NCT00045695已完成2 期
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 24
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.
详细描述
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression, stable disease duration, and response duration in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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:
- •Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis
- •Newly diagnosed or untreated with IgM ≥ 20 g/L OR
- •Previously treated with IgM ≥ 5 g/L
- •Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)
- •Must have 1 or more of the following:
- •Symptomatic lymphadenopathy
- •Hepatomegaly and/or splenomegaly
- •Anemia (i.e., hemoglobin < 11.0 g/dL)
- •Hyperviscosity syndrome
- •No other lymphoproliferative disease including transformed aggressive lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •See Disease Characteristics
- •Absolute granulocyte count ≥ 1,000/mm^3
- •Platelet count ≥ 50,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST or ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No uncontrolled bacterial, fungal, or viral infection
- •No pre-existing sensory or motor neurotoxicity grade 2 or greater
- •No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years
- •No other serious illness or medical condition that would preclude study participation
- •No unreasonable geographical limitations
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Chemotherapy
- •See Disease Characteristics
- •At least 12 weeks since prior rituximab (for patients who have progressed)
- •At least 24 weeks since prior rituximab (for patients who have not progressed)
- •No prior high-dose chemotherapy and stem cell transplantation
- •No prior radioactive monoclonal antibodies
- •Chemotherapy
- •See Disease Characteristics
- •See Biologic therapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No more than 2 prior chemotherapy regimens
- •The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
- •Single-agent rituximab not considered 1 prior regimen
- •No concurrent cytotoxic chemotherapy
- •Endocrine therapy
- •No concurrent corticosteroids
- •Radiotherapy
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate
时间窗: 4 years
To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia
次要结局
- Toxicity(4 years)
- Cytogenetics and genome profiling(4 years)
研究者
研究点 (24)
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