Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
filgrastim
Cytopenia+9
+ Agranulocytosis
+ Body Temperature Changes
Supportive Care Study
Summary
Study start date: March 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.67 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 235 locations
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google MapsUniversity of South Alabama Medical Center
Mobile, United StatesPhoenix Children's Hospital
Phoenix, United StatesArizona Cancer Center
Tucson, United States