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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
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin-treatment arm | Experimental | Arm description : Carboplatin intravenous administration once daily for 3 to 4 days
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Blood sampling will be done at the time before administration (0hr pre-dose), 1hr, 2hr, 5hr for pharmacokinetic study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of carboplatin at the first and last administration day | From the start of first dose carboplatin administration to 5 hours from the last administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events after HSCT using carboplatin as the conditioning regimen | Especially, kidney function will be focused. | From the start of carboplatin administration to 100 days from hematopoietic stem cell transplantation |
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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.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Young Shin, MD, PhD | Contact | 82-2-2072-2917 | hyshin@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hee Young Shin, MD, PhD | Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |