Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia
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.
研究概览
详细说明
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.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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Alberta
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Calgary、Alberta、加拿大、T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Edmonton、Alberta、加拿大、T6G 1Z2
- Cross Cancer Institute
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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H 1V7
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton、Ontario、加拿大、L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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London、Ontario、加拿大、N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Toronto、Ontario、加拿大、M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal、Quebec、加拿大、H1T 2M4
- Maisonneuve-Rosemont Hospital
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大、S7N 4H4
- Saskatoon Cancer Centre
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Illinois
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Hinsdale、Illinois、美国、60521
- Hinsdale Hematology Oncology Associates
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104-4283
- Abramson Cancer Center at the University of Pennsylvania
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- See Disease Characteristics
- Absolute granulocyte count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- 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
- At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered
- No prior radiotherapy to more than 25% of bone marrow
Surgery
- At least 4 weeks since prior major surgery
Other
- At least 4 weeks since prior plasmapheresis
- At least 4 weeks since prior investigational anticancer therapy
- No other concurrent investigational anticancer agents or therapies
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
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 |
---|---|---|
Response rate
大体时间: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
|
4 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Toxicity
大体时间:4 years
|
To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.
|
4 years
|
Cytogenetics and genome profiling
大体时间:4 years
|
To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
|
4 years
|
合作者和调查者
调查人员
- 学习椅:Christine I. Chen, MD、Princess Margaret Hospital, Canada
出版物和有用的链接
一般刊物
- Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12.
- Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004.
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
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