NCT00234000终止1 期
A Phase I Multicenter Study of Arsenic Trioxide and Azacitidine in Patients With Myelodysplastic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety and tolerability as assessed by NCI CTCAE v3.0 (Phase I)
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 I/II trial is studying the side effects and best dose of azacitidine when given together with arsenic trioxide and to see how well they work in treating patients with myelodysplastic syndromes.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of azacitidine when given in combination with arsenic trioxide in patients with myelodysplastic syndromes (MDS). (Phase I)
- Determine the safety and tolerability of this regimen in these patients. (Phase I)
- Determine the major hematologic response (erythroid response) rate in patients with transfusion-dependent lower-risk MDS treated with this regimen. (Phase II)
- Determine complete and partial remission rates in patients with higher-risk MDS treated with this regimen. (Phase II)
- Determine the toxicity profile of this regimen in these patients. (Phase I)
Secondary
- Determine time to disease progression in patients treated with this regimen. (Phase I and II)
- Determine the overall and progression-free survival of patients treated with this regimen. (Phase I and II)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of MDS by standard criteria. Patients within each of the FAB diagnostic groups of RA, RARS, RAEB, RAEBt, and CMML are eligible. For patients with lower-risk MDS only: documented red blood cell dependence, defined as the inability to maintain a hematocrit of > 25% without transfusion support.
- •Adequate marrow iron stores
- •In patients with serum erythropoietin less than 200 IU/mL at screening, failure to have responded to a 2 to 3 month trial of recombinant erythropoietin
- •Serum creatinine or serum bilirubin < 1.5 times the upper limit of normal; higher levels are acceptable if ALT levels < 2 x upper limits of normal
- •Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine/treatment.
- •Women of childbearing potential should be advised to avoid becoming pregnant and should be advised to not father a child while receiving treatment with azacitidine
- •Age > 18 years
排除标准
- •Treatment with growth factors within the 30 days before first treatment with ATO/Azacitidine, except that patients with serum erythropoietin < 200 IU/mL who failed to respond to a trial with EPO are not excluded regardless of the time since last EPO
- •Treatment with cytotoxic or experimental agents within 30 days before first treatment with ATO/Azacitidine
- •Absolute QT interval > 460 msec in the presence of adequate serum potassium and magnesium values
- •Active serious infections that are not controlled by antibiotics
- •Pregnant or lactating women
- •Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
- •NYHA Class III or IV heart failure
- •Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
研究组 & 干预措施
Arm 1
Experimental
see description in intervention
干预措施: arsenic trioxide (Drug)
Arm 1
Experimental
see description in intervention
干预措施: azacitidine (Drug)
结局指标
主要结局
Safety and tolerability as assessed by NCI CTCAE v3.0 (Phase I)
时间窗: Every 28 days upto 8 months
次要结局
- Time to disease progression(Participants are folowed for an average of 1 year after completion of study treatment)
- Overall survival(Participants are followed every 3-12 months for survival)
研究者
研究点 (1)
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