Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Response Rate After 2 Courses of Therapy
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. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochloride.
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bortezomib, Gemcitabine Hdrochloride
干预措施: bortezomib (Drug)
Bortezomib, Gemcitabine Hdrochloride
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Response Rate After 2 Courses of Therapy
时间窗: 21 Days/course for up to 2 courses
Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG-PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG-PET images) to below three on posttreatment FDG-PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).
次要结局
- Change in Proteasome Activity Compared to Baseline (Cycle 1)(baseline to 2 hours)
- Change in Proteasome Activity Compared to Baseline (Cycle 2)(baseline and 1-2 weeks after cycle 2, day 11)
研究者
Jonathan Friedberg
Professor
University of Rochester