NCT00003245已完成2 期
Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with recurrent or refractory non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkin's lymphoma.
OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being refractory (no complete response (CR) or partial response (PR) to initial therapy) vs recurrent (CR or PR to initial therapy); i.e, the following subcategories are used:
- Stratum I:Refractory aggressive non-Hodgkin's lymphoma (NHL)
- Stratum II:Recurrent aggressive NHL
- Stratum III: Refractory indolent NHL
- Stratum IV: Recurrent indolent NHL
- Stratum V: Mantle cell NHL All patients receive irinotecan intravenously every 21 days. Patients achieving CR or PR receive 6 courses. Patients may receive bone marrow transplantation after at least 2 courses.
Patients are followed every 3 months for survival.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma
- •First relapse requires histologic confirmation of relapse
- •No CNS metastases
- •No lymphomatous meningitis
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Unless due to lymphoma:
- •Platelet count at least 100,000/mm^3
- •Absolute granulocyte count at least 1,500/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement)
- •Creatinine no greater than 2.0 mg/dL
- •Baseline calcium less than 12 mg/dL
- •Cardiovascular:
- •No myocardial infarction within 6 months
- •No congestive heart failure requiring therapy
- •No history of seizures
- •No uncontrolled diabetes mellitus (i.e., random blood sugar of at least 250 mg)
- •No other concurrent severe disease
- •No uncontrolled infection
- •HIV negative
- •No psychoses
- •No prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix unless surgically treated and disease free for at least 5 years
- •Not pregnant or lactating
- •Effective contraception required of fertile patients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior bone marrow transplantation
- •Chemotherapy:
- •No more than 2 prior chemotherapy regimens for treatment of lymphoma
- •No prior irinotecan, topotecan or aminocamptothecin
- •At least 3 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy
- •Radiotherapy that is not a part of a combined-modality therapy is counted as a regimen (see Chemotherapy)
- •Not specified
- •No phenytoin, phenobarbital, or other antiepileptic prophylaxis
排除标准
- 未提供
研究者
研究点 (1)
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