Clinical trial NCT02339753: Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
Official title: Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pediatric Solid Tumor
Lead sponsor: The Korean Society of Pediatric Hematology Oncology
Sponsor class: NETWORK
First posted: 2015-01-15
Enrollment: 24
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
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:
measure: Number of participants with adverse events after HSCT using carboplatin as the conditioning regimen
timeFrame: From the start of carboplatin administration to 100 days from hematopoietic stem cell transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea
name: Hee Young Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: