Neutropenia Clinical Trial
Official title:
Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
Verified date | February 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | September 2006 |
Est. primary completion date | December 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Australia | Royal Children's Hospital | Brisbane | Queensland |
Australia | Women's and Children's Hospital | North Adelaide | South Australia |
Australia | Royal Children's Hospital | Parkville | Victoria |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Australia | Sydney Children's Hospital | Randwick | New South Wales |
Australia | Children's Hospital at Westmead | Westmead | New South Wales |
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | Children's Hospital | Hamilton | Ontario |
Canada | Children's Hospital of Western Ontario | London | Ontario |
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Centre Hospitalier de L'Universite Laval | Sainte Foy | Quebec |
Canada | Laval University Medical Center | Sainte-Foy | Quebec |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Netherlands | Academisch Ziekenhuis Groningen | Groningen | |
New Zealand | Starship Children's Hospital | Auckland | |
Puerto Rico | University of Puerto Rico School of Medicine Medical Sciences Campus | San Juan | |
Puerto Rico | San Jorge Childrens Hospital | Santurce | |
Switzerland | Swiss Pediatric Oncology Group Bern | Bern | |
Switzerland | Swiss Pediatric Oncology Group Geneva | Geneva | |
Switzerland | Swiss Pediatric Oncology Group Lausanne | Lausanne | |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | Cancer Center of Albany Medical Center | Albany | New York |
United States | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico |
United States | Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas |
United States | Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Saint Joseph's Health System | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Scottish Rite | Atlanta | Georgia |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Medical College of Georgia Comprehensive Cancer Center | Augusta | Georgia |
United States | Children's Hospital of Austin | Austin | Texas |
United States | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Mountain States Tumor Institute | Boise | Idaho |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Floating Hospital for Children | Boston | Massachusetts |
United States | Albert Einstein Clinical Cancer Center | Bronx | New York |
United States | Brookdale University Hospital and Medical Center | Brooklyn | New York |
United States | Brooklyn Hospital Center | Brooklyn | New York |
United States | Maimonides Medical Center | Brooklyn | New York |
United States | State University of New York Health Science Center at Brooklyn College of Medicine | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University - Charleston | Charleston | West Virginia |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Presbyterian Healthcare | Charlotte | North Carolina |
United States | Cancer Center at the University of Virginia | Charlottesville | Virginia |
United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
United States | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | Children's Hospital Medical Center - Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Palmetto Health South Carolina Cancer Center | Columbia | South Carolina |
United States | Children's Hospital of Columbus | Columbus | Ohio |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | Simmons Cancer Center - Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Children's Medical Center - Dayton | Dayton | Ohio |
United States | Childhood Hematology/Oncology Associates | Denver | Colorado |
United States | Children's Hospital of Denver | Denver | Colorado |
United States | Presbyterian-St Luke's Medical Center | Denver | Colorado |
United States | John Stoddard Cancer Center | Des Moines | Iowa |
United States | Raymond Blank Memorial Hospital for Children | Des Moines | Iowa |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | St. John Hospital and Medical Center | Detroit | Michigan |
United States | Southern California Permanente Medical Group | Downey | California |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | St. Mary's/Duluth Clinic Cancer Center | Duluth | Minnesota |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Michigan State University | East Lansing | Michigan |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Dakota Cancer Institute | Fargo | North Dakota |
United States | University of Connecticut Health Center | Farmington | Connecticut |
United States | Hurley Medical Center | Flint | Michigan |
United States | Broward General Medical Center | Fort Lauderdale | Florida |
United States | Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
United States | Shands Hospital and Clinics, University of Florida | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | Spectrum Health and DeVos Children's Hospital | Grand Rapids | Michigan |
United States | Bellin Memorial Hospital | Green Bay | Wisconsin |
United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Children's Hospital of Greenville Hospital System | Greenville | South Carolina |
United States | East Carolina University School of Medicine | Greenville | North Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Joe DiMaggio Children's Hospital at Memorial | Hollywood | Florida |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Cabell-Huntington Hospital, Inc | Huntington | West Virginia |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | St. Vincent Hospital and Health Care Center | Indianapolis | Indiana |
United States | Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | East Tennessee State University Cancer Center at JCMC | Johnson City | Tennessee |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | East Tennessee Children's Hospital | Knoxville | Tennessee |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base | Texas |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Jonathan Jaques Children's Cancer Center | Long Beach | California |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | Covenant Children's Hospital | Lubbock | Texas |
United States | Medical Center of Central Georgia | Macon | Georgia |
United States | Children's Hospital Central California | Madera | California |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | North Shore University Hospital | Manhasset | New York |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Baptist Hospital of Miami | Miami | Florida |
United States | Miami Children's Hospital | Miami | Florida |
United States | University of Miami-Jackson Memorial Hospital | Miami | Florida |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | Children's Hospitals and Clinics - Minneapolis | Minneapolis | Minnesota |
United States | University of South Alabama Medical Center | Mobile | Alabama |
United States | West Virginia University Hospitals | Morgantown | West Virginia |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Yale Comprehensive Cancer Center | New Haven | Connecticut |
United States | Schneider Children's Hospital | New Hyde Park | New York |
United States | Children's Hospital of New Orleans | New Orleans | Louisiana |
United States | Ochsner Clinic | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Columbia Presbyterian Hospital | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | New York Presbyterian Hospital - Cornell Campus | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Children's Hospital of the King's Daughters | Norfolk | Virginia |
United States | Hope Children's Hospital | Oak Lawn | Illinois |
United States | Children's Hospital of Oakland | Oakland | California |
United States | Children's Hospital of Oklahoma | Oklahoma City | Oklahoma |
United States | Children's Hospital of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Chao Family Comprehensive Cancer Center | Orange | California |
United States | Children's Hospital of Orange County | Orange | California |
United States | Florida Hospital Cancer Institute | Orlando | Florida |
United States | Nemours Children's Clinic-Orlando | Orlando | Florida |
United States | Lucile Packard Children's Hospital at Stanford | Palo Alto | California |
United States | Lutheran General Hospital | Park Ridge | Illinois |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | Sacred Heart Children's Hospital | Pensacola | Florida |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Doernbecher Children's Hospital | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center | Portland | Oregon |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Massey Cancer Center | Richmond | Virginia |
United States | Carilion Medical Center for Children | Roanoke | Virginia |
United States | James P. Wilmot Cancer Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Sutter Cancer Center | Sacramento | California |
United States | University of California Davis Medical Center | Sacramento | California |
United States | Cardinal Glennon Children's Hospital | Saint Louis | Missouri |
United States | St. Louis Children's Hospital | Saint Louis | Missouri |
United States | Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Methodist Health Care System | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Children's Hospital San Diego | San Diego | California |
United States | Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego | California |
United States | Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco | California |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
United States | Santa Barbara Cottage Hospital | Santa Barbara | California |
United States | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California |
United States | Memorial Health University Medical Center, Inc. | Savannah | Georgia |
United States | Maine Children's Cancer Program | Scarborough | Maine |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Cooperative | Seattle | Washington |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Sioux Valley Hospital | Sioux Falls | South Dakota |
United States | Deaconess Medical Center | Spokane | Washington |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | All Children's Hospital | St. Petersburg | Florida |
United States | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York |
United States | Atlantic Health System | Summit | New Jersey |
United States | State University of New York - Upstate Medical University | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Mary Bridge Children's Health Center | Tacoma | Washington |
United States | Tampa Children's Hospital | Tampa | Florida |
United States | Scott and White Memorial Hospital | Temple | Texas |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Children's Hospital | Toledo | Ohio |
United States | David Grant Medical Center | Travis Air Force Base | California |
United States | Arizona Cancer Center | Tucson | Arizona |
United States | CCOP - Oklahoma | Tulsa | Oklahoma |
United States | Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Lombardi Cancer Center | Washington | District of Columbia |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | St. Mary's Hospital | West Palm Beach | Florida |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Alfred I. Dupont Institute | Wilmington | Delaware |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center - University Campus | Worcester | Massachusetts |
United States | Forum Health-Tod Childrens Hospital | Youngstown | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland,
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] 200
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 Can — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Secondary | 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. | No |
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