Fever, Sweats, and Hot FlashesPhase 3NCT00003739
Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
A Phase 3 study testing filgrastim in people with Fever, Sweats, and Hot Flashes and Neutropenia, run by Children's Oncology Group at 235 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Fever, Sweats, and Hot Flashes, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- filgrastim
- How many people
- 67 participants
- Where
- 235 sitesin 7 countries
- Study dates
- Mar 1999to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
235 sites in 7 countries.
235 sites in 7 countries
United States206 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Cancer Center of Albany Medical Center
Albany, New York, 12208
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, 79106
Mott Children's Hospital
Ann Arbor, Michigan, 48109-0914
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, 30912-4000
Children's Hospital of Austin
Austin, Texas, 78701
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201-1595
Sinai Hospital of Baltimore
Baltimore, Maryland, 21225
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Eastern Maine Medical Center
Bangor, Maine, 04401
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35233
Mountain States Tumor Institute
Boise, Idaho, 83712
Floating Hospital for Children
Boston, Massachusetts, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Brooklyn Hospital Center
Brooklyn, New York, 11201
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, 11203
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Maimonides Medical Center
Brooklyn, New York, 11219
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
West Virginia University - Charleston
Charleston, West Virginia, 25302
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
University of Chicago Cancer Research Center
Chicago, Illinois, 60601
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, 29203
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
Medical City Dallas Hospital
Dallas, Texas, 75230
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Geisinger Medical Center
Danville, Pennsylvania, 17822-1320
Children's Medical Center - Dayton
Dayton, Ohio, 45404
Children's Hospital of Denver
Denver, Colorado, 80218-1088
Childhood Hematology/Oncology Associates
Denver, Colorado, 80218
Presbyterian-St Luke's Medical Center
Denver, Colorado, 80218
Raymond Blank Memorial Hospital for Children
Des Moines, Iowa, 50308
John Stoddard Cancer Center
Des Moines, Iowa, 50309
Children's Hospital of Michigan
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Southern California Permanente Medical Group
Downey, California, 90242
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, 55805-1983
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Michigan State University
East Lansing, Michigan, 48824
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
Dakota Cancer Institute
Fargo, North Dakota, 58103-4940
University of Connecticut Health Center
Farmington, Connecticut, 06360-7106
Hurley Medical Center
Flint, Michigan, 48503
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
University of Texas Medical Branch
Galveston, Texas, 77555-0361
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
St. Vincent Hospital
Green Bay, Wisconsin, 54307-9070
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, 33021
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Baylor College of Medicine
Houston, Texas, 77030
Cabell-Huntington Hospital, Inc
Huntington, West Virginia, 25701
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
St. Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Nemours Children's Clinic
Jacksonville, Florida, 32207
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, 37604
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Children's Mercy Hospital
Kansas City, Missouri, 64108
East Tennessee Children's Hospital
Knoxville, Tennessee, 37901
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109-2306
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0284
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Loma Linda University Medical Center
Loma Linda, California, 92354
Jonathan Jaques Children's Cancer Center
Long Beach, California, 90801-1428
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Kosair Children's Hospital
Louisville, Kentucky, 40202-3830
Covenant Children's Hospital
Lubbock, Texas, 79410
Medical Center of Central Georgia
Macon, Georgia, 31201
Children's Hospital Central California
Madera, California, 93638-8762
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-0001
North Shore University Hospital
Manhasset, New York, 11030
Marshfield Clinic
Marshfield, Wisconsin, 54449-5772
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
University of Miami-Jackson Memorial Hospital
Miami, Florida, 33136
Miami Children's Hospital
Miami, Florida, 33155-4069
Baptist Hospital of Miami
Miami, Florida, 33176-2197
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, 55404
University of South Alabama Medical Center
Mobile, Alabama, 36604
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
Schneider Children's Hospital
New Hyde Park, New York, 11042
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Ochsner Clinic
New Orleans, Louisiana, 70121
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021-4885
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Columbia Presbyterian Hospital
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112-2094
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital of Oakland
Oakland, California, 94609-1809
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104
Children's Hospital of Omaha
Omaha, Nebraska, 68114
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2168
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Children's Hospital of Orange County
Orange, California, 92868
Florida Hospital Cancer Institute
Orlando, Florida, 32803
Nemours Children's Clinic-Orlando
Orlando, Florida, 32806
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Lutheran General Hospital
Park Ridge, Illinois, 60068-1174
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
Sacred Heart Children's Hospital
Pensacola, Florida, 32504
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
Phoenix Children's Hospital
Phoenix, Arizona, 85016-7710
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-5100
Rhode Island Hospital
Providence, Rhode Island, 02818
Massey Cancer Center
Richmond, Virginia, 23298-0037
Carilion Medical Center for Children
Roanoke, Virginia, 24013
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
James P. Wilmot Cancer Center
Rochester, New York, 14642
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
William Beaumont Hospital
Royal Oak, Michigan, 48073-6769
Sutter Cancer Center
Sacramento, California, 95816
University of California Davis Medical Center
Sacramento, California, 95817
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
Methodist Health Care System
San Antonio, Texas, 78229-3902
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, 92120
Children's Hospital San Diego
San Diego, California, 92123-4282
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, 94115
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386
Memorial Health University Medical Center, Inc.
Savannah, Georgia, 31403-3089
Maine Children's Cancer Program
Scarborough, Maine, 04074
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Group Health Cooperative
Seattle, Washington, 98112
Avera Cancer Institute
Sioux Falls, South Dakota, 57105-1080
Sioux Valley Hospital
Sioux Falls, South Dakota, 57117
Deaconess Medical Center
Spokane, Washington, 99210-0248
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9658
Baystate Medical Center
Springfield, Massachusetts, 01107
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
St. Louis Children's Hospital
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
Atlantic Health System
Summit, New Jersey, 07901
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Mary Bridge Children's Health Center
Tacoma, Washington, 98415-0299
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
Tampa Children's Hospital
Tampa, Florida, 33677-4227
Scott and White Memorial Hospital
Temple, Texas, 76508
Albert Einstein Clinical Cancer Center
The Bronx, New York, 10461
Toledo Children's Hospital
Toledo, Ohio, 43601
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
David Grant Medical Center
Travis Air Force Base, California, 94535
Arizona Cancer Center
Tucson, Arizona, 85724
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
New York Medical College
Valhalla, New York, 10595
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
St. Mary's Hospital
West Palm Beach, Florida, 33407
Wesley Medical Center
Wichita, Kansas, 67214
Alfred I. Dupont Institute
Wilmington, Delaware, 19899
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1081
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Forum Health-Tod Childrens Hospital
Youngstown, Ohio, 44501
Canada16 sites
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Children's Hospital
Hamilton, Ontario, L8N 3Z5
Children's Hospital of Western Ontario
London, Ontario, N6C 2V5
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Laval University Medical Center
Sainte-Foy, Quebec, G1V 4G2
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, GIV 4G2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Australia6 sites
Royal Children's Hospital
Brisbane, Queensland, 4029
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Royal Children's Hospital
Parkville, Victoria, 3052
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Sydney Children's Hospital
Randwick, New South Wales, 2031
Children's Hospital at Westmead
Westmead, New South Wales, 2145
Switzerland3 sites
Swiss Pediatric Oncology Group Bern
Bern, CH 3010
Swiss Pediatric Oncology Group Geneva
Geneva, CH 1211
Swiss Pediatric Oncology Group Lausanne
Lausanne, CH 1011
Puerto Rico2 sites
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067
San Jorge Childrens Hospital
Santurce, 00912
About this study
Official title: Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
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.
Read the 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.
- Conditions
- Fever, Sweats, and Hot Flashes, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- filgrastim
- Keywords
- unspecified childhood solid tumor, protocol specific, fever, sweats, and hot flashes, neutropenia
- Medical subject headings
- Fever, Hot Flashes, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 1999
- Primary completionDec 2002
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fever, Sweats, and Hot FlashesStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- M. F. Ozkaynak, MD, Study chair, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003739
- Sponsor's protocol ID
- AS973
- Other IDs
- COG-AS973, COG-S9703, CCG-S9703, COG-973, NCI-P99-0140, CDR0000066854
- Status last verified
- Feb 2014
- First submitted
- 1 Nov 1999
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1002/pbc.20366.
PubMed 15806544
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT00003739
- Acronym / sponsor ID
- AS973
- Conditions
- Fever, Sweats, and Hot Flashes, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- unspecified childhood solid tumor, protocol specific, fever, sweats, and hot flashes, neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1999
- Primary completion
- Dec 2002 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
Primary outcome
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.
1 secondary outcome
Incidence of Change of the Initial Empiric Antibiotic Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
- Results publication: PubMed 15806544Ozkaynak 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. doi: 10.1002/pbc.20366.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. F. Ozkaynak, MD study chair
New York Medical College
235 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filgrastim in people with Fever, Sweats, and Hot Flashes and Neutropenia, run by Children's Oncology Group at 235 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 235 sites in United States, Canada, Australia, Switzerland, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of Febrile Neutropenia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.