Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
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 I trial to study the effectiveness of combining irinotecan with cytarabine in treating patients who have refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia.
详细描述
OBJECTIVES:
- Determine the activity of irinotecan and cytarabine in patients with refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia in myeloid blast transformation.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the maximum tolerated dose of irinotecan in this regimen in these patients.
- Correlate the clinical activity of this drug with cellular endpoints associated with DNA synthesis inhibition, DNA repair, induction of apoptosis, and drug resistance in these patients.
OUTLINE: This is a dose-escalation study of irinotecan.
Patients receive irinotecan IV over 90 minutes and cytarabine IV over 60 minutes on days 1-6. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. An additional 9 patients with refractory/relapsed acute myeloid leukemia and 9 patients with chronic myelogenous leukemia in myeloid blast transformation are treated at the MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed acute myeloid leukemia (M0-M7)
- •De novo or secondary disease
- •Previously treated and refractory to prior therapy (which has included high-dose cytarabine and an anthracycline)
- •Antecedent hematologic disorders allowed OR
- •Histologically confirmed Philadelphia chromosome-positive chronic myelogenous leukemia in myeloid blast transformation
- •Treated or untreated
- •Blast transformation defined by at least 20% blasts in marrow and/or blood
- •Myeloid lineage defined by immunophenotyping
- •PATIENT CHARACTERISTICS:
- •15 and over
- •Performance status
- •Life expectancy
- •At least 4 weeks
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •SGOT less than 2 times ULN
- •Creatinine less than 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •No other concurrent serious medical or psychiatric illness that would preclude study consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •Prior chemotherapy for an antecedent malignancy or other medical condition allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Prior radiotherapy for an antecedent malignancy or other medical condition allowed
- •Not specified
排除标准
- 未提供