NCT00072449终止2 期
A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins9 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2004年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 9
- 主要终点
- Radiographic Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.
Secondary
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary CNS lymphoma based on 1 of the following:
- •Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or resection
- •Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease
- •Histologically confirmed vitreal lymphoma with measurable intracranial tumor
- •CD20 positive by brain biopsy
- •Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI
- •Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment
- •No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast
- •No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry
- •No ocular lymphoma by slit lamp examination
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin less than 1.5 mg/dL
- •Transaminases less than 4 times upper limit of normal
- •Creatinine less than 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 year after study participation
- •HIV negative
- •Mini mental status examination score at least 15
- •No concurrent serious infection
- •No other medical illness that would preclude study treatment
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 90 days since prior biologic therapy
- •No prior rituximab
- •No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy
- •Not specified
- •Recovered from prior therapy
- •More than 90 days since prior investigational drugs
- •More than 90 days since prior use of a therapeutic device
排除标准
- 未提供
研究组 & 干预措施
Rituximab monotherapy
Experimental
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
干预措施: rituximab (Biological)
结局指标
主要结局
Radiographic Response
时间窗: 1 month, 2 months and then q3months
it at any time point patient progresses no more scans are required, patient is off study
次要结局
- Progression-free Survival(pt had MRI q3months)
- Overall Survival(47 months)
- Toxicity(8 weeks - 2 cycles)
研究者
研究点 (9)
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