Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) of carboplatin at the first and last administration day
研究概览
简要总结
Carboplatin is widely used for conditioning regimens of autologous hematopoietic stem cell transplantation for pediatric solid tumor, but the pharmacokinetics has not been evaluated in pediatric stem cell transplantation before. As carboplatin have renal toxicity, the pharmacokinetic study of carboplatin would help the safe and effective administration of carboplatin for transplantation patients. Especially, the dose of carboplatin is higher at conditioning chemotherapy, resulting in higher toxicity.
Carboplatin is a drug mostly excreted by kidney, and the dose of carboplatin is recommended according to the body surface area and kidney function, represented by glomerular filtration rate. After analyzing the pharmacokinetics of carboplatin, analyses will also be done for the methods to determine the appropriate carboplatin dose.
详细描述
Purpose
- Primary objective: To evaluate the pharmacokinetics of carboplatin in pediatric HSCT patients.
- Secondary objective: To evaluate the toxicity of HSCTs using carboplatin as the conditioning regimen. To compare the pharmacokinetics of carboplatin in adults and children.
Eligibility Inclusion criteria
-
Patients who undergo HSCT with conditioning regimen including carboplatin. 2. Age under 19 years. 3. Performance status: ECOG 0-2. 4. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
-
Heart: a shortening fraction > 30% and ejection fraction > 45%.
-
Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.
-
Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
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
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo HSCT with conditioning regimen including carboplatin.
- •Age under 19 years.
- •Performance status: ECOG 0-
- •Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
- •Heart: a shortening fraction > 30% and ejection fraction > 45%.
- •Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.
- •Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m
- •Patients must lack any active viral infections or active fungal infection.
- •Patients (or one of parents if patients age < 19) should sign informed consent.
排除标准
- •Pregnant or nursing women.
- •Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- •Psychiatric disorder that would preclude compliance.
- •If the clinician decides that there is a condition improper for the clinical study.
研究组 & 干预措施
Carboplatin-treatment arm
Arm description : Carboplatin intravenous administration once daily for 3 to 4 days
- Topotecan + Thiotepa + Carboplatin : carboplatin 500mg/m2/day, for 3 days
- MEC for 2nd PBSCT : carboplatin 350 mg/m2/day, for 4 days
- MEC for other solid tumor : carboplatin 400 mg/m2/day, for 4 days
- MEC + MIBG Tx for 2nd PBSCT (neuroblastoma) : carboplatin 300 mg/m2/day, for 4 days
干预措施: Carboplatin (Drug)
结局指标
主要结局
Area Under Curve (AUC) of carboplatin at the first and last administration day
时间窗: From the start of first dose carboplatin administration to 5 hours from the last administration
次要结局
- Number of participants with adverse events after HSCT using carboplatin as the conditioning regimen(From the start of carboplatin administration to 100 days from hematopoietic stem cell transplantation)