Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and best ways to give combination chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS lymphoma.
研究概览
详细说明
OBJECTIVES:
Primary
- Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Secondary
- Determine the efficacy of this regimen, in terms of the 4-month and 12-month complete and best response rate, in these patients.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the percentage of patients experiencing toxicity or neurotoxicity due to this regimen.
- Determine the treatment-related mortality rate in patients treated with this regimen.
- Document the neurocognitive changes in these patients using the Mini-Mental Status Examination during the first year of treatment with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive high-dose methotrexate IV over 4 hours on days 1,15, 29, 43, 57, 71, and 99; leucovorin calcium IV every 6 hours on days 2-4, 16-18, 30-32, 44-46, 58-60, 72-74, and 100-102; oral temozolomide on days 7-11, 35-39, 63-67, 91-95, and 119-123; and rituximab IV on days 3, 17, 31, 45, 59, and 74. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response proceed to consolidation therapy.
- Consolidation therapy I: Beginning 3-4 weeks after completing induction therapy, patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin calcium IV every 6 hours on days 2-4, and oral temozolomide on days 7-11.
- Consolidation therapy II: Beginning 3-5 weeks after completing consolidation therapy I, patients receive cytarabine IV over 2 hours twice daily and etoposide phosphate IV continuously on days 1-4 and filgrastim (G-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued to this study.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed untreated primary CNS lymphoma (PCNSL) confirmed by 1 of the following methods:
Brain biopsy or resection
- Patients diagnosed with T-cell PCNSL allowed but will not receive rituximab on study
Cerebrospinal fluid (CSF) cytology
- Positive CSF cytology with or without measurable intracranial disease
Vitreal biopsy
- Histologic confirmation of vitreal lymphoma with measurable intracranial tumor
No evidence of systemic non-Hodgkin's lymphoma
- CT scan of chest, abdomen, and pelvis or bone marrow biopsy negative for extracerebral source of lymphoma
- No evidence of pleural effusions or ascites
- MRI of brain and spine (plus gadolinium) must have measurable contrast enhancing disease unless CSF cytology is positive
PATIENT CHARACTERISTICS:
- Karnofsky performance score 50-100%
- HIV negative
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No concurrent salicylates, nonsteroidal anti-inflammatory drugs, sulfonamides, or penicillins within the past week
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:methotrexate, leucovorin calcium, rituximab, and temozolomide
Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
rate of toxicity in patients with untreated primary CNS lymphoma
大体时间:up to 8 months
|
Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
|
up to 8 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Efficacy in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
大体时间:up to 12 months
|
up to 12 months
|
合作者和调查者
调查人员
- 学习椅:James L. Rubenstein, MD, PhD、University of California, San Francisco
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 神经系统疾病
- 免疫系统疾病
- 组织学类型的肿瘤
- 肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 按部位分类的肿瘤
- 淋巴瘤
- 神经系统肿瘤
- 中枢神经系统肿瘤
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 抗病毒药物
- 核酸合成抑制剂
- 酶抑制剂
- 抗风湿药
- 抗代谢药、抗肿瘤药
- 抗代谢物
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 保护剂
- 抗肿瘤药,烷基化
- 烷化剂
- 抗肿瘤药,植物性
- 拓扑异构酶 II 抑制剂
- 拓扑异构酶抑制剂
- 抗肿瘤药,免疫学
- 皮肤病药物
- 微量元素
- 维生素
- 生殖控制剂
- 解毒剂
- 复合维生素B
- 堕胎药,非甾体
- 堕胎剂
- 叶酸拮抗剂
- 依托泊甙
- 磷酸依托泊甙
- 替莫唑胺
- 利妥昔单抗
- 亚叶酸
- 左旋叶酸
- 阿糖胞苷
- 甲氨蝶呤
其他研究编号
- CDR0000458052
- UCSF-03301
- UCSF-H9414-23160-02A
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