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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 : September 18, 2018
Sponsor:
Collaborator:
Ministry of Health, Republic of Korea
Information provided by (Responsible Party):
Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Relapsed Pediatric Solid Tumor Refractory Pediatric Solid Tumor Relapsed Pediatric AML Refractory Pediatric AML 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 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy
Study Start Date : December 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
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™
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



Primary Outcome Measures :
  1. Rate of event free survival [ Time Frame: Up to 5 years ]
    Event is defined as relapse, disease progression or treatment-related mortality.


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


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638428


Contacts
Contact: Ki Woong Sung, MD, PhD 82-2-3410-3529 kiwoong.sung@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Ki Woong Sung    82-2-3410-3529    kwsped@skku.edu   
Principal Investigator: Ki Woong Sung         
Sponsors and Collaborators
Samsung Medical Center
Ministry of Health, Republic of Korea
Investigators
Principal Investigator: Ki Woong Sung, MD, PhD Samsung Medical Center

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02638428     History of Changes
Other Study ID Numbers: 2015-08-008
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Fludarabine phosphate
Sorafenib
Etoposide phosphate
Isophosphamide mustard
Vemurafenib
Carboplatin
Trastuzumab
Everolimus
Sirolimus
Erlotinib Hydrochloride
Etoposide
Cytarabine
Imatinib Mesylate
Dasatinib
Ifosfamide
Axitinib
Crizotinib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents