NCT02339753

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 2, 2015

Last Update Submit

January 15, 2015

Conditions

Pediatric Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Area Under Curve (AUC) of carboplatin at the first and last administration day

    From the start of first dose carboplatin administration to 5 hours from the last administration

Secondary Outcomes (1)

  • Number of participants with adverse events after HSCT using carboplatin as the conditioning regimen

    From the start of carboplatin administration to 100 days from hematopoietic stem cell transplantation

Study Arms (1)

Carboplatin-treatment arm

EXPERIMENTAL

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

Drug: Carboplatin

Interventions

CarboplatinDRUG

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

Also known as: Neoplatin
Carboplatin-treatment arm

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. 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.
  • Heart: a shortening fraction \> 30% and ejection fraction \> 45%.
  • Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal.
  • Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
  • \. 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.

You may not qualify if:

  • Pregnant or nursing women.
  • Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
  • Psychiatric disorder that would preclude compliance.
  • If the clinician decides that there is a condition improper for the clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

CarboplatinCisplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Hee Young Shin, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Young Shin, MD, PhD

CONTACT

82-2-2072-2917hyshin@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 15, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

KR(1)