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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003739 |
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 |
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Cancer-Related Problem/Condition Unspecified Childhood Solid Tumor, Protocol Specific |
Biological: filgrastim |
Phase III |
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.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
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:
Study Chair: | M. F. Ozkaynak, MD | New York Medical College |
Study ID Numbers: | CDR0000066854, COG-AS973, COG-S9703, CCG-S9703, COG-973, NCI-P99-0140 |
Study First Received: | November 1, 1999 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00003739 History of Changes |
Health Authority: | United States: Federal Government |
unspecified childhood solid tumor, protocol specific fever, sweats, and hot flashes neutropenia |
Fever Anti-Bacterial Agents Neutropenia Hematologic Diseases Agranulocytosis |
Hot Flashes Leukocyte Disorders Leukopenia Granulocytopenia |
Anti-Infective Agents Anti-Bacterial Agents Neutropenia Hematologic Diseases Therapeutic Uses |
Agranulocytosis Leukocyte Disorders Leukopenia Pharmacologic Actions |