Pediatric Solid Tumor Clinical Trial
Official title:
Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
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.
Purpose
1. Primary objective: To evaluate the pharmacokinetics of carboplatin in pediatric HSCT
patients.
2. 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
1. 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.
1. Heart: a shortening fraction > 30% and ejection fraction > 45%.
2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.
3. Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
5. Patients must lack any active viral infections or active fungal infection. 6. Patients
(or one of parents if patients age < 19) should sign informed consent.
Exclusion criteria
1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be
jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
4. If the clinician decides that there is a condition improper for the clinical study.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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