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

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ClinicalTrials.gov Identifier: NCT02638428

Recruitment Status : Recruiting

First Posted : December 23, 2015

Last Update Posted : March 19, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Ministry of Health, Republic of Korea

Information provided by (Responsible Party):

Samsung Medical Center

Tracking Information

First Submitted Date ^ICMJE

November 29, 2015

First Posted Date ^ICMJE

December 23, 2015

Last Update Posted Date

March 19, 2020

Study Start Date ^ICMJE

December 2015

Estimated Primary Completion Date

December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rate of event free survival [ Time Frame: Up to 5 years ]

Event is defined as relapse, disease progression or treatment-related mortality.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Rate of treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 1 year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed 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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: CancerSCAN™
Targeted deep sequencing
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

Study Arms ^ICMJE

Experimental: 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™

Interventions:

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 2023

Estimated Primary Completion Date

December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

up to 18 Years (Child, Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Ki Woong Sung, MD, PhD

82-2-3410-3529

kiwoong.sung@samsung.com

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02638428

Other Study ID Numbers ^ICMJE

2015-08-008

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Samsung Medical Center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Ministry of Health, Republic of Korea

Investigators ^ICMJE

Principal Investigator:

Ki Woong Sung, MD, PhD

Samsung Medical Center

PRS Account

Samsung Medical Center

Verification Date

March 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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