Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
Summary
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2015-12
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 300 mg/m2 | Intravenous |
| Subject | Carboplatin | Small molecule | 350 mg/m2 | Intravenous |
| Subject | Carboplatin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Carboplatin | Small molecule | 500 mg/m2 | Intravenous |