The Pharmacokinetics and Pharmacodynamics of Vincristine in the Adolescent and Young Adult Population Compared to Younger Children
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Vincristine (concentration of vincristine)
研究概览
简要总结
The trial is to determine if a difference exists in the way that adolescents and young adults metabolize the chemotherapy agent vincristine compared to younger children.
详细描述
The purpose of the study is to refine the PK model for planning a future definitive study. This is a pilot study to obtain preliminary data on the pharmacokinetics of VCR and the way it differs in the AYA population compared to the younger children as defined by Tanner staging. Additionally, we want to determine if Calpain levels correlate with vincristine and its PK and to determine if it can be used as biomarker for VRNT.
Specific Aim 1: Develop a non-parametric population model of vincristine and M1 PK in children and adolescents.
Hypothesis: The PK of vincristine and its metabolite M1 will differ between young children and AYA as defined by Tanner stage
Specific Aim 2: Measure repeated serum calpain with initiation of vincristine and again after four weeks of therapy.
Hypothesis: Compared to baseline, serum calpain will increase after administration of vincristine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 1-24 years of age with Acute Lymphoblastic Leukemia
- •Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in Induction phase of therapy
- •Patient diagnosed with Acute Lymphoblastic Leukemia (ALL) in first remission in Maintenance phase of therapy Treatment plan for induction therapy includes vincristine given at weekly intervals.
- •Treatment plan for Maintenance therapy includes vincristine given at monthly intervals.
排除标准
- •Patients without a central line in induction phase of therapy
结局指标
主要结局
Vincristine (concentration of vincristine)
时间窗: 4 weeks
We will evaluate the concentration of vincristine in relations to the production of primary metabolite M1 over time. Vincristine is primary metabolized using CYP3A family of enzymes is responsible.
次要结局
- Calpain level(4 weeks)
- Cytochrome P450 3A5 genotype(One time)
- Development of Vincristine Induced Neuropathy(4 weeks)
研究者
Leidy Isenalumhe
Hematology-Oncology Fellow
Children's Hospital Los Angeles