NCT00262873已完成2 期
A Phase II Pilot Study of VELCADE in Patients With MDS
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
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced an Adverse Event
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer 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 myelodysplastic syndromes.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of bortezomib, in terms of reduced cytopenia, in patients with myelodysplastic syndromes.
- Determine the safety and toxic effects of this drug in these patients.
Secondary
- Determine changes in marrow blast percentage or karyotypic profile in patients treated with this drug.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bortezomib
Experimental
干预措施: bortezomib (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event
时间窗: For 21 days/course for up to 12 courses
Number of Participants Who Experienced Cytopenias
时间窗: 21 Days/course for up to 12 courses
次要结局
- Vascular Endothelial Growth Factor (VEGF) Levels in Serum(day 14)
- Interleukin 6 Levels in Serum(day 14)
- Average Percentage of Light Density Cells in Apoptosis(day 14)
- Average Number of Colony Forming Unit-granulocyte-macrophages in Bone Marrow(day 14)
- Average Number of Erthroid Burst Forming Units in Bone Marrow(day 14)
- Average Number of Leukemia Forming Units in Bone Marrow(day 14)
研究者
Jane Liesveld
attending physician
University of Rochester
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin LymphomaLymphomaNCT00863369City of Hope Medical Center33
已完成
2 期
Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's LymphomaLymphomaNCT00262860University of Rochester18
终止
2 期
Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's LymphomaLymphomaNCT00265928University of Virginia46
已完成
2 期
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell LymphomaLymphomaNCT00182637Jonsson Comprehensive Cancer Center5
已完成
2 期
Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or GliosarcomaBrain and Central Nervous System TumorsNCT00998010Jonsson Comprehensive Cancer Center24