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Keep this study
Lead
Children's Oncology Group
With
National Cancer Institute (NCI)
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.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically diagnosed cancer with fever and chemotherapy-induced neutropenia (absolute neutrophil count no greater than 500/mm3)
* Acute onset of fever of at least 38.8 degrees Celsius that is not related to the administration of blood products or pyrogenic substances
No acute myelogenous leukemia
No myelodysplastic syndrome
No solid tumor with bone marrow involvement
PATIENT CHARACTERISTICS:
Age:
21 and under
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
See Disease Characteristics
Hepatic:
Creatinine less than 1.5 times upper limit of normal
Renal:
Not specified
Other:
No patients in septic shock
No prolonged fever of unknown origin
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
See Chemotherapy
Chemotherapy:
No prior or concurrent myeloablative chemoradiotherapy with bone marrow or peripheral stem cell rescue
Endocrine therapy:
Not specified
Radiotherapy:
See Chemotherapy
No prior radiotherapy to marrow reserves (i.e., craniospinal and/or pelvic irradiation)
Surgery:
Not specified
Other:
At least 7 days since prior IV antibiotics
Clareo Health | Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
