Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Pharmacokinetics (PK)
研究概览
简要总结
RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer.
PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.
详细描述
OBJECTIVES:
- To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol NCI-00-C-0070J.
OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms (AsIII and AsV), and methylated metabolites of As are assessed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Correlation of PK and PD with clinical parameters, such as age, gender, and dose
次要结局
未报告次要终点