Relapsed Pediatric Solid TumorPhase 2NCT02638428
Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy
A Phase 2 study testing CancerSCAN™, Ifosfamide and Carboplatin in people with Relapsed Pediatric Solid Tumor and Refractory Pediatric Solid Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and feasibility of combination chemotherapy with target agents according to the result of targeted deep sequencing in pediatric patients with relapsed/refractory solid tumor or AML. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Relapsed Pediatric Solid Tumor, Refractory Pediatric Solid Tumor, Relapsed Pediatric AML
- What is being tested?
- CancerSCAN™, Ifosfamide and Carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Dec 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Under 18 years of age at initial diagnosis
- Patients with refractory/relapsed solid tumor or AML (Solid tumor: Stable or progressive disease after 1st-line treatment or relapse; AML: Persistence after 2 cycles of induction chemotherapy or relapse)
- Patient with tumor sample which is adequate for targeted deep sequencing
Who cannot join
- Patients who had salvage chemotherapy previously
- Patients with organ dysfunction as follows (creatinine elevation ≥ 3 x upper limit of normal (ULN), ejection fraction <40%, significant arrhythmia or conduction disturbance)
- Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
- Patients whose tumor samples are not sufficient for targeted deep sequencing
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Woong Sung, 82-2-3410-3529, kwsped@skku.edu
Ki Woong Sung
About this study
The purpose of this study is to evaluate the efficacy and feasibility of combination chemotherapy with target agents according to the result of targeted deep sequencing in pediatric patients with relapsed/refractory solid tumor or AML.
Read the detailed description
Outcome of pediatric cancer has been improved substantially over the past few decades, but the prognosis of relapsed/refractory pediatric cancer still remains poor. Advances in genomic technologies have improved the ability to detect diverse somatic and germline genomic aberrations of cancer patients, and it has been incorporated in the clinical management of cancer.
Samsung Genomic Institute developed a targeted next-generation sequencing (NGS) platform, CancerSCAN™, which can detect clinically significant genomic aberrations of tumors. In this study, tumor samples of refractory/relapsed pediatric cancer patients will be tested with CancerSCAN™ and the patients will receive combination chemotherapy with matched single-targeted agent or multi-targeted receptor tyrosine kinase inhibitor according to the result of CancerSCAN™.
- Relapsed/refractory solid tumor
- Perform CancerSCAN™ at enrollment
- Conventional chemotherapy (ifosfamide, carboplatin, etoposide) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™
II. Relapsed/refractory AML
- Perform CancerSCAN™ at enrollment
- Conventional chemotherapy (fludarabine, cytarabine) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™
- Conditions
- Relapsed Pediatric Solid Tumor, Refractory Pediatric Solid Tumor, Relapsed Pediatric AML, Refractory Pediatric AML
- Being tested
- CancerSCAN™, Ifosfamide, Carboplatin, Etoposide, Fludarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CancerSCAN™Procedure or surgery
Targeted deep sequencing
IfosfamideDrug
CarboplatinDrug
EtoposideDrug
FludarabineDrug
CytarabineDrug
PazopanibDrug
SorafenibDrug
AxitinibDrug
CrizotinibDrug
DasatinibDrug
ErlotinibDrug
EverolimusDrug
ImatinibDrug
RuxolitinibDrug
VandetanibDrug
VemurafenibDrug
TrastuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Refractory/relapsed solid tumor or AML | Experimental | Conventional chemotherapy (Ifosfamide carboplatin etoposide for solid tumor and fludarabine cytarabine for AML) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™ Receives: Procedure: CancerSCAN™; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: Fludarabine; Drug: Cytarabine; Drug: Pazopanib; Drug: Sorafenib; Drug: Axitinib; Drug: Crizotinib; Drug: Dasatinib; Drug: Erlotinib; Drug: Everolimus; Drug: Imatinib; Drug: Ruxolitinib; Drug: Vandetanib; Drug: Vemurafenib; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of event free survival
Event is defined as relapse, disease progression or treatment-related mortality.
Measured: Up to 5 years
Secondary outcomes (1)
Rate of treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Pediatric Solid TumorStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Sponsor
- Investigators
- Ki Woong Sung, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638428
- Sponsor's protocol ID
- 2015-08-008
- Status last verified
- Mar 2020
- First submitted
- 29 Nov 2015
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy
- ClinicalTrials.gov ID
- NCT02638428
- Acronym / sponsor ID
- 2015-08-008
- Conditions
- Relapsed Pediatric Solid Tumor, Refractory Pediatric Solid Tumor, Relapsed Pediatric AML, Refractory Pediatric AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- Dec 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Dec 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.
The purpose of this study is to evaluate the efficacy and feasibility of combination chemotherapy with target agents according to the result of targeted deep sequencing in pediatric patients with relapsed/refractory solid tumor or AML.
Detailed description
Outcome of pediatric cancer has been improved substantially over the past few decades, but the prognosis of relapsed/refractory pediatric cancer still remains poor. Advances in genomic technologies have improved the ability to detect diverse somatic and germline genomic aberrations of cancer patients, and it has been incorporated in the clinical management of cancer.
Samsung Genomic Institute developed a targeted next-generation sequencing (NGS) platform, CancerSCAN™, which can detect clinically significant genomic aberrations of tumors. In this study, tumor samples of refractory/relapsed pediatric cancer patients will be tested with CancerSCAN™ and the patients will receive combination chemotherapy with matched single-targeted agent or multi-targeted receptor tyrosine kinase inhibitor according to the result of CancerSCAN™.
- Relapsed/refractory solid tumor
- Perform CancerSCAN™ at enrollment
- Conventional chemotherapy (ifosfamide, carboplatin, etoposide) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™
II. Relapsed/refractory AML
- Perform CancerSCAN™ at enrollment
- Conventional chemotherapy (fludarabine, cytarabine) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractory/relapsed solid tumor or AML | Experimental | Procedure: CancerSCAN™, Drug: Ifosfamide, Drug: Carboplatin, Drug: Etoposide, Drug: Fludarabine, Drug: Cytarabine, Drug: Pazopanib, Drug: Sorafenib, Drug: Axitinib, Drug: Crizotinib, Drug: Dasatinib, Drug: Erlotinib, Drug: Everolimus, Drug: Imatinib, Drug: Ruxolitinib, Drug: Vandetanib, Drug: Vemurafenib, Drug: TrastuzumabConventional chemotherapy (Ifosfamide carboplatin etoposide for solid tumor and fludarabine cytarabine for AML) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™ |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Under 18 years of age at initial diagnosis
- Patients with refractory/relapsed solid tumor or AML (Solid tumor: Stable or progressive disease after 1st-line treatment or relapse; AML: Persistence after 2 cycles of induction chemotherapy or relapse)
- Patient with tumor sample which is adequate for targeted deep sequencing
Key exclusion criteria (5 listed)
- Patients who had salvage chemotherapy previously
- Patients with organ dysfunction as follows (creatinine elevation ≥ 3 x upper limit of normal (ULN), ejection fraction <40%, significant arrhythmia or conduction disturbance)
- Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
- Patients whose tumor samples are not sufficient for targeted deep sequencing
- Pregnant or nursing women
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 |
|---|---|---|
| CancerSCAN™Targeted deep sequencing | Procedure or surgery | Refractory/relapsed solid tumor or AML |
| Ifosfamide | Drug | Refractory/relapsed solid tumor or AML |
| Carboplatin | Drug | Refractory/relapsed solid tumor or AML |
| Etoposide | Drug | Refractory/relapsed solid tumor or AML |
| Fludarabine | Drug | Refractory/relapsed solid tumor or AML |
| Cytarabine | Drug | Refractory/relapsed solid tumor or AML |
| Pazopanib | Drug | Refractory/relapsed solid tumor or AML |
| Sorafenib | Drug | Refractory/relapsed solid tumor or AML |
| Axitinib | Drug | Refractory/relapsed solid tumor or AML |
| Crizotinib | Drug | Refractory/relapsed solid tumor or AML |
| Dasatinib | Drug | Refractory/relapsed solid tumor or AML |
| Erlotinib | Drug | Refractory/relapsed solid tumor or AML |
| Everolimus | Drug | Refractory/relapsed solid tumor or AML |
| Imatinib | Drug | Refractory/relapsed solid tumor or AML |
| Ruxolitinib | Drug | Refractory/relapsed solid tumor or AML |
| Vandetanib | Drug | Refractory/relapsed solid tumor or AML |
| Vemurafenib | Drug | Refractory/relapsed solid tumor or AML |
| Trastuzumab | Drug | Refractory/relapsed solid tumor or AML |
Primary outcome
Rate of event free survival
Time frame: Up to 5 years
Event is defined as relapse, disease progression or treatment-related mortality.
1 secondary outcome
Rate of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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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.
Ki Woong Sung, MD, PhD principal investigator
Samsung Medical Center
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 CancerSCAN™, Ifosfamide and Carboplatin in people with Relapsed Pediatric Solid Tumor and Refractory Pediatric Solid Tumor, run by Samsung Medical Center 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 3 inclusion and 5 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 19 Mar 2020. 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 Ki Woong Sung, MD, PhD (82-2-3410-3529, kiwoong.sung@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of event free survival (time frame: Up to 5 years). 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 19 Mar 2020.