NCT00047021已完成2 期
A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Event free survival at day 14 (myeloid engraftment)
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. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.
详细描述
OBJECTIVES:
- Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma.
- Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen.
OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed.
Patients are followed for 3 months.
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
- — 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •One of the following must be present:
- •Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia
- •More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy
- •Failed at least 1 attempt at induction chemotherapy
- •Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma
- •Refractory or relapsed after at least 1 regimen of standard chemotherapy
- •Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis
- •Received at least 1 myelotoxic chemotherapy regimen
- •Active CNS involvement allowed
- •PATIENT CHARACTERISTICS:
- •55 and under
- •Performance status
- •Life expectancy
- •At least 5 weeks
- •Hematopoietic
- •Lymphoma patients:
- •WBC at least 2,000/mm^3*
- •Platelet count at least 20,000/mm^3* NOTE: *Unless due to bone marrow involvement or disease process
- •Bilirubin no greater than 3 times normal*
- •AST/ALT no greater than 3 times normal*
- •Alkaline phosphatase no greater than 3 times normal*
- •No severe liver failure NOTE: *Unless related to leukemia
- •Creatinine clearance greater than 50 mL/min
- •No severe renal failure
- •Cardiovascular
- •LVEF at least 45% by MUGA
- •DLCO at least 60% of predicted
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychiatric illness that would preclude informed consent
- •No medical illness or other condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •At least 24 hours since prior hydroxyurea
- •At least 1 week since other prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •Recovered from prior therapy
排除标准
- 未提供
结局指标
主要结局
Event free survival at day 14 (myeloid engraftment)
时间窗: day 14
次要结局
- Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment(followed for 3 months)
研究者
研究点 (1)
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