Neutropenia Clinical Trial
Official title:
Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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