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Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
Not Recruiting
Trial ID: NCT00003739
Purpose
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.
Official Title
Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
Stanford Investigator(s)
Eligibility
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
Intervention(s):
biological: filgrastim
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305