A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Satey and Tolerability
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. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.
详细描述
OBJECTIVES:
- Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia.
- Determine potential dose-limiting toxic effects in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least 12 patients for phase II) will be accrued for this study .
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting one of the following criteria:
- •Chronic phase
- •Less than 15% blasts in peripheral blood or marrow
- •Less than 30% blasts and promyelocytes in peripheral blood or marrow
- •Less than 20% basophils in blood or marrow
- •Platelet count at least 100,000/mm^3 (unless therapy related)
- •No progressive (increase of at least 10 cm in any 4 of the past 24 weeks) or existing (greater than 10 cm) splenomegaly
- •Complete hematologic response (CHR)
- •No immature myeloid cells in peripheral blood
- •No increased basophils in peripheral blood
- •WBC less than upper limit of normal (ULN)
- •Platelet count less than ULN
- •No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response after at least 6 months of imatinib mesylate
- •Loss of prior major cytogenetic response or failure to achieve major cytogenetic response
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin less than 1.5 times ULN
- •AST or ALT less than 2.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Cardiovascular
- •No New York Heart Association grade III or IV congestive heart failure
- •No untreated symptomatic cardiac ischemia
- •No underlying cardiac arrhythmia, including but not limited to any of the following:
- •Conduction abnormality/atrioventricular heart block
- •Nodal/junctional arrhythmia/dysrhythmia
- •Sinus bradycardia or tachycardia
- •Supraventricular tachycardia
- •Ventricular arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 methods of effective barrier contraception during and for 3 months after study
- •Electrolyte levels (especially potassium and magnesium) normal (CHR patients)
- •No history of noncompliance that would preclude study participation
- •No other concurrent serious, uncontrolled medical condition
- •No grade 2 or greater neuropathy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Satey and Tolerability
Pharmacokinetics
Dose-limiting toxicity
次要结局
未报告次要终点