Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation

NCT ID: NCT02339753

Last Updated: 2015-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Pediatric Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboplatin-treatment arm

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

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Blood sampling will be done at the time before administration (0hr pre-dose), 1hr, 2hr, 5hr for pharmacokinetic study.

Interventions

Carboplatin

Blood sampling will be done at the time before administration (0hr pre-dose), 1hr, 2hr, 5hr for pharmacokinetic study.

Intervention Type: DRUG

Other Intervention Names

Neoplatin

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.

• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Korean Society of Pediatric Hematology Oncology

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hee Young Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hee Young Shin, MD, PhD

Role: CONTACT

hyshin@snu.ac.kr

82-2-2072-2917

Other Identifiers

SNUCH_carboplatinPK

Identifier Type: -

Identifier Source: org_study_id