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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
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
 (submitted: December 20, 2015)
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
 (submitted: December 20, 2015)
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
 (submitted: December 20, 2015)
90
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 No
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