Pediatric Solid Tumor Clinical Trial
Official title:
Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |