Trial record 12 of 236 for:    "cyclic neutropenia" OR "Neutropenia"

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00003739
First received: November 1, 1999
Last updated: February 12, 2014
Last verified: February 2014
  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 3

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:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Time to Resolution of Febrile Neutropenia [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Incidence of Change of the Initial Empiric Antibiotic Treatment [ Designated as safety issue: No ]
    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.


Enrollment: 67
Study Start Date: March 1999
Study Completion Date: September 2006
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003739

  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: M. F. Ozkaynak, MD New York Medical College
  More Information

Additional Information:
Publications:
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.

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003739     History of Changes
Other Study ID Numbers: AS973, COG-AS973, COG-S9703, CCG-S9703, COG-973, NCI-P99-0140, CDR0000066854
Study First Received: November 1, 1999
Last Updated: February 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
unspecified childhood solid tumor, protocol specific
fever, sweats, and hot flashes
neutropenia

Additional relevant MeSH terms:
Neutropenia
Fever
Hot Flashes
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Lenograstim
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014