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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: 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.


Condition Intervention Phase
Fever, Sweats, and Hot Flashes
Neutropenia
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: filgrastim
Phase III

MedlinePlus related topics:   Antibiotics    Cancer    Fever    Sweat   

ChemIDplus related topics:   Filgrastim    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Granulocyte colony-stimulating factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized
Official Title:   Randomized Comparison Between Antiobiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   200
Study Start Date:   March 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003739

Show 235 study locations  Show 235 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     M. F. Ozkaynak, MD     New York Medical College    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Ozkaynak MF, Krailo M, Chen Z, Feusner J. Randomized comparison of antibiotics with and without granulocyte colony-stimulating factor in children with chemotherapy-induced febrile neutropenia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2005 Sep;45(3):274-80.
 
Ozkaynak MF, Krailo M, Chen N, et al.: Randomized comparison of antibiotics alone and with granulocyte colony-stimulating factor (G-CSF) in children with chemotherapy-induced febrile neutropenia: a report from the Children's Oncology Group. [Abstract] 2004 Pediatric Academic Societies' Annual Meeting, May 1-4, San Francisco, California. A-1769, 2004. Available online Last accessed August 29, 2005.

Study ID Numbers:   CDR0000066854, COG-AS973, COG-S9703, CCG-S9703, COG-973, NCI-P99-0140
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003739
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific  
fever, sweats, and hot flashes  
neutropenia  

Study placed in the following topic categories:
Fever
Signs and Symptoms
Neutropenia
Hematologic Diseases
Agranulocytosis
Hot Flashes
Leukocyte Disorders
Leukopenia
Granulocytopenia

Additional relevant MeSH terms:
Body Temperature Changes

ClinicalTrials.gov processed this record on August 20, 2008




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