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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.
Study NCT00003739   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: May 9, 2009   History of Changes

November 1, 1999
May 9, 2009
March 1999
 
 
 
Complete list of historical versions of study NCT00003739 on ClinicalTrials.gov Archive Site
 
 
 
Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
Randomized Comparison Between Antiobiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia

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.

Phase III
Interventional
Supportive Care, Randomized
  • Fever, Sweats, and Hot Flashes
  • Neutropenia
  • Unspecified Childhood Solid Tumor, Protocol Specific
Biological: filgrastim
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
 
 

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00003739
 
CDR0000066854, COG-AS973, COG-S9703, CCG-S9703, COG-973, NCI-P99-0140
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: M. F. Ozkaynak, MD New York Medical College
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP