NCT00039156Unknown2 期
An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
Theradex30 个研究点 分布在 2 个国家开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 30
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma treated with BAY 59-8862.
- Determine the overall survival in patients treated with this drug.
- Determine the time to progression in patients treated with this drug.
- Determine the duration of response (CR and PR) in patients treated with this drug.
- Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
- Determine the pharmacokinetic profile of this drug in selected patients.
OUTLINE: This is a multicenter, open-label study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate:
- •Diffuse large B-cell lymphoma
- •Transformed NHL
- •Follicular large cell lymphoma
- •Peripheral T cell lymphoma
- •Anaplastic large cell lymphoma
- •Mantle cell lymphoma
- •Unclassified aggressive histology
- •Immunoblastic lymphoma
- •Failed at least 1 prior therapy (primary resistant) OR
- •Previously achieved a remission and then progressed or relapsed within 6 months of therapy
- •At least 1 bidimensionally measurable lesion
- •Lesions within a previously irradiated field are not considered measurable
- •No relapse within 6 months after prior autologous bone marrow transplantation
- •No prior allogeneic bone marrow or stem cell transplantation or post-transplant lymphoproliferative disorder
- •No parenchymal or meningeal CNS involvement unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 75,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement)
- •PT, INR, and PTT less than 1.5 times ULN
- •No chronic hepatitis B or C
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No clinically evident congestive heart failure
- •No New York Heart Association class III or IV heart disease
- •No serious cardiac arrhythmias
- •No active coronary artery disease or ischemia
- •No prior hypersensitivity to taxane compounds
- •No known or suspected allergy to the investigational study agent or any agent given in association with this study
- •No other prior or concurrent malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the bladder or cervix (adequately cone biopsied)
- •No substance abuse or medical, psychological, or social conditions that would preclude study participation
- •No active clinically serious infections
- •No other condition that is unstable or would preclude study participation
- •No grade 2 or greater pre-existing peripheral neuropathy
- •No history of seizure disorder
- •Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY:
- 另有 37 项未显示
排除标准
- 未提供
研究者
研究点 (30)
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