NCT00087425已完成2 期
A Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-cell Non Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia
National Institute on Aging (NIA)2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2004年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Feasability and safety
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as bryostatin 1, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Bryostatin 1 may help rituximab kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving bryostatin 1 together with rituximab works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia that has not responded to previous treatment with rituximab.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility and safety of bryostatin 1 and rituximab in patients with rituximab-refractory indolent B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia (CLL).
- Determine the antitumor response in patients treated with this regimen.
Secondary
- Determine the effects of this regimen on the functional and molecular status of effector cells (i.e., NK cells, monocytes, and dendritic cells) in these patients.
- Determine the expression of CD20 and complement-inhibitory molecules on tumor cells before and after treatment with this regimen in these patients.
- Determine the effects of this regimen on the global gene expression pattern in CLL cells of these patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •One of the following histologically or cytologically confirmed diseases:
- •Indolent B-cell non-Hodgkin's lymphoma (NHL)
- •Stage II-IV disease
- •Chronic lymphocytic leukemia (CLL) meeting 1 of the following risk criteria:
- •Intermediate-risk with progressive disease
- •High-risk, modified Rai stage disease
- •CD20-positive by flow cytometry or immunohistochemistry
- •Measurable disease
- •Rituximab-refractory disease, defined as failure to achieve a response to the last course of prior treatment with rituximab alone or in combination with other therapeutic modalities
- •No known neoplastic leptomeningeal involvement and/or brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 50,000/mm^3
- •WBC ≥ 3,000/mm^3
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Bilirubin normal (unless due to Gilbert's disease or organ involvement by NHL or CLL)
- •Creatinine normal OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No history of anaphylaxis or immunoglobulin (Ig) E-mediated hypersensitivity to murine protein
- •Prior infusion reactions to rituximab without an IgE component allowed
- •No active or ongoing infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •See Radiotherapy
- •At least 12 weeks since prior rituximab
- •More than 4 weeks since prior immunotherapy and recovered
- •Chemotherapy
- •No more than 3 prior chemotherapy regimens
- •More than 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy
- •No concurrent glucocorticoids
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Feasability and safety
Antitumor response
次要结局
- Functional and molecular status of effector cells
- Expression of CD20 and complement-inhibitory molecules on tumor cells before and after treatment
- Effects on global gene expression pattern in chronic lymphocytic leukemia cells
研究者
研究点 (2)
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