Pegteograstim in Children With Solid Tumors

Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors

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

Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.

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