Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation

The Korean Society of Pediatric Hematology Oncology

Status and phase: Unknown; Phase 2

Conditions: Pediatric Solid Tumor

Treatments: Drug: Carboplatin

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02339753

SNUCH_carboplatinPK

Details and patient eligibility

About

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.

Full 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.

2. Heart: a shortening fraction > 30% and ejection fraction > 45%.

3. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.

4. 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.

Enrollment: 24 estimated patients

Sex: All

Ages: Under 19 years old

Volunteers: No Healthy Volunteers

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.

2. Heart: a shortening fraction > 30% and ejection fraction > 45%.

3. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.

4. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Carboplatin-treatment arm

Experimental group

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

Treatment:

Drug: Carboplatin