Pediatric Solid Tumor
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGCarboplatin
Blood sampling will be done at the time before administration (0hr pre-dose), 1hr, 2hr, 5hr for pharmacokinetic study.
Sponsors
The Korean Society of Pediatric Hematology Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Especially, kidney function will be focused. |
Countries
South Korea
Contacts
Primary ContactHee Young Shin, MD, PhD
Outcome results
None listed