CHildren Treated With Vincristine: A Trial Regarding Pharmacokinetics, DNA And Toxicity of Targeted Therapy In Pediatric Oncology Patients.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adapting vincristine dosage
研究概览
简要总结
The goal of this clinical trial is to individualize the dosage of vincristine, a chemotherapy drug, in children with cancer. The main question it aims to answer is: can vincristine dosage be optimized while carefully monitoring toxicity.
The following will happen:
- Participants will receive vincristine according to the institutional treatment protocol.
- After receiving vincristine, blood samples will be taken at three time points.
- The amount of vincristine in the blood samples will be determined.
- If the amount of vincristine in the blood samples is lower than the reference and the participants do not experience toxicity due to vincristine, the dose of vincristine may be increased.
- Toxicity will be carefully monitored.
详细描述
Vincristine is among the most widely used and potentially effective chemotherapeutic agents in pediatric oncology patients. However, in black African children it may be sub optimally dosed due to genetic differences in the metabolism of vincristine. This study aims to optimize the dosing regimen of vincristine while carefully monitoring toxicity.
This will be a prospective cohort study consisting of two parts: a feasibility study and the rest of the study. In the feasibility study, 15 children aged 5-14 years who are scheduled to receive at least 2 vincristine administrations can be included. After the administration of vincristine, venous blood samples and finger prick blood samples will be taken to determine the vincristine concentrations. The samples will be shipped to and analyzed in the Netherlands to determine the vincristine concentration in each sample. Based on this, a dose advise will be given for subsequent vincristine administrations. This cycle will be repeated maximum 2 times but maximum 1 dose advice is given. Toxicity will be monitored by determination of the bilirubin, by questionnaires and by physical examination to check for signs of peripheral neuropathy. In the rest of the study, in which 85 children will be included, only finger prick samples will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Black patients aged 5-14 years with a malignancy for which they are scheduled to receive a minimum of two VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma.
- •Written informed consent
排除标准
- •Severe malnutrition
- •Total bilirubin >3 times upper limit of normal
- •Pre-existent severe mental retardation e.g. Down syndrome
- •Pre-existent peripheral neuropathy (CTCAE constipation, peripheral sensory neuropathy, peripheral motor neuropathy, or neuralgia ≥ 2 or ped-mTNS ≥ 5)
- •Rest of the study:
- •Inclusion Criteria:
- •Black patients aged 2-14 years with a malignancy for which they are scheduled to receive a minimum of four VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma.
- •Written informed consent
- •Exclusion Criteria:
- •Severe malnutrition
- •Total bilirubin >3 times upper limit of normal
- •Pre-existent severe mental retardation e.g. Down syndrome
- •Pre-existent peripheral neuropathy (CTCAE constipation, peripheral sensory neuropathy, peripheral motor neuropathy, or neuralgia ≥ 2 or ped-mTNS ≥ 5)
研究组 & 干预措施
Vincristine
A dose advice for vincristine will be given based on vincristine concentrations in blood samples and toxicity monitoring.
干预措施: Vincristine (Drug)
结局指标
主要结局
Adapting vincristine dosage
时间窗: Through study completion, an average of four months per patient (depending on treatment protocol).
The number of patients in whom it is possible to adapt vincristine dosage based on vincristine concentrations in the blood at three time points and the presence of side-effects.
次要结局
- Vincristine pharmacokinetics(Through study completion, an average of four months per patient (depending on treatment protocol).)
- Vincristine-induced peripheral neuropathy(Through study completion, an average of four months per patient (depending on treatment protocol).)
- Genetics(Through study completion, an average of four months per patient (depending on treatment protocol).)