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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neutropenia, Fever, Sweats, and Hot Flashes, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Resolution of Febrile Neutropenia | Time to Resolution of Febrile Neutropenia (Days of antibiotic treatment until the resolution of febrile neutropenia): The time to resolution of febrile neutropenia is defined as the number of days elapsed before the first day with both a temperature of less than 38.0oC and an ANC of equal to or greater than 500/μL. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Change of the Initial Empiric Antibiotic Treatment | The Incidence of Change of the Initial Empiric Antibiotic Treatment: Any change in the initial empiric broad spectrum antibiotic treatment made during the febrile neutropenia period. There may be changes made in the antibiotic(s) after the resolution of febrile neutropenia. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutropenia, unspecified childhood solid tumor, protocol specific, fever, sweats, and hot flashes