Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02339753
Study type Interventional
Source The Korean Society of Pediatric Hematology Oncology
Contact Hee Young Shin, MD, PhD
Phone 82-2-2072-2917
Email hyshin@snu.ac.kr
Status Recruiting
Phase Phase 2
Start date January 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05151718 - Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents
Recruiting NCT02787876 - Pegteograstim in Children With Solid Tumors Phase 2
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Recruiting NCT05620862 - Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors Phase 1
Active, not recruiting NCT02520713 - The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study
Recruiting NCT05468359 - Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients Phase 1/Phase 2
Completed NCT04944875 - Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging. N/A
Recruiting NCT03618381 - EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Phase 1
Recruiting NCT04897321 - B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR) Phase 1
Completed NCT05024331 - A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor
Active, not recruiting NCT04483778 - B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Phase 1
Active, not recruiting NCT04239040 - GVAX Plus Checkpoint Blockade in Neuroblastoma Phase 1
Recruiting NCT03739827 - Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Completed NCT03222258 - Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients
Completed NCT02564198 - A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors Phase 1
Recruiting NCT03273829 - Study of Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children With Relapsed or Refractory Solid Tumors and Leukemias Phase 1
Completed NCT03455140 - A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100) Phase 1/Phase 2
Completed NCT01853345 - iCAT for Recurrent/Refractory/HR Solid Tumors N/A
Active, not recruiting NCT03478462 - Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma Phase 1
Not yet recruiting NCT05322187 - Sequential PD-1/PD-L1 Inhibitor and LENvatinib in TLCT and Refractory Hepatoblastoma After Chemotherapy Phase 2/Phase 3