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| Name | Class |
|---|---|
| Ministry of Health, Republic of Korea | OTHER_GOV |
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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, CancerSCANâ„¢, which can detect clinically significant genomic aberrations of tumors. In this study, tumor samples of refractory/relapsed pediatric cancer patients will be tested with CancerSCANâ„¢ and the patients will receive combination chemotherapy with matched single-targeted agent or multi-targeted receptor tyrosine kinase inhibitor according to the result of CancerSCANâ„¢.
I. Relapsed/refractory solid tumor
II. Relapsed/refractory AML
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 CancerSCANâ„¢ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CancerSCANâ„¢ | Procedure | Targeted deep sequencing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of event free survival | Event is defined as relapse, disease progression or treatment-related mortality. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment-related adverse events as assessed by CTCAE v4.0 | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ki Woong Sung, MD, PhD | Contact | 82-2-3410-3529 | kiwoong.sung@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Ki Woong Sung, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| 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 | Drug |
|
| ID | Term |
|---|---|
| D007069 | Ifosfamide |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| C024352 | fludarabine |
| D003561 | Cytarabine |
| C516667 | pazopanib |
| D000077157 | Sorafenib |
| D000077784 | Axitinib |
| D000077547 | Crizotinib |
| D000069439 | Dasatinib |
| D000069347 | Erlotinib Hydrochloride |
| D000068338 | Everolimus |
| D000068877 | Imatinib Mesylate |
| C540383 | ruxolitinib |
| C452423 | vandetanib |
| D000077484 | Vemurafenib |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D001549 | Benzamides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |
| D000631 | Aminopyridines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D011799 | Quinazolines |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D010879 | Piperazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D007211 | Indoles |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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