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

Children's Oncology Group67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Enrollment

Conditions

Fever, Sweats, and Hot Flashes Neutropenia

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (235)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

University of South Alabama Medical Center

Mobile, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arizona Cancer Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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 Outcomes

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.