Clinical trial · Interventional
Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Solid Tumor | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin-treatment arm
- description
- 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
- interventionNames
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Area Under Curve (AUC) of carboplatin at the first and last administration day
- timeFrame
- From the start of first dose carboplatin administration to 5 hours from the last administration
Secondary outcomes (1)
- measure
- Number of participants with adverse events after HSCT using carboplatin as the conditioning regimen
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
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