Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy

NCT ID: NCT02638428

Last Updated: 2020-03-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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™

Conditions

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Relapsed Pediatric Solid Tumor Refractory Pediatric Solid Tumor Relapsed Pediatric AML Refractory Pediatric AML

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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™

Group Type EXPERIMENTAL

CancerSCAN™

Intervention Type PROCEDURE

Targeted deep sequencing

Ifosfamide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Pazopanib

Intervention Type DRUG

Sorafenib

Intervention Type DRUG

Axitinib

Intervention Type DRUG

Crizotinib

Intervention Type DRUG

Dasatinib

Intervention Type DRUG

Erlotinib

Intervention Type DRUG

Everolimus

Intervention Type DRUG

Imatinib

Intervention Type DRUG

Ruxolitinib

Intervention Type DRUG

Vandetanib

Intervention Type DRUG

Vemurafenib

Intervention Type DRUG

Trastuzumab

Intervention Type DRUG

Interventions

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CancerSCAN™

Targeted deep sequencing

Intervention Type PROCEDURE

Ifosfamide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Pazopanib

Intervention Type DRUG

Sorafenib

Intervention Type DRUG

Axitinib

Intervention Type DRUG

Crizotinib

Intervention Type DRUG

Dasatinib

Intervention Type DRUG

Erlotinib

Intervention Type DRUG

Everolimus

Intervention Type DRUG

Imatinib

Intervention Type DRUG

Ruxolitinib

Intervention Type DRUG

Vandetanib

Intervention Type DRUG

Vemurafenib

Intervention Type DRUG

Trastuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ki Woong Sung, MD, PhD

Role: CONTACT

82-2-3410-3529

Facility Contacts

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Ki Woong Sung

Role: primary

82-2-3410-3529

Other Identifiers

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2015-08-008

Identifier Type: -

Identifier Source: org_study_id

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