A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
详细描述
OBJECTIVES:
I. Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.
II. Determine the treatment-related toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive).
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
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 or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype
- •Follicular small cleaved cell
- •Follicular mixed cell
- •Small lymphocytic
- •Mucosa-associated lymphoid tissue (MALT)
- •Monocytoid B-cell
- •Waldenstrom's macroglobulinemia
- •Aggressive
- •Follicular large cell
- •Diffuse large cell
- •Immunoblastic
- •Mantle cell
- •Ki-1+ NHL
- •Peripheral T-cell
- •Angiocentric and angioimmunoblastic
- •Transformed lymphoma
- •Bidimensionally measurable disease
- •No more than 3 prior treatment regimens as follows:
- •Primary radiotherapy is 1 regimen
- •Combined therapy with radiotherapy and chemotherapy is 1 regimen
- •Alternating therapy is 1 regimen
- •No known brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 50-100%
- •WBC count at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •SGOT/SGPT no greater than 2.5 times upper limit of normal
- •Creatinine normal
- •Creatinine clearance at least 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No neuropathy greater than grade 1
- •No history of allergy to platinum compounds or antiemetics
- •No uncontrolled illness
- •No active infection
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No concurrent colony-stimulating factors during first course of therapy
- •At least 4 weeks since prior chemotherapy
- •At least 4 weeks since prior radiotherapy
- •No other concurrent investigational drugs
- •No concurrent antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (oxaliplatin)
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Response rate
时间窗: Up to 6 years
Using a Simon's two-stage model.
次要结局
- Duration of response(Up to 6 years)