A Phase II Study of Epothilone B Analog BMS-247550 (NSC 710428) in Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Safety and Toxicity of Ixabepilone
研究概览
简要总结
This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.
详细描述
OBJECTIVES:
I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).
II. Determine the safety and toxicity of this drug in these patients. III. Determine the duration of response, overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multi-center study.
Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
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 aggressive non-Hodgkin's lymphoma of 1 of the following cellular types:
- •Grade III follicular center
- •Diffuse large B-cell
- •Mantle cell
- •Primary mediastinal B-cell
- •Burkitt's
- •High-grade B-cell (Burkitt-like)
- •Anaplastic large cell of 1 of the following subtypes:
- •CD30-positive
- •Null cell
- •Hodgkin's-like
- •Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1of the following cohorts:
- •Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy
- •Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy
- •No progressive disease after the most recent prior therapy
- •Measurable disease
- •At least 1 bidimensionally measurable lesion at least 10 mm by conventional techniques or clinical exam
- •Ineligible for or unwilling to undergo hematopoietic stem cell transplantation
- •Patients requiring debulking prior to transplant allowed
- •No known CNS involvement by lymphoma
- •Prior CNS disease that has been successfully treated in patients with relapsed disease exclusively outside of the CNS may be allowed by the principal investigator
- •Performance status - ECOG 0-2
- •More than 3 months
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,200/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reaction or hypersensitivity to compounds containing Cremophor EL or agents of similar chemical or biological composition to BMS-247550
- •No peripheral neuropathy grade 2 or greater
- •No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (previously treated malignancy allowed if considered to be at less than 30% risk of relapse)
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •No colony-stimulating factors (CSFs) within 24 hours of study chemotherapy
- •No CSFs during first course of study therapy
- •No concurrent filgrastim-SD/01
- •No concurrent immunotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No other concurrent chemotherapy
- •No concurrent hormonal therapy
- 另有 10 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy)
Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
干预措施: ixabepilone (Drug)
结局指标
主要结局
Safety and Toxicity of Ixabepilone
时间窗: up to 3 years
Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone.
Objective Overall Response Rate
时间窗: up to 3 years
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
次要结局
- Time to Progression(up to 3 years)
- Duration of Response(up to 3 years)
- Overall Survival(up to 3 years)