Pegteograstim in Children With Solid Tumors

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

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

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: Green Cross Corporation

Criteria

Inclusion Criteria:

• Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen

Exclusion Criteria:

• Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)

• Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.

• Patients with bleeding tendency to whom subcutaneous injection should be avoided.

• Active infection or infectious fever during the screening period.

• Genetic problem to fructose tolerance.

• Patients who participated in other clinical trial within 4 weeks before enrollment.

• Pregnant and nursing women