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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on November 1, 1999. Last Updated on February 12, 2010 History of Changes

Sponsor:	Children's Oncology Group
Collaborator:	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	Biological: filgrastim	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Antibiotics Cancer Fever Sweat

Drug Information available for: Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

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

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

M. F. Ozkaynak, MD

New York Medical College

More Information

Additional Information:

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

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00003739 History of Changes
Other Study ID Numbers:	CDR0000066854, COG-AS973, COG-S9703, CCG-S9703, COG-973, NCI-P99-0140
Study First Received:	November 1, 1999
Last Updated:	February 12, 2010
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

Additional relevant MeSH terms:

Fever
Neutropenia
Hot Flashes
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

Anti-Bacterial Agents
Lenograstim
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012