NCT00939965Unknown不适用
Pilot Study to Investigate the Feasibility of 13-cis-retinoic Acid Pharmacokinetic Monitoring in High-risk Neuroblastoma Patients
Children's Cancer and Leukaemia Group6 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2009年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Pharmacokinetics of isotretinoin
研究概览
简要总结
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors plan better treatment for patients receiving isotretinoin.
PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.
详细描述
OBJECTIVES:
Primary
- To investigate the feasibility of implementing individualized dosing of isotretinoin in patients with high-risk neuroblastoma after course 1 of treatment, based on isotretinoin pharmacokinetics and toxicity.
- To minimize the large inter-patient variation in plasma concentrations of isotretinoin.
- To ensure that patients are not exposed to potentially sub-optimal plasma concentrations of isotretinoin during long-term treatment, particularly for patients who are not able to swallow isotretinoin capsules.
Secondary
- To obtain preliminary data on the potential impact of isotretinoin therapeutic monitoring on clinical response and toxicity in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed high-risk neuroblastoma
- •Concurrent isotretinoin as part of clinical treatment
- •PATIENT CHARACTERISTICS:
- •Not pregnant
- •Fertile patients must use effective contraception
- •Has a single- or double-lumen central venous catheter in place
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetics of isotretinoin
Toxicity according to NCI CTCAE v.3
次要结局
- Clinical response
研究者
研究点 (6)
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