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| 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 |
| 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 1999 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
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 |
DISEASE CHARACTERISTICS:
Histologically diagnosed cancer with fever and chemotherapy-induced neutropenia (absolute neutrophil count no greater than 500/mm3)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 235 Study Locations |
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | M. F. Ozkaynak, MD | New York Medical College |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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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.
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| 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 |
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