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

Sponsor
Samsung Medical Center
Study ID
NCT02638428
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • CancerSCAN™ — PROCEDURE
    Targeted deep sequencing
  • 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 — DRUG

Study Details

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.

Key Dates

Start date
Dec 31, 2015
Status verified
Mar 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2023

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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™

Primary Outcome Measure

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

Central Contacts