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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborators: Ministry of health & welfare, Republic of Korea; Ministry of Health, Republic of Korea
• Treatments: Axitinib; Carboplatin; Crizotinib; Cytarabine; Dasatinib; Erlotinib Hydrochloride; Etoposide; Etoposide phosphate; Everolimus; Fludarabine; Fludarabine phosphate; Ifosfamide; Imatinib Mesylate; Isophosphamide mustard; Sirolimus; Sorafenib; Trastuzumab; Vemurafenib

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