Clinical Trials Directory

Trials / Completed

CompletedNCT00003739

Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy

Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
67 (actual)
Sponsor
Children's Oncology Group · Network
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus G-CSF is more effective than antibiotic therapy alone for treating side effects caused by chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy.

Detailed description

OBJECTIVES: * Determine whether filgrastim (G-CSF) used in addition to standard antibiotic therapy accelerates time to resolution of febrile neutropenia in children receiving chemotherapy. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive standard antibiotic therapy. * Arm II: Patients receive treatment as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously or IV once a day until at least 2 consecutive afebrile days have passed and absolute neutrophil count is at least 500/mm3. Patients are followed for 3 days. PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.

Conditions

Interventions

TypeNameDescription
BIOLOGICALfilgrastim

Timeline

Start date
1999-03-01
Primary completion
2002-12-01
Completion
2006-09-01
First posted
2003-01-27
Last updated
2014-02-14

Locations

235 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland

Source: ClinicalTrials.gov record NCT00003739. Inclusion in this directory is not an endorsement.