Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 8
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.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have myelodysplastic syndromes.
详细描述
OBJECTIVES:
- Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide.
- Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug.
- Determine the durability of responses in patients treated with this drug.
- Determine the duration of overall and progression-free survival of patients treated with this drug.
- Assess the quality of life of patients treated with this drug.
- Assess the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk).
Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion.
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 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 syndromes (MDS)
- •Refractory anemia (RA)
- •RA with ringed sideroblasts
- •RA with excess blasts (RAEB)
- •RAEB in transformation
- •Chronic myelomonocytic leukemia
- •Low-risk MDS patients:
- •If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant epoetin alfa (EPO) trial
- •No prior acute myeloid leukemia
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- •SGPT and SGOT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •Absolute QT interval less than 460 msec in the presence of magnesium greater than 1.8 mg/dL and potassium greater than 4.0 mEq/L
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS patients)
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 30 days since prior radiotherapy
- •Not specified
- •At least 30 days since prior cytotoxic agents
- •At least 30 days since prior investigational agents
- •No prior arsenic trioxide
排除标准
- 未提供