A Phase II Study of PS-341 (Bortezomib) in 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
- 43
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint.
II. To assess time to progression and 2-year overall survival after bortezomib therapy.
III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma.
OUTLINE: This is a multicenter study.
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 classical Hodgkin's lymphoma
- •No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis
- •Core biopsies allowed if they contain adequate tissue for primary diagnosis
- •The following subtypes are allowed:
- •Nodular sclerosis
- •Lymphocyte rich
- •Mixed cellularity
- •Lymphocyte depletion
- •Classical Hodgkin's lymphoma, not otherwise specified
- •No nodular lymphocyte-predominant Hodgkin's lymphoma
- •Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen
- •Measurable disease by physical exam or imaging studies
- •Any tumor mass > 1 cm is allowed
- •No non-measurable disease only, including the following:
- •Bone lesions
- •Pleural or pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Bone marrow
- •No curative option available with high-dose therapy and stem cell transplantation
- •Performance status - 0-2
- •Absolute neutrophil count ≥ 750/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 2.5 times ULN
- •Creatinine ≤ 2.5 mg/dL
- •No sensory or motor peripheral neuropathy ≥ grade 2
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 3 months after study participation
- •See Disease Characteristics
- •Prior stem cell transplantation allowed
- •See Disease Characteristics
- •No concurrent chemotherapy
- •No concurrent dexamethasone or other steroidal antiemetics
- •Concurrent steroids for adrenal failure allowed
- •Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
- •Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present
- •No concurrent palliative radiotherapy
- •Recovered from all prior treatment
- •No prior bortezomib or other proteosome inhibitors
排除标准
- 未提供
研究组 & 干预措施
Arm I
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 rapid disease progression or unacceptable toxicity.
干预措施: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib (Drug)
结局指标
主要结局
Time to progression
时间窗: Up to 5 years
Overall survival
时间窗: 2 years
Overall response rate
时间窗: Up to 3 years
次要结局
未报告次要终点