Life (QOL) as measured by EORTC QOL before and after study treatment, every 6 months for 2 years, and then annually
研究者
Edward Neuwelt
Professor
OHSU Knight Cancer Institute
研究点 (1)
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