NCT00182637已完成2 期
A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall Response Rate After 2 Courses of Treatment
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell lymphoma.
详细描述
OBJECTIVES:
- Determine the response rates (complete response and partial response) and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month and then at least every 3 months for 2 years or 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cutaneous T-cell lymphoma, including mycosis fungoides/Sézary syndrome
- •Stage IB-IV disease
- •Relapsed or refractory disease OR intolerant to ≥ 1 prior systemic therapy
- •Measurable disease by radiological imaging or clinical finding
- •Age Over 18
- •Performance status Karnofsky 70-100%
- •Hematopoietic
- •WBC > 2,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 75,000/mm^3
- •Hemoglobin > 8.0 g/dL
- •Bilirubin < 2 times upper limit of normal (ULN)
- •AST and ALT < 3 times ULN
- •Creatinine < 1.5 times ULN
- •Creatinine clearance ≥ 30 mL/min
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •More than 3 months since prior high-dose chemotherapy
- •More than 30 days since prior and no other concurrent investigational drugs
排除标准
- •history of myelodysplastic syndromes
- •evidence of CNS disease
- •pregnant or nursing
- •peripheral neuropathy ≥ grade 2
- •hypersensitivity to bortezomib, boron, or mannitol
- •serious medical condition or psychiatric illness that would preclude study participation
- •concurrent immunotherapy
- •concurrent chemotherapy
- •concurrent steroid dose > 10 mg/day of prednisone or its equivalent
- •concurrent radiotherapy
- •concurrent surgery for the malignancy
研究组 & 干预措施
bortezomib
Experimental
干预措施: bortezomib (Drug)
结局指标
主要结局
Overall Response Rate After 2 Courses of Treatment
时间窗: 2 months
次要结局
- Time to Progression(2 years)
- Toxicity(2 years)
研究者
研究点 (1)
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