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Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia (NCT00003739)

National Cancer Institute (NCI)
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.
  • Biological: filgrastim
    Ages eligible for Study
    up to 21 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    235 locations

    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    28 February, 1999
    Updated:
    11 February, 2014
    Participants:
    67
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