Pegteograstim in Children With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-04

Study Completion Date

2018-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chemotherapy Induced Neutropenia Pediatric Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy induced neutropenia

Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle

Group Type EXPERIMENTAL

Pegteograstim

Intervention Type DRUG

Interventions

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Pegteograstim

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No