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NCT Number: NCT00003739

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

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.

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Key information

Conditions

Fever, Sweats, and Hot Flashes Agranulocytosis Body Temperature Changes Cytopenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Hot Flashes Leukocyte Disorders Leukopenia Neutropenia Pathological Conditions, Signs and Symptoms Signs and Symptoms Unspecified Childhood Solid Tumor, Protocol Specific

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sydney Children's Hospital, Randwick, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Primary outcomes

  1. Time to Resolution of Febrile Neutropenia

    Time to Resolution of Febrile Neutropenia (Days of antibiotic treatment until the resolution of febrile neutropenia): The time to resolution of febrile neutropenia is defined as the number of days elapsed before the first day with both a temperature of less than 38.0oC and an ANC of equal to or greater than 500/μL.

Secondary outcomes

  1. Incidence of Change of the Initial Empiric Antibiotic Treatment

    The Incidence of Change of the Initial Empiric Antibiotic Treatment: Any change in the initial empiric broad spectrum antibiotic treatment made during the febrile neutropenia period. There may be changes made in the antibiotic(s) after the resolution of febrile neutropenia.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia

Important dates

Study start
1999
Primary completion
2002
Study completion
2006
First posted
Jan 27, 2003
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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