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

Samsung Medical Center90 enrolled

Overview

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 * 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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

CancerSCAN™PROCEDURE

Targeted deep sequencing

IfosfamideDRUG

CarboplatinDRUG

EtoposideDRUG

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Rate of event free survival

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

Time frame: Up to 5 years

Secondary Outcomes

Rate of treatment-related adverse events as assessed by CTCAE v4.0

Time frame: Up to 1 year

Central Contacts

Ki Woong Sung, MD, PhD

CONTACT

82-2-3410-3529 kiwoong.sung@samsung.com

Data from ClinicalTrials.gov

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