NCT00081133已完成1 期
A Phase I/II Study to Determine Safety and Efficacy of Arsenic Trioxide (Trisneox™) in Combination With Imatinib (STI571, Gleevec™) in Patients With Chronic Myelogenous Leukemia in Accelerated or Blastic Phase Disease or Ph+ Acute Lymphoblastic Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in 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 their growth. Combining arsenic trioxide with imatinib mesylate may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolererated dose of arsenic trioxide when administered with imatinib mesylate in patients with accelerated or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
- Determine the rate of complete morphologic remission in the bone marrow of patients treated with this regimen.
OUTLINE: This is a phase I dose-escalation study of arsenic trioxide followed by a phase II study.
- Phase I:
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Diagnosis of one of the following:
- •Chronic myelogenous leukemia (CML) in one of the following phases:
- •Blastic phase*
- •Accelerated phase*
- •No appropriate donors for stem cell transplantation NOTE: *Must have received high-dose (600-800 mg/day) imatinib mesylate of no more than 3 months duration
- •Acute lymphoblastic leukemia
- •Philadelphia chromosome positive by cytogenetic confirmation
- •Patients with only bcr-abl-positive disease by polymerase chain reaction are not eligible
- •> 10% blasts in the bone marrow
- •No isolated extramedullary disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST ≤ 2 times ULN
- •INR and PTT ≤ 1.5 times ULN (except for patients on anticoagulation therapy)
- •Creatinine ≤ 2 times ULN
- •Cardiovascular
- •Baseline QTc intervals < 480 ms
- •No chronic arrhythmias
- •No active coronary artery disease
- •No chronic electrolyte abnormalities
- •No prior non-compliance to medical regimens
- •No patients who are considered potentially unreliable
- •No active serious infection
- •No other active malignancies except superficial epithelial cancers
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior peripheral blood stem cell or bone marrow transplantation
- •Chemotherapy
- •Prior hydroxyurea allowed
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •More than 4 weeks since prior major surgery and recovered
- •Prior anagrelide allowed
- •No concurrent warfarin for therapeutic anticoagulation
- •Concurrent low molecular weight heparin is allowed
排除标准
- 未提供
研究者
研究点 (2)
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