A Phase 2 interventional study of CancerSCAN™ and Ifosfamide in Relapsed Pediatric Solid Tumor, Refractory Pediatric Solid Tumor and Relapsed Pediatric AML, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment
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.
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
II. Relapsed/refractory AML
2,443 studies on the registry are indexed under Leukemia, Myeloid; 210 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 1,977 interventional studies indexed under Leukemia, Myeloid.
Browse Leukemia, Myeloid studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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™
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
Targeted deep sequencing
Rate of event free survival
Event is defined as relapse, disease progression or treatment-related mortality.
Time frame: Up to 5 years
Rate of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 1 year
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center