NCT00118196终止2 期
A Phase II Study of Arsenic Trioxide in Combination With 5-Azacitidine in Myelodysplastic Syndromes
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Response rate (overall and confirmed) as measured by International Working Group (IWG) standardized criteria for MDS at day 113 and then every 4 weeks until completion of study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving azacitidine together with arsenic trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with azacitidine and arsenic trioxide.
Secondary
- Determine time to treatment failure in patients treated with this regimen.
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine progression-free survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia
- •International Prognostic Scoring System (IPSS) score ≥ intermediate-1
- •Low IPSS score allowed provided patient meets ≥ 1 of the following criteria:
- •Platelet count ≤ 50,000/mm^3
- •Required platelet or packed red cell transfusions within the past 4 weeks
- •Neutropenic (i.e., absolute neutrophil count < 1,000/mm^3) AND has infections requiring antibiotic treatment
- •No prior leukemia or refractory anemia with excess blasts in transformation
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Baseline QTc < 500 msec
- •QTc interval < 460 msec with potassium > 4.0 mEq/L and magnesium > 1.8 mg/L
- •Immunologic
- •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
- •No ongoing or active infection
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study participation
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No other malignancy within the past 12 months
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior administration of any of the following:
- •Interferon
- •Filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or other hematopoietic cytokines
- •Thalidomide or thalidomide analogs
- •No concurrent epoetin alfa
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy
- •No prior arsenic trioxide or azacitidine
- •No other concurrent chemotherapy
- •Endocrine therapy
- •More than 4 weeks since prior steroids
- •No concurrent androgenic steroids
- •Concurrent steroids for adrenal failure or as prophylaxis for nausea allowed
- •Radiotherapy
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate (overall and confirmed) as measured by International Working Group (IWG) standardized criteria for MDS at day 113 and then every 4 weeks until completion of study treatment
次要结局
- Time to treatment failure as assessed by the Kaplan-Meier method at completion of study treatment
- Toxicity as assessed by the Kaplan-Meier method and NCI-CTCAE version 3.0 during treatment until 30 days after completion of study treatment
- Progression-free survival as assessed by the Kaplan-Meier method at completion of study treatment
研究者
研究点 (1)
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