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Clinical 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.


Clinical Trial 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™.

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™ ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02638428
Study type Interventional
Source Samsung Medical Center
Contact Ki Woong Sung, MD, PhD
Phone 82-2-3410-3529
Email kiwoong.sung@samsung.com
Status Recruiting
Phase Phase 2
Start date December 2015
Completion date December 2023

See also
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Completed NCT04562792 - Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia Phase 2
Withdrawn NCT05622591 - ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML Phase 1
Approved for marketing NCT03245424 - Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation