Pediatric Solid TumorPhase 2NCT02339753
Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Carboplatin in people with Pediatric Solid Tumor, run by The Korean Society of Pediatric Hematology Oncology at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Pediatric Solid Tumor
- What is being tested?
- Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
HeeYeong shin
About this study
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.
Read the detailed description
Purpose
- Primary objective: To evaluate the pharmacokinetics of carboplatin in pediatric HSCT patients.
- 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
- 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.
Exclusion criteria
- 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.
- Conditions
- Pediatric Solid Tumor
- Being tested
- Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Neoplatin
Blood sampling will be done at the time before administration (0hr pre-dose), 1hr, 2hr, 5hr for pharmacokinetic study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) of carboplatin at the first and last administration day
Measured: 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
Especially, kidney function will be focused.
Measured: From the start of carboplatin administration to 100 days from hematopoietic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Korean Society of Pediatric Hematology Oncology
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hee Young Shin, MD, PhD, Principal investigator, Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339753
- Sponsor's protocol ID
- SNUCH_carboplatinPK
- Status last verified
- Jan 2015
- First submitted
- 2 Jan 2015
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02339753
- Acronym / sponsor ID
- SNUCH_carboplatinPK
- Conditions
- Pediatric Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Korean Society of Pediatric Hematology OncologyResearch network
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary objective: To evaluate the pharmacokinetics of carboplatin in pediatric HSCT patients.
- 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
- 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.
Exclusion criteria
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin-treatment arm | Experimental | Drug: CarboplatinArm 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 |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: NeoplatinBlood sampling will be done at the time before administration (0hr pre-dose), 1hr, 2hr, 5hr for pharmacokinetic study. | Drug | Carboplatin-treatment arm |
Primary outcome
Area Under Curve (AUC) of carboplatin at the first and last administration day
Time frame: From the start of first dose carboplatin administration to 5 hours from the last administration
1 secondary outcome
Number of participants with adverse events after HSCT using carboplatin as the conditioning regimen
Time frame: From the start of carboplatin administration to 100 days from hematopoietic stem cell transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Young Shin, MD, PhD principal investigator
Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin in people with Pediatric Solid Tumor, run by The Korean Society of Pediatric Hematology Oncology at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Young Shin, MD, PhD (82-2-2072-2917, hyshin@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) of carboplatin at the first and last administration day (time frame: From the start of first dose carboplatin administration to 5 hours from the last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.