Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy
NCT ID: NCT02638428
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2015-12-31
2023-12-31
Brief Summary
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Detailed Description
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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™.
I. 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Refractory/relapsed solid tumor or AML
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™
CancerSCAN™
Targeted deep sequencing
Ifosfamide
Carboplatin
Etoposide
Fludarabine
Cytarabine
Pazopanib
Sorafenib
Axitinib
Crizotinib
Dasatinib
Erlotinib
Everolimus
Imatinib
Ruxolitinib
Vandetanib
Vemurafenib
Trastuzumab
Interventions
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CancerSCAN™
Targeted deep sequencing
Ifosfamide
Carboplatin
Etoposide
Fludarabine
Cytarabine
Pazopanib
Sorafenib
Axitinib
Crizotinib
Dasatinib
Erlotinib
Everolimus
Imatinib
Ruxolitinib
Vandetanib
Vemurafenib
Trastuzumab
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, Republic of Korea
OTHER_GOV
Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ki Woong Sung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-08-008
Identifier Type: -
Identifier Source: org_study_id
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