A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Characterization of Plasma Pharmacokinetics to examine the optimal dosing, metabolites and inter-patient variability of actinomycin-D in children with cancer during any sample of chemotherapy.
研究概览
简要总结
To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.
详细描述
There is a fundamental lack of knowledge regarding optimal dosing of anti-cancer agents for young children with cancer, with resultant increased risk of morbidity, mortality and inferior outcome. Of the anti-cancer agents used frequently in infants and young children, the drug with the least amount of knowledge is actinomycin-D. Actinomycin-D, has been used for the treatment of several childhood cancers since the 1960s. Despite its longstanding and widespread use in pediatric oncology, there is virtually no pharmacokinetic information from which safe and appropriate age-based pediatric dosing can be derived. Actinomycin-D is an integral component of rhabdomyosarcoma and Wilms tumor therapy, and pediatric oncologists will continue to administer the durg despite the gap in knowledge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •6 months - 18 years
- •Due to receive actinomycin-D as a component of cancer treatment
- •Central venous catheter (e.g. Port-a Cath, Broviac)
- •Informed consent of parent or legal guardian and patient assent when appropriate
排除标准
- •Serious illness other than the primary diagnosis of cancer
- •Weight < 5 kilograms
- •Previous participation in CHP-810
结局指标
主要结局
Characterization of Plasma Pharmacokinetics to examine the optimal dosing, metabolites and inter-patient variability of actinomycin-D in children with cancer during any sample of chemotherapy.
次要结局
未报告次要终点