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Clinical Trial: Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
This study is no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| unspecified childhood solid tumor, protocol specific fever, sweats, and hot flashes Neutropenia | Drug: filgrastim Procedure: complications of therapy assessment/management Procedure: hematologic toxicity attenuation Procedure: supportive care/therapy | Phase III |
MedlinePlus related topics: Blood and Blood Disorders; Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Standard Antibiotic Therapy With or Without Filgrastim (G-CSF) in Children With Chemotherapy-Induced Febrile Neutropenia
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
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
Location Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35233, United States
University of South Alabama Medical Center, Mobile, Alabama, 36604, United States
Arizona
Arizona Cancer Center, Tucson, Arizona, 85724, United States
Phoenix Children's Hospital, Phoenix, Arizona, 85016-7710, United States
Arkansas
University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States
California
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
Chao Family Comprehensive Cancer Center, Orange, California, 92868, United States
Children's Hospital Central California, Madera, California, 93638-8762, United States
Children's Hospital Los Angeles, Los Angeles, California, 90027-0700, United States
Children's Hospital of Oakland, Oakland, California, 94609-1809, United States
Children's Hospital of Orange County, Orange, California, 92868, United States
Children's Hospital San Diego, San Diego, California, 92123-4282, United States
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States
David Grant Medical Center, Travis Air Force Base, California, 94535, United States
Jonathan Jaques Children's Cancer Center, Long Beach, California, 90801-1428, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus, San Francisco, California, 94115, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051-5386, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, 92120, United States
Loma Linda University Medical Center, Loma Linda, California, 92354, United States
Lucile Packard Children's Hospital at Stanford, Palo Alto, California, 94304, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States
Santa Barbara Cottage Hospital, Santa Barbara, California, 93102, United States
Southern California Permanente Medical Group, Downey, California, 90242, United States
Sutter Cancer Center, Sacramento, California, 95816, United States
UCSF Comprehensive Cancer Center, San Francisco, California, 94143-0128, United States
University of California Davis Medical Center, Sacramento, California, 95817, United States
Colorado
Childhood Hematology/Oncology Associates, Denver, Colorado, 80218, United States
Children's Hospital of Denver, Denver, Colorado, 80218-1088, United States
Presbyterian-St Luke's Medical Center, Denver, Colorado, 80218, United States
Connecticut
University of Connecticut Health Center, Farmington, Connecticut, 06360-7106, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, 06520-8028, United States
Delaware
Alfred I. Dupont Institute, Wilmington, Delaware, 19899, United States
District of Columbia
Children's National Medical Center, Washington, District of Columbia, 20010-2970, United States
Lombardi Cancer Center, Washington, District of Columbia, 20007, United States
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5000, United States
Florida
All Children's Hospital, St. Petersburg, Florida, 33701, United States
Baptist Hospital of Miami, Miami, Florida, 33176-2197, United States
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States
Children's Hospital of Southwest Florida, Fort Myers, Florida, 33908, United States
Florida Hospital Cancer Institute, Orlando, Florida, 32803, United States
Joe DiMaggio Children's Hospital at Memorial, Hollywood, Florida, 33021, United States
Miami Children's Hospital, Miami, Florida, 33155-4069, United States
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States
Nemours Children's Clinic-Orlando, Orlando, Florida, 32806, United States
Sacred Heart Children's Hospital, Pensacola, Florida, 32504, United States
Shands Hospital and Clinics, University of Florida, Gainesville, Florida, 32610-100277, United States
St. Mary's Hospital, West Palm Beach, Florida, 33407, United States
Tampa Children's Hospital, Tampa, Florida, 33677-4227, United States
University of Miami-Jackson Memorial Hospital, Miami, Florida, 33136, United States
Georgia
Children's Healthcare of Atlanta - Scottish Rite, Atlanta, Georgia, 30342, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, 30322, United States
Medical Center of Central Georgia, Macon, Georgia, 31201, United States
Medical College of Georgia Comprehensive Cancer Center, Augusta, Georgia, 30912-4000, United States
Memorial Health University Medical Center, Inc., Savannah, Georgia, 31403-3089, United States
Hawaii
Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States
Tripler Army Medical Center, Honolulu, Hawaii, 96859-5000, United States
Idaho
Mountain States Tumor Institute, Boise, Idaho, 83712, United States
Illinois
Children's Memorial Hospital - Chicago, Chicago, Illinois, 60614, United States
Hope Children's Hospital, Oak Lawn, Illinois, 60453, United States
Lutheran General Hospital, Park Ridge, Illinois, 60068-1174, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, 60612, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, 61637, United States
Southern Illinois University School of Medicine, Springfield, Illinois, 62794-9658, United States
University of Chicago Cancer Research Center, Chicago, Illinois, 60601, United States
University of Illinois at Chicago, Chicago, Illinois, 60612, United States
Indiana
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States
St. Vincent Hospital and Health Care Center, Indianapolis, Indiana, 46260, United States
Iowa
Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242-1009, United States
John Stoddard Cancer Center, Des Moines, Iowa, 50309, United States
Raymond Blank Memorial Hospital for Children, Des Moines, Iowa, 50308, United States
Kansas
Wesley Medical Center, Wichita, Kansas, 67214, United States
Kentucky
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, 40536-0284, United States
Kosair Children's Hospital, Louisville, Kentucky, 40202-3830, United States
Louisiana
Children's Hospital of New Orleans, New Orleans, Louisiana, 70118, United States
Ochsner Clinic, New Orleans, Louisiana, 70121, United States
Tulane University School of Medicine, New Orleans, Louisiana, 70112, United States
Maine
Eastern Maine Medical Center, Bangor, Maine, 04401, United States
Maine Children's Cancer Program, Scarborough, Maine, 04074, United States
Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, 21201-1595, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, 21225, United States
Massachusetts
Baystate Medical Center, Springfield, Massachusetts, 01107, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States
Floating Hospital for Children, Boston, Massachusetts, 02111, United States
University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts, 01655, United States
Michigan
Bronson Methodist Hospital, Kalamazoo, Michigan, 49007, United States
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States
Children's Hospital of Michigan, Detroit, Michigan, 48201, United States
Henry Ford Hospital, Detroit, Michigan, 48202, United States
Hurley Medical Center, Flint, Michigan, 48503, United States
Michigan State University, East Lansing, Michigan, 48824, United States
Mott Children's Hospital, Ann Arbor, Michigan, 48109-0914, United States
Spectrum Health and DeVos Children's Hospital, Grand Rapids, Michigan, 49503, United States
St. John Hospital and Medical Center, Detroit, Michigan, 48236, United States
William Beaumont Hospital, Royal Oak, Michigan, 48073-6769, United States
Minnesota
Children's Hospitals and Clinics - Minneapolis, Minneapolis, Minnesota, 55404, United States
Children's Hospitals and Clinics of Minnesota, Saint Paul, Minnesota, 55102, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States
St. Mary's/Duluth Clinic Cancer Center, Duluth, Minnesota, 55805-1983, United States
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States
Missouri
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, 63104, United States
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States
St. Louis Children's Hospital, Saint Louis, Missouri, 63110, United States
Nebraska
Children's Hospital of Omaha, Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center, Omaha, Nebraska, 68198-2168, United States
Nevada
Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109-2306, United States
New Hampshire
Norris Cotton Cancer Center, Lebanon, New Hampshire, 03756-0002, United States
New Jersey
Atlantic Health System, Summit, New Jersey, 07901, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, 08903, United States
Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States
Newark Beth Israel Medical Center, Newark, New Jersey, 07112-2094, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, 07503, United States
New Mexico
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, 87131, United States
New York
Albert Einstein Clinical Cancer Center, Bronx, New York, 10461, United States
Brookdale University Hospital and Medical Center, Brooklyn, New York, 11212, United States
Brooklyn Hospital Center, Brooklyn, New York, 11201, United States
Cancer Center of Albany Medical Center, Albany, New York, 12208, United States
Columbia Presbyterian Hospital, New York, New York, 10032, United States
James P. Wilmot Cancer Center, Rochester, New York, 14642, United States
Maimonides Medical Center, Brooklyn, New York, 11219, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States
Mount Sinai School of Medicine, New York, New York, 10029, United States
New York Medical College, Valhalla, New York, 10595, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, 10021-4885, United States
North Shore University Hospital, Manhasset, New York, 11030, United States
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States
Schneider Children's Hospital, New Hyde Park, New York, 11042, United States
State University of New York - Upstate Medical University, Syracuse, New York, 13210, United States
State University of New York Health Science Center at Brooklyn College of Medicine, Brooklyn, New York, 11203, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, 11790-7775, United States
North Carolina
Carolinas Medical Center, Charlotte, North Carolina, 28232-2861, United States
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1081, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States
East Carolina University School of Medicine, Greenville, North Carolina, 27858-4354, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, 27599-7295, United States
Mission Saint Joseph's Health System, Asheville, North Carolina, 28801, United States
Presbyterian Healthcare, Charlotte, North Carolina, 28233-3549, United States
North Dakota
Dakota Cancer Institute, Fargo, North Dakota, 58103-4940, United States
Ohio
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, 45229-3039, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, 44308, United States
Children's Hospital of Columbus, Columbus, Ohio, 43205-2696, United States
Children's Medical Center - Dayton, Dayton, Ohio, 45404, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States
Forum Health-Tod Childrens Hospital, Youngstown, Ohio, 44501, United States
Ireland Cancer Center, Cleveland, Ohio, 44106-5065, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, 43608, United States
Toledo Children's Hospital, Toledo, Ohio, 43601, United States
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States
Children's Hospital of Oklahoma, Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, 74136, United States
Oregon
Doernbecher Children's Hospital, Portland, Oregon, 97201-3098, United States
Legacy Emanuel Hospital and Health Center, Portland, Oregon, 97227, United States
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States
Geisinger Medical Center, Danville, Pennsylvania, 17822-1320, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States
St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, 19134-1095, United States
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02818, United States
South Carolina
Children's Hospital of Greenville Hospital System, Greenville, South Carolina, 29605, United States
Medical University of South Carolina, Charleston, South Carolina, 29425-0721, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, 29203, United States
South Dakota
Avera Cancer Institute, Sioux Falls, South Dakota, 57105-1080, United States
Sioux Valley Hospital, Sioux Falls, South Dakota, 57117, United States
Tennessee
East Tennessee Children's Hospital, Knoxville, Tennessee, 37901, United States
East Tennessee State University Cancer Center at JCMC, Johnson City, Tennessee, 37604, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, 38105-2794, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232-6838, United States
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States
Children's Hospital of Austin, Austin, Texas, 78701, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, 76104, United States
Covenant Children's Hospital, Lubbock, Texas, 79410, United States
Medical City Dallas Hospital, Dallas, Texas, 75230, United States
Methodist Health Care System, San Antonio, Texas, 78229-3902, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas, 78236-5300, United States
Scott and White Memorial Hospital, Temple, Texas, 76508, United States
Simmons Cancer Center - Dallas, Dallas, Texas, 75235-9154, United States
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, 79106, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030-4009, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78207, United States
University of Texas Medical Branch, Galveston, Texas, 77555-0361, United States
Utah
Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States
Vermont
Vermont Cancer Center, Burlington, Vermont, 05401-3498, United States
Virginia
Cancer Center at the University of Virginia, Charlottesville, Virginia, 22908, United States
Carilion Medical Center for Children, Roanoke, Virginia, 24013, United States
Children's Hospital of the King's Daughters, Norfolk, Virginia, 23507, United States
Inova Fairfax Hospital, Falls Church, Virginia, 22042-3300, United States
Massey Cancer Center, Richmond, Virginia, 23298-0037, United States
Naval Medical Center, Portsmouth, Portsmouth, Virginia, 23708-5100, United States
Washington
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, 98105, United States
Deaconess Medical Center, Spokane, Washington, 99210-0248, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024, United States
Group Health Cooperative, Seattle, Washington, 98112, United States
Madigan Army Medical Center, Tacoma, Washington, 98431-5000, United States
Mary Bridge Children's Health Center, Tacoma, Washington, 98415-0299, United States
West Virginia
Cabell-Huntington Hospital, Inc, Huntington, West Virginia, 25701, United States
West Virginia University - Charleston, Charleston, West Virginia, 25302, United States
West Virginia University Hospitals, Morgantown, West Virginia, 26506-9300, United States
Wisconsin
Bellin Memorial Hospital, Green Bay, Wisconsin, 54301, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, 54601, United States
Marshfield Clinic, Marshfield, Wisconsin, 54449-5772, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, 53226, United States
St. Vincent Hospital, Green Bay, Wisconsin, 54307-9070, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792-0001, United States
Australia, New South Wales
Children's Hospital at Westmead, Westmead, New South Wales, 2145, Australia
Sydney Children's Hospital, Randwick, New South Wales, 2031, Australia
Australia, Queensland
Royal Children's Hospital, Brisbane, Queensland, 4029, Australia
Australia, South Australia
Women's and Children's Hospital, North Adelaide, South Australia, 5006, Australia
Australia, Victoria
Royal Children's Hospital, Parkville, Victoria, 3052, Australia
Australia, Western Australia
Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia
Canada, Alberta
Alberta Children's Hospital, Calgary, Alberta, T2T 5C7, Canada
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Canada, British Columbia
British Columbia Children's Hospital, Vancouver, British Columbia, V6H 3V4, Canada
Canada, Manitoba
CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Canada, Nova Scotia
IWK Health Centre, Halifax, Nova Scotia, B3J 3G9, Canada
Canada, Ontario
Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada
Children's Hospital of Western Ontario, London, Ontario, N6C 2V5, Canada
Children's Hospital, Hamilton, Ontario, L8N 3Z5, Canada
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada
Canada, Quebec
Centre Hospitalier de L'Universite Laval, Sainte-Foy, Quebec, GIV 4G2, Canada
Hopital Sainte Justine, Montreal, Quebec, H3T 1C5, Canada
Laval University Medical Center, Sainte-Foy, Quebec, G1V 4G2, Canada
McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec, H3H 1P3, Canada
Canada, Saskatchewan
Allan Blair Cancer Centre, Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, S7N 4H4, Canada
Netherlands
Academisch Ziekenhuis Groningen, Groningen, 9700 RB, Netherlands
New Zealand
Starship Children's Hospital, Auckland, New Zealand
Puerto Rico
San Jorge Childrens Hospital, Santurce, 00912, Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, 00936-5067, Puerto Rico
Switzerland
Swiss Pediatric Oncology Group Bern, Bern, CH 3010, Switzerland
Swiss Pediatric Oncology Group Geneva, Geneva, CH 1211, Switzerland
Swiss Pediatric Oncology Group Lausanne, Lausanne, CH 1011, Switzerland
M. Fevzi Ozkaynak, MD, Study Chair, New York Medical College
More Information
Record last reviewed: April 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003739
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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