Pegteograstim in Children With Solid Tumors

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

Sponsors

Lead Sponsor: Samsung Medical Center

Collaborator: Green Cross Corporation

Source Samsung Medical Center
Brief Summary

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

Detailed Description

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.

Overall Status Unknown status
Start Date 2016-10-04
Completion Date 2018-11-01
Primary Completion Date 2018-10-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of adverse events Up to 3 weeks after the injection of pegteograsim
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL) Up to 6 weeks
Secondary Outcome
Measure Time Frame
Duration of severe neutropenia (ANC < 100/uL) Up to 6 weeks
Lowest value of ANC Up to 6 weeks
Days with neutropenic fever Up to 6 weeks
Enrollment 34
Condition
Intervention

Intervention Type: Drug

Intervention Name: Pegteograstim

Arm Group Label: Chemotherapy induced neutropenia

Eligibility

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Ki Woong Sung, MD, PhD

Phone: 82-2-3410-3529

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Samsung Medical Center Ki Woong Sung 82-2-3410-3529 [email protected] Ki Woong Sung Principal Investigator
Location Countries

Korea, Republic of

Verification Date

2017-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Chemotherapy induced neutropenia

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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