NCT00030875已完成2 期
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.
详细描述
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma.
- Determine the toxicity of this drug in these patients.
- Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients.
- Determine the time to progression and response duration in patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy until disease progression or for 2 courses beyond documentation of stable PR.
Patients are followed at 4 weeks and then every 3 months until disease progression.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma
- •No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy
- •At least 1 bidimensionally measurable disease site*
- •Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR
- •Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: *Bone lesions are not considered bidimensionally measurable disease
- •No pre-existing ascites or pleural effusion
- •No known CNS involvement by lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 75,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST or ALT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •LVEF at least 45% by echocardiogram or MUGA
- •No pre-existing shortness of breath greater than grade 1
- •No uncontrolled bacterial, fungal, or viral infections
- •No pre-existing edema greater than grade 1
- •No pre-existing neuropathy greater than grade 1
- •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other serious illness or medical condition that would preclude study compliance
- •No geographical conditions that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Chemotherapy
- •Prior rituximab allowed
- •No prior radioactive monoclonal antibody therapy
- •Chemotherapy:
- •See Disease Characteristics
- •No prior high-dose chemotherapy with stem cell transplantation
- •No more than 2 prior systemic chemotherapy regimens
- •Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
- •No prior flavopiridol
- •At least 6 weeks since prior chemotherapy
- •No concurrent cytotoxic chemotherapy
- •Endocrine therapy:
- •No concurrent corticosteroids
- •Radiotherapy:
- •No prior radiotherapy to 25% or more of functioning bone marrow
- •At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered
- •No concurrent radiotherapy to the sole site of measurable disease
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (10)
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