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

NCT02638428 | Unknown Phase 2 DMC

• 1 other identifier: 2015-08-008
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Rate of event free survival

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

  Up to 5 years

Secondary Outcomes (1)

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

  Up to 1 year

Study Arms (1)

Refractory/relapsed solid tumor or AML

EXPERIMENTAL

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™; 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

Interventions

CancerSCAN™ PROCEDURE

Targeted deep sequencing

Refractory/relapsed solid tumor or AML

Ifosfamide DRUG

Refractory/relapsed solid tumor or AML

Carboplatin DRUG

Refractory/relapsed solid tumor or AML

Etoposide DRUG

Refractory/relapsed solid tumor or AML

Fludarabine DRUG

Refractory/relapsed solid tumor or AML

Cytarabine DRUG

Refractory/relapsed solid tumor or AML

Pazopanib DRUG

Refractory/relapsed solid tumor or AML

Sorafenib DRUG

Refractory/relapsed solid tumor or AML

Axitinib DRUG

Refractory/relapsed solid tumor or AML

Crizotinib DRUG

Refractory/relapsed solid tumor or AML

Dasatinib DRUG

Refractory/relapsed solid tumor or AML

Erlotinib DRUG

Refractory/relapsed solid tumor or AML

Everolimus DRUG

Refractory/relapsed solid tumor or AML

Imatinib DRUG

Refractory/relapsed solid tumor or AML

Ruxolitinib DRUG

Refractory/relapsed solid tumor or AML

Vandetanib DRUG

Refractory/relapsed solid tumor or AML

Vemurafenib DRUG

Refractory/relapsed solid tumor or AML

Trastuzumab DRUG

Refractory/relapsed solid tumor or AML

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Ifosfamide; Carboplatin; Etoposide; fludarabine; Cytarabine; pazopanib; Sorafenib; Axitinib; Crizotinib; Dasatinib; Erlotinib Hydrochloride; Everolimus; Imatinib Mesylate; ruxolitinib; vandetanib; Vemurafenib; Trastuzumab

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Aminopyridines; Thiazoles; Sulfur Compounds; Quinazolines; Sirolimus; Macrolides; Lactones; Piperazines; Sulfonamides; Sulfones; Indoles; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ki Woong Sung, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Woong Sung, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: December 23, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

KR (1)