Temozolomide Plus Lomustine etterfulgt av strålebehandling ved behandling av pasienter med høygradig ondartet gliom
11. februar 2014 oppdatert av: Children's Oncology Group
En fase I-studie av temozolomid og CCNU hos pediatriske pasienter med nylig diagnostisert ufullstendig resekert høygradige gliomer uten hjernestamme
BAKGRUNN: Legemidler som brukes i kjemoterapi bruker forskjellige måter å stoppe tumorceller i å dele seg slik at de slutter å vokse eller dør. Strålebehandling bruker høyenergi røntgenstråler for å skade tumorceller. Å kombinere mer enn ett kjemoterapimedikament med strålebehandling kan drepe flere tumorceller.
FORMÅL: Fase I-studie for å studere effektiviteten av temozolomid pluss lomustin etterfulgt av strålebehandling ved behandling av pasienter som har malignt gliom av høy grad.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
MÅL:
- Bestem den maksimalt tolererte dosen av temozolomid når det administreres sammen med lomustin hos pasienter med høygradige maligne gliomer.
- Bestem de dosebegrensende toksiske effektene av dette regimet hos disse pasientene.
- Evaluer muligheten for strålebehandling etter dette behandlingsregimet i denne pasientpopulasjonen.
- Evaluer de radiografiske responsene hos pasienter behandlet med dette regimet.
OVERSIKT: Dette er en multisenter, dose-eskaleringsstudie av temozolomid.
Pasienter får oral temozolomid på dag 1-5 og oral lomustin på dag 1. Behandlingen fortsetter hver 28. dag, hvis blodtellingen har kommet seg, i 2 kurer i fravær av sykdomsprogresjon eller uakseptabel toksisitet. Pasientene gjennomgår deretter strålebehandling på dag 1-5 ukentlig i 6 uker. Pasientene fortsetter det samme kjemoterapiregimet i opptil 6 kurer til, som begynner 4 uker etter fullført strålebehandling.
Kohorter på 3-6 pasienter får eskalerende doser av temozolomid inntil maksimal tolerert dose (MTD) er bestemt. MTD er definert som dosen forut for den der 2 av 3 eller 2 av 6 pasienter opplever dosebegrensende toksisitet.
Pasientene følges for overlevelse.
PROSJEKTERT PENGING: Totalt 3-30 pasienter vil bli påløpt til denne studien.
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and 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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-
-
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Alberta
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Calgary, Alberta, Canada, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Children's Hospital
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London, Ontario, Canada, N6C 2V5
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Montreal, Quebec, Canada, H3H 1P3
- McGill University Health Center - Montreal Children's Hospital
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Sainte Foy, Quebec, Canada, GIV 4G2
- Centre Hospitalier de l'Université Laval
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Sainte-Foy, Quebec, Canada, G1V 4G2
- Laval University Medical Center
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Forente stater, 36604
- University of South Alabama Medical Center
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Arizona
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Phoenix, Arizona, Forente stater, 85016-7710
- Phoenix Children's Hospital
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Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- University of Arkansas for Medical Sciences
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California
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Downey, California, Forente stater, 90242
- Southern California Permanente Medical Group
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Duarte, California, Forente stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Forente stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, Forente stater, 92354
- Loma Linda University Medical Center
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Long Beach, California, Forente stater, 90801-1428
- Jonathan Jaques Children'S Cancer Center
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Los Angeles, California, Forente stater, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forente stater, 90027-0700
- Children's Hospital Los Angeles
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Madera, California, Forente stater, 93638-8762
- Children's Hospital Central California
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Oakland, California, Forente stater, 94609-1809
- Children's Hospital of Oakland
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Orange, California, Forente stater, 92868
- Chao Family Comprehensive Cancer Center
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Orange, California, Forente stater, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford
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Sacramento, California, Forente stater, 95816
- Sutter Cancer Center
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Sacramento, California, Forente stater, 95817
- University of California Davis Medical Center
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San Diego, California, Forente stater, 92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
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San Diego, California, Forente stater, 92123-4282
- Children's Hospital San Diego
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San Francisco, California, Forente stater, 94115
- Kaiser Permanente Medical Center - San Francisco Geary Campus
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San Francisco, California, Forente stater, 94143-0128
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, Forente stater, 93102
- Santa Barbara Cottage Hospital
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Santa Clara, California, Forente stater, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
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Travis Air Force Base, California, Forente stater, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Forente stater, 80218-1088
- Children's Hospital of Denver
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Denver, Colorado, Forente stater, 80218
- Childhood Hematology/Oncology Associates
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Denver, Colorado, Forente stater, 80218
- Presbyterian-St Luke's Medical Center
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Connecticut
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Farmington, Connecticut, Forente stater, 06360-7106
- University of Connecticut Health Center
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New Haven, Connecticut, Forente stater, 06520-8028
- Yale Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, Forente stater, 19899
- Alfred I. Dupont Institute
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District of Columbia
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Washington, District of Columbia, Forente stater, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical Center
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Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer Center
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Florida
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Fort Lauderdale, Florida, Forente stater, 33316
- Broward General Medical Center
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Fort Myers, Florida, Forente stater, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Forente stater, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Hollywood, Florida, Forente stater, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Forente stater, 32207
- Nemours Children's Clinic
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Miami, Florida, Forente stater, 33176-2197
- Baptist Hospital of Miami
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Miami, Florida, Forente stater, 33136
- University of Miami-Jackson Memorial Hospital
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Miami, Florida, Forente stater, 33155-4069
- Miami Children's Hospital
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Orlando, Florida, Forente stater, 32803
- Florida Hospital Cancer Institute
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Orlando, Florida, Forente stater, 32806
- Nemours Children's Clinic-Orlando
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Pensacola, Florida, Forente stater, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Forente stater, 33701
- All Children's Hospital
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Tampa, Florida, Forente stater, 33677-4227
- Tampa Children's Hospital
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West Palm Beach, Florida, Forente stater, 33407
- St. Mary's Hospital
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital - Atlanta
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Atlanta, Georgia, Forente stater, 30342
- Children's Healthcare of Atlanta - Scottish Rite
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Augusta, Georgia, Forente stater, 30912-4000
- Medical College of Georgia Comprehensive Cancer Center
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Macon, Georgia, Forente stater, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Forente stater, 31403-3089
- Memorial Health University Medical Center, Inc.
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Hawaii
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Honolulu, Hawaii, Forente stater, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Forente stater, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Forente stater, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Forente stater, 83712
- Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Forente stater, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, Forente stater, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Forente stater, 60601
- University of Chicago Cancer Research Center
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Oak Lawn, Illinois, Forente stater, 60453
- Hope Children's Hospital
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Park Ridge, Illinois, Forente stater, 60068-1174
- Lutheran General Hospital
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Peoria, Illinois, Forente stater, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Forente stater, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Forente stater, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, Forente stater, 46260
- St. Vincent Hospital and Health Care Center
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Iowa
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Des Moines, Iowa, Forente stater, 50308
- Raymond Blank Memorial Hospital for Children
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Des Moines, Iowa, Forente stater, 50309
- John Stoddard Cancer Center
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Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center
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Kansas
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Wichita, Kansas, Forente stater, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Forente stater, 40536-0284
- Albert B. Chandler Medical Center, University of Kentucky
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Louisville, Kentucky, Forente stater, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forente stater, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Clinic
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Maine
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Bangor, Maine, Forente stater, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, Forente stater, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Forente stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forente stater, 21201-1595
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, Forente stater, 21225
- Sinai Hospital of Baltimore
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Forente stater, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Forente stater, 01107
- Baystate Medical Center
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109-0914
- Mott Children's Hospital
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Forente stater, 48236
- St. John Hospital and Medical Center
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East Lansing, Michigan, Forente stater, 48824
- Michigan State University
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Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forente stater, 49503
- Spectrum Health and DeVos Children's Hospital
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Kalamazoo, Michigan, Forente stater, 49007
- Bronson Methodist Hospital
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Royal Oak, Michigan, Forente stater, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Forente stater, 48073-6769
- William Beaumont Hospital
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Minnesota
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Duluth, Minnesota, Forente stater, 55805-1983
- St. Mary's/Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Forente stater, 55404
- Children's Hospitals and Clinics - Minneapolis
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Saint Paul, Minnesota, Forente stater, 55102
- Children's Hospitals and Clinics of Minnesota
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Mississippi
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Jackson, Mississippi, Forente stater, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Forente stater, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Forente stater, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Forente stater, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, Forente stater, 68198-2168
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89109-2306
- Sunrise Hospital and Medical Center
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, Forente stater, 08903
- Cancer Institute Of New Jersey
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Newark, New Jersey, Forente stater, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forente stater, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Forente stater, 07901
- Atlantic Health System
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, Forente stater, 12208
- Cancer Center of Albany Medical Center
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Bronx, New York, Forente stater, 10461
- Albert Einstein Clinical Cancer Center
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Brooklyn, New York, Forente stater, 11219
- Maimonides Medical Center
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Brooklyn, New York, Forente stater, 11201
- Brooklyn Hospital Center
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Brooklyn, New York, Forente stater, 11203
- State University of New York Health Science Center at Brooklyn College of Medicine
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Brooklyn, New York, Forente stater, 11212
- Brookdale University Hospital and Medical Center
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
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New Hyde Park, New York, Forente stater, 11042
- Schneider Children's Hospital
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forente stater, 10029
- Mount Sinai School of Medicine
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New York, New York, Forente stater, 10021-4885
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Forente stater, 10032
- Columbia Presbyterian Hospital
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Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center
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Stony Brook, New York, Forente stater, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
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Syracuse, New York, Forente stater, 13210
- State University of New York - Upstate Medical University
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Valhalla, New York, Forente stater, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Forente stater, 28801
- Mission Saint Joseph's Health System
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Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Charlotte, North Carolina, Forente stater, 28232-2861
- Carolinas Medical Center
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Charlotte, North Carolina, Forente stater, 28233-3549
- Presbyterian Healthcare
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Forente stater, 27858-4354
- East Carolina University School of Medicine
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Winston-Salem, North Carolina, Forente stater, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
-
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North Dakota
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Fargo, North Dakota, Forente stater, 58103-4940
- Dakota Cancer Institute
-
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Ohio
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Akron, Ohio, Forente stater, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Forente stater, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forente stater, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Forente stater, 43205-2696
- Children's Hospital of Columbus
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Dayton, Ohio, Forente stater, 45404
- Children's Medical Center - Dayton
-
Toledo, Ohio, Forente stater, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Forente stater, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Forente stater, 44501
- Forum Health-Tod Childrens Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Children's Hospital of Oklahoma
-
Tulsa, Oklahoma, Forente stater, 74136
- Natalie Warren Bryant Cancer Center
-
Tulsa, Oklahoma, Forente stater, 74136
- CCOP - Oklahoma
-
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Oregon
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Portland, Oregon, Forente stater, 97201-3098
- Doernbecher Children's Hospital
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Portland, Oregon, Forente stater, 97227
- Legacy Emanuel Hospital and Health Center
-
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, Forente stater, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Forente stater, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Children's Hospital of Pittsburgh
-
-
Rhode Island
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Providence, Rhode Island, Forente stater, 02818
- Rhode Island Hospital
-
-
South Carolina
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Charleston, South Carolina, Forente stater, 29425-0721
- Medical University of South Carolina
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Columbia, South Carolina, Forente stater, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Forente stater, 29605
- Children's Hospital of Greenville Hospital System
-
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57105-1080
- Avera Cancer Institute
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Sioux Falls, South Dakota, Forente stater, 57117
- Sioux Valley Hospital
-
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Tennessee
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Johnson City, Tennessee, Forente stater, 37604
- East Tennessee State University Cancer Center at JCMC
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Knoxville, Tennessee, Forente stater, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Forente stater, 38105-2794
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, Forente stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
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Texas
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Amarillo, Texas, Forente stater, 79106
- Texas Tech University Health Sciences Center School of Medicine
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Austin, Texas, Forente stater, 78701
- Children's Hospital of Austin
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Dallas, Texas, Forente stater, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, Forente stater, 75235-9154
- Simmons Cancer Center - Dallas
-
Fort Worth, Texas, Forente stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Galveston, Texas, Forente stater, 77555-0361
- University of Texas Medical Branch
-
Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
-
Houston, Texas, Forente stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Lackland Air Force Base, Texas, Forente stater, 78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
-
Lubbock, Texas, Forente stater, 79410
- Covenant Children's Hospital
-
San Antonio, Texas, Forente stater, 78207
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Forente stater, 78229-3902
- Methodist Health Care System
-
Temple, Texas, Forente stater, 76508
- Scott and White Memorial Hospital
-
-
Utah
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Salt Lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute
-
-
Vermont
-
Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908
- Cancer Center at the University of Virginia
-
Falls Church, Virginia, Forente stater, 22042-3300
- INOVA Fairfax Hospital
-
Norfolk, Virginia, Forente stater, 23507
- Children's Hospital of The King's Daughters
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Portsmouth, Virginia, Forente stater, 23708-5100
- Naval Medical Center, Portsmouth
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Richmond, Virginia, Forente stater, 23298-0037
- Massey Cancer Center
-
Roanoke, Virginia, Forente stater, 24013
- Carilion Medical Center for Children
-
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Washington
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Seattle, Washington, Forente stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forente stater, 98112
- Group Health Cooperative
-
Spokane, Washington, Forente stater, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Forente stater, 98431-5000
- Madigan Army Medical Center
-
Tacoma, Washington, Forente stater, 98415-0299
- Mary Bridge Children's Health Center
-
-
West Virginia
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Charleston, West Virginia, Forente stater, 25302
- West Virginia University - Charleston
-
Huntington, West Virginia, Forente stater, 25701
- Cabell-Huntington Hospital, Inc
-
Morgantown, West Virginia, Forente stater, 26506-9300
- West Virginia University Hospitals
-
-
Wisconsin
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Green Bay, Wisconsin, Forente stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forente stater, 54301
- Bellin Memorial Hospital
-
Green Bay, Wisconsin, Forente stater, 54307-9070
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Forente stater, 53792-0001
- University of Wisconsin Hospital and Clinics
-
Marshfield, Wisconsin, Forente stater, 54449-5772
- Marshfield Clinic
-
Milwaukee, Wisconsin, Forente stater, 53226
- Midwest Children's Cancer Center
-
-
-
-
-
Groningen, Nederland, 9700 RB
- Academisch Ziekenhuis Groningen
-
-
-
-
-
Auckland, New Zealand
- Starship Children's Hospital
-
-
-
-
-
San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
-
Santurce, Puerto Rico, 00912
- San Jorge Childrens Hospital
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Bern, Sveits, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Sveits, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Sveits, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
3 år til 21 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
SYKDOMENS KARAKTERISTIKA:
Histologisk bekreftet høygradig malignt gliom av en av følgende undertyper:
- Glioblastom
- Anaplastisk astrocytom
- Anaplastisk oligoastrocytom
- Gliomatosis cerebri
- Ingen disseminert sykdom eller primære ryggmargsmaligniteter
- Målbar intrakraniell restsykdom ved MR
PASIENT EGENSKAPER:
Alder:
- 3 og over
- Under 22 ved diagnosetidspunktet
Ytelsesstatus:
- Karnofsky 50-100 % hvis over 10 år
- Lansky 50-100 % hvis 10 år eller yngre
Forventet levealder:
- Minst 8 uker
Hematopoetisk:
- Absolutt nøytrofiltall minst 1000/mm^3
- Blodplateantall minst 100 000/mm^3 (transfusjonsuavhengig)
- Hemoglobin minst 8,0 g/dL (RBC-transfusjoner tillatt)
Hepatisk:
- Bilirubin ikke mer enn 1,5 ganger normalt for alder
- SGPT ikke mer enn 2,5 ganger normal for alder
- Albumin minst 2 g/dL
Nyre:
- Kreatinin ikke mer enn 1,5 ganger normalt for alder ELLER
- Kreatininclearance eller radioisotop glomerulær filtrasjonshastighet minst nedre normalgrense for alder
Lunge:
- Ingen dyspné i hvile
- Ingen treningsintoleranse
- Pulsoksymetri minst 94 %
Annen:
- Ikke gravid eller ammende
- Negativ graviditetstest
- Fertile pasienter må bruke effektiv prevensjon
- Ingen ukontrollert infeksjon
FØR SAMTIDIG TERAPI:
Biologisk terapi:
- Ingen tidligere biologisk behandling
- Ingen samtidige profylaktiske hematopoetiske vekstfaktorer
Kjemoterapi:
- Ingen tidligere kjemoterapi
Endokrin terapi:
- Tidligere kortikosteroidbehandling tillatt
- Ingen samtidige kortikosteroider som antiemetika
Strålebehandling:
- Ingen tidligere strålebehandling
Kirurgi:
- Ikke mer enn 31 dager siden forrige maksimale nevrokirurgiske prosedyre
Annen:
- Ingen samtidig fenobarbital eller cimetidin
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Kjemoterapi før og etter strålebehandling
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Progresjonsfri overlevelse
Tidsramme: Lengde på studiet
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Denne studien er en fase I-evaluering av temozolomid i kombinasjon med en fast dose CCNU med startdosen for temozolomid
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Lengde på studiet
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Regina Jakacki, MD, University of Pittsburgh
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2000
Primær fullføring (Faktiske)
1. januar 2005
Studiet fullført (Faktiske)
1. september 2006
Datoer for studieregistrering
Først innsendt
5. juli 2000
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. februar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ADVL0011
- COG-ADVL0011 (Annen identifikator: Children's Oncology Group)
- CCG-ADVL0011 (Annen identifikator: Children's Cancer Group)
- CCG-A0993 (Annen identifikator: Children's Cancer Group)
- CDR0000068036 (Annen identifikator: Clinical Trials.gov)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .