Pegteograstim in Children With Solid Tumors

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02787876
• Collaborator: Green Cross Corporation (Industry)
• Enrollment: 34
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy Induced Neutropenia; Pediatric Solid Tumor	Drug: Pegteograstim	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
• Actual Study Start Date: Oct 4, 2016
• Anticipated Primary Completion Date: Oct 1, 2018
• Anticipated Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy induced neutropenia Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle	Drug: Pegteograstim

Outcome Measures

Primary Outcome Measures

1. Rate of adverse events [Up to 3 weeks after the injection of pegteograsim]

2. Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL) [Up to 6 weeks]

Secondary Outcome Measures

1. Duration of severe neutropenia (ANC < 100/uL) [Up to 6 weeks]

2. Lowest value of ANC [Up to 6 weeks]

3. Days with neutropenic fever [Up to 6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center
• Green Cross Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02787876
• Other Study ID Numbers: 2015-12-121
• First Posted: Jun 1, 2016
• Last Update Posted: Sep 18, 2018
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Neutropenia

Study Results

No Results Posted as of Sep 18, 2018