NCT00225992终止2 期
A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Oncology Specialties, Alabama3 个研究点 分布在 1 个国家开始时间: 2004年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 试验地点
- 3
研究概览
简要总结
In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule.
Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Myelodysplastic Syndrome by FAB. Can be made with cytogenetic analysis of Bone Marrow or Hematologist evaluation
- •Patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment
- •ECOG performance status of 0-2
- •An EKG must be performed within 7 days prior to treatment to confirm QT interval <460msec.
- •Serum creatinine less than or equal to 2.5 times the upper limit of normal.
- •Serum bilirubin less than or equal to 2.5 times the upper limit of normal.
- •Serum potassium greater than or equal to 4.0 mEq/dL and serum magnesium greater than or equal to 1.8 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.
- •Patients must be 18 years of age to participate in this study
排除标准
- •Pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception.
- •Corrected QT interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range.
- •Significant CHF, coronary is ischemia or serious Arrhythmias including conduction delays.
- •Peripheral neuropathy greater than or equal to
- •Evidence of active infection
- •Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
- •Inability or unwillingness to comply with the treatment protocol, follow up, or research tests.
研究者
研究点 (3)
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