Vinorelbine in Treating Children With Recurrent or Refractory Cancers
25 de julio de 2014 actualizado por: Children's Oncology Group
A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children.
OUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australia, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Children's Hospital
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Alberta
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Calgary, Alberta, Canadá, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1A 1R8
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- Children's Hospital
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London, Ontario, Canadá, N6C 2V5
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canadá, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canadá, H3T 1C5
- Hopital Sainte Justine
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Montreal, Quebec, Canadá, H3H 1P3
- McGill University Health Center - Montreal Children's Hospital
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Sainte Foy, Quebec, Canadá, GIV 4G2
- Centre Hospitalier de l'Universite Laval
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Sainte-Foy, Quebec, Canadá, G1V 4G2
- Laval University Medical Center
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Estados Unidos, 36617-2293
- University of South Alabama Medical Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Phoenix Children's Hospital
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Tucson, Arizona, Estados Unidos, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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California
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Downey, California, Estados Unidos, 90242
- Southern California Permanente Medical Group
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Duarte, California, Estados Unidos, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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La Jolla, California, Estados Unidos, 92093-0658
- University of California San Diego Cancer Center
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Medical Center
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Long Beach, California, Estados Unidos, 90801-1428
- Jonathan Jaques Children'S Cancer Center
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Estados Unidos, 90027-0700
- Children's Hospital Los Angeles
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Madera, California, Estados Unidos, 93638
- Valley Children's Hospital
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Oakland, California, Estados Unidos, 94609
- Children's Hospital of Oakland
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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Children's Hospital at Stanford
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Sacramento, California, Estados Unidos, 95816
- Sutter Cancer Center
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Medical Center
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San Diego, California, Estados Unidos, 92120
- Kaiser Permanente-Southern California Permanente Medical Group
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San Diego, California, Estados Unidos, 92123-4282
- Children's Hospital and Health Center
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San Francisco, California, Estados Unidos, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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San Francisco, California, Estados Unidos, 94115
- Kaiser Permanente Medical Group - San Francisco
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Santa Barbara, California, Estados Unidos, 93102
- Santa Barbara Cottage Hospital
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Santa Clara, California, Estados Unidos, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Travis Air Force Base, California, Estados Unidos, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Childhood Hematology/Oncology Associates
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian-St Luke's Medical Center
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Denver, Colorado, Estados Unidos, 80218
- Children's Hospital of Denver
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06360-7106
- University of Connecticut Health Center
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Yale Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, Estados Unidos, 19899
- Alfred I. Dupont Institute
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Washington, District of Columbia, Estados Unidos, 20007
- Lombardi Cancer Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Broward General Medical Center
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Fort Myers, Florida, Estados Unidos, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Estados Unidos, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Hollywood, Florida, Estados Unidos, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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Miami, Florida, Estados Unidos, 33176-2197
- Baptist Hospital of Miami
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Miami, Florida, Estados Unidos, 33155
- Miami Children's Hospital
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Miami, Florida, Estados Unidos, 33136
- University of Miami-Jackson Memorial Hospital Medical Center
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Orlando, Florida, Estados Unidos, 32803
- Walt Disney Memorial Cancer Institute
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Orlando, Florida, Estados Unidos, 32806
- Nemours Children's Clinic-Orlando
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Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
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Tampa, Florida, Estados Unidos, 33677-4227
- Tampa Children's Hospital
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West Palm Beach, Florida, Estados Unidos, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Estados Unidos, 30342
- Children's Healthcare of Atlanta - Scottish Rite
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Augusta, Georgia, Estados Unidos, 30912-4000
- Medical College of Georgia Comprehensive Cancer Center
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Macon, Georgia, Estados Unidos, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Estados Unidos, 31403-3089
- Memorial Health University Medical Center, Inc.
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Estados Unidos, 96813
- Cancer Research Center of Hawaii
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Idaho
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Boise, Idaho, Estados Unidos, 83712
- Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital, Chicago
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Oak Lawn, Illinois, Estados Unidos, 60453
- Hope Children's Hospital
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Park Ridge, Illinois, Estados Unidos, 60068
- Lutheran General Hospital
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Peoria, Illinois, Estados Unidos, 61637
- Saint Jude Midwest Affiliate
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Rockford, Illinois, Estados Unidos, 61104
- University Child Health Services Clinic
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Springfield, Illinois, Estados Unidos, 62794-9230
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Hospital and Health Care Center
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Iowa
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Des Moines, Iowa, Estados Unidos, 50308
- Raymond Blank Memorial Hospital for Children
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Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Kansas
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Wichita, Kansas, Estados Unidos, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisville, Kentucky, Estados Unidos, 40232
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Estados Unidos, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Clinic
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Maine
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Bangor, Maine, Estados Unidos, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, Estados Unidos, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Estados Unidos, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Estados Unidos, 21225
- Sinai Hospital of Baltimore
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02111
- Boston Floating Hospital Infants and Children
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Medical Center
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Worcester, Massachusetts, Estados Unidos, 01655
- University of Massachusetts Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Mott Children's Hospital
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Detroit, Michigan, Estados Unidos, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Estados Unidos, 48236
- St. John Hospital and Medical Center
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East Lansing, Michigan, Estados Unidos, 48824
- Michigan State University
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Estados Unidos, 49503
- Spectrum Health and DeVos Children's Hospital
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Kalamazoo, Michigan, Estados Unidos, 49007
- Bronson Methodist Hospital
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Royal Oak, Michigan, Estados Unidos, 48073
- William Beaumont Hospital
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- Duluth Clinic
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Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics - Minneapolis
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Paul, Minnesota, Estados Unidos, 55102
- Children's Hospitals and Clinics of Minnesota
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Estados Unidos, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198-3330
- University of Nebraska Medical Center
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Omaha, Nebraska, Estados Unidos, 68114
- Children's Hospital of Omaha
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89109-2306
- Sunrise Hospital and Medical Center
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton Cancer Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, Estados Unidos, 08901
- Cancer Institute of New Jersey
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Newark, New Jersey, Estados Unidos, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Estados Unidos, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Estados Unidos, 07901
- Atlantic Health System
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
- University of New Mexico School of Medicine
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New York
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Albany, New York, Estados Unidos, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, Estados Unidos, 10467-2490
- Montefiore Medical Center
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Brooklyn, New York, Estados Unidos, 11219
- Maimonides Medical Center
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Brooklyn, New York, Estados Unidos, 11201
- Brooklyn Hospital Center
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Brooklyn, New York, Estados Unidos, 11203
- State University of New York Health Science Center at Brooklyn College of Medicine
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Brooklyn, New York, Estados Unidos, 11212
- Brookdale University Hospital and Medical Center
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, Estados Unidos, 11030
- North Shore University Hospital
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New Hyde Park, New York, Estados Unidos, 11042
- Schneider Children's Hospital
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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New York, New York, Estados Unidos, 10032
- Columbia Presbyterian Hospital
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Cancer Center
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Stony Brook, New York, Estados Unidos, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
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Syracuse, New York, Estados Unidos, 13210
- State University of New York - Upstate Medical University
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Valhalla, New York, Estados Unidos, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28801
- Mission Saint Joseph's Health System
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Charlotte, North Carolina, Estados Unidos, 28232-2861
- Carolinas Medical Center
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Charlotte, North Carolina, Estados Unidos, 28233-3549
- Presbyterian Healthcare
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Estados Unidos, 27858-4354
- East Carolina University School of Medicine
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58108-6001
- Dakota Cancer Institute
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Ohio
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Akron, Ohio, Estados Unidos, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Estados Unidos, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Estados Unidos, 43205-2696
- Children's Hospital of Columbus
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Dayton, Ohio, Estados Unidos, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, Estados Unidos, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Estados Unidos, 44501
- Forum Health-Tod Childrens Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Children's Hospital of Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center
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Oregon
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Portland, Oregon, Estados Unidos, 97201-3098
- Doernbecher Children's Hospital
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Portland, Oregon, Estados Unidos, 97227
- Legacy Emanuel Hospital and Health Center
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822-2001
- Geisinger Medical Center
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-0721
- Medical University of South Carolina
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Columbia, South Carolina, Estados Unidos, 29203
- Center for Cancer Treatment and Research
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Greenville, South Carolina, Estados Unidos, 29605
- Children's Hospital of Greenville Hospital System
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Estados Unidos, 57117
- Sioux Valley Hospital
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Tennessee
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Johnson City, Tennessee, Estados Unidos, 37614-0622
- James H. Quillen College of Medicine
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Knoxville, Tennessee, Estados Unidos, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Estados Unidos, 38105-2794
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, Estados Unidos, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, Estados Unidos, 78701
- Children's Hospital of Austin
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Dallas, Texas, Estados Unidos, 75230
- Medical City Dallas Hospital
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Dallas, Texas, Estados Unidos, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, Estados Unidos, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, Estados Unidos, 78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Lubbock, Texas, Estados Unidos, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Estados Unidos, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Estados Unidos, 78229
- Methodist Health Care System
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Temple, Texas, Estados Unidos, 76508
- Scott and White Memorial Hospital
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Vermont
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Burlington, Vermont, Estados Unidos, 05401-3498
- Vermont Cancer Center
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Cancer Center at the University of Virginia
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Falls Church, Virginia, Estados Unidos, 22042-3300
- Inova Fairfax Hospital
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Norfolk, Virginia, Estados Unidos, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Estados Unidos, 23708-2197
- Naval Medical Center, Portsmouth
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Richmond, Virginia, Estados Unidos, 23298-0037
- Massey Cancer Center
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Roanoke, Virginia, Estados Unidos, 24013
- Carilion Roanoke Community Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Seattle, Washington, Estados Unidos, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Estados Unidos, 98112
- Group Health Cooperative of Puget Sound
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Spokane, Washington, Estados Unidos, 99210-0248
- Deaconess Medical Center
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Tacoma, Washington, Estados Unidos, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Estados Unidos, 98405
- Mary Bridge Children's Health Center
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25302
- West Virginia University - Charleston
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Huntington, West Virginia, Estados Unidos, 25701
- Cabell-Huntington Hospital, Inc
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Morgantown, West Virginia, Estados Unidos, 26506-9300
- West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital
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Green Bay, Wisconsin, Estados Unidos, 54301
- Bellin Memorial Hospital
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Medical Center
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Madison, Wisconsin, Estados Unidos, 53792-0001
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center
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Auckland, Nueva Zelanda
- Starship Children's Hospital
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Groningen, Países Bajos, 9713 EZ
- Academisch Ziekenhuis Groningen
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
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Santurce, Puerto Rico, 00912
- San Jorge Childrens Hospital
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Bern, Suiza, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Suiza, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Suiza, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 21 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory solid malignant tumors of childhood including: Soft tissue sarcoma Rhabdomyosarcoma Nonrhabdomyosarcoma Extraosseous Ewing's sarcoma CNS tumors Astrocytoma Primitive neuroectodermal tumor Atypical teratoid/rhabdoid tumors Ependymoma Recurrent neuroblastoma Measurable disease No more than 2 prior treatment regimens
PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: For patients with solid tumors (unless marrow involvement): Absolute neutrophil count (ANC) at least 1000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) For patients post bone marrow transplantation: ANC at least 1,000/mm3 Platelet count at least 50,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) Hepatic: Total bilirubin no greater than 1.5 times normal SGOT/SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: Seizure disorder allowed if well controlled CNS toxicity no greater than grade 2
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior bone marrow transplantation No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for increased intracranial pressure due to CNS tumors Radiotherapy: At least 6 months since prior radiotherapy to craniospinal axis, spine, and/or more than 50% of the bony pelvis Concurrent radiotherapy to localized painful lesions allowed if at least one measurable lesion is not in radiation field Surgery: Not specified Other: No concurrent participation in another CCG, POG, or COG therapeutic study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Stratum 1 - Soft Tissue Sarcoma
See detailed description.
|
Otros nombres:
|
|
Experimental: Stratum 2 - CNS Tumors
See detailed description.
|
Otros nombres:
|
|
Experimental: Stratum 3 - Neuroblastoma
See detailed description.
|
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
|---|
|
Enfermedad progresiva
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: John F. Kuttesch, PhD, MD, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 1998
Finalización primaria (Actual)
1 de marzo de 2006
Finalización del estudio (Actual)
1 de marzo de 2007
Fechas de registro del estudio
Enviado por primera vez
1 de noviembre de 1999
Primero enviado que cumplió con los criterios de control de calidad
27 de octubre de 2003
Publicado por primera vez (Estimar)
28 de octubre de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de julio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
25 de julio de 2014
Última verificación
1 de julio de 2014
Más información
Términos relacionados con este estudio
Palabras clave
- Rabdomiosarcoma infantil recurrente
- neuroblastoma recurrente
- sarcoma de Ewing recurrente/tumor neuroectodérmico primitivo periférico
- Tumor neuroectodérmico primitivo supratentorial infantil recurrente
- astrocitoma cerebeloso infantil recurrente
- astrocitoma cerebral infantil recurrente
- ependimoma infantil recurrente
- sarcoma de tejido blando infantil recurrente
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores Neuroectodérmicos Primitivos
- Tumores Neuroectodérmicos Primitivos Periféricos
- Sarcoma
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Neuroblastoma
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Vinorelbina
Otros números de identificación del estudio
- A09705
- COG-A09705 (Otro identificador: Children's Oncology Group)
- CCG-09705 (Otro identificador: Children's Cancer Group)
- CDR0000066106 (Otro identificador: Clinical Trials.gov)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .