Kjemoterapi og strålebehandling etter kirurgi ved behandling av barn med nylig diagnostisert astrocytom, glioblastoma multiforme, gliosarkom eller diffust indre pontinsk gliom
19. februar 2014 oppdatert av: Children's Oncology Group
En fase II-studie av temozolomid i behandling av barn med høygradig gliom
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 gi kjemoterapi sammen med strålebehandling kan drepe flere tumorceller.
FORMÅL: Denne fase II-studien studerer hvor godt det å gi kjemoterapi sammen med strålebehandling etter operasjon etterfulgt av kjemoterapi alene fungerer hos barn med nydiagnostisert astrocytom, glioblastoma multiforme, gliosarcoma eller diffust intrinsic pontine glioma.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
MÅL:
- Sammenlign den hendelsesfrie overlevelsen til pasienter med nylig diagnostisert anaplastisk astrocytom, glioblastoma multiforme, gliosarkom eller diffust intrinsic pontine glioma (DIPG) behandlet med adjuvant temozolomid administrert samtidig med postoperativ strålebehandling og deretter alene som vedlikeholdsbehandling i tidligere behandling kontra historisk behandling. Studier av Onkologigruppe og Barnekreftgruppe.
- Bestem toksisiteten til dette regimet hos disse pasientene.
- Bestem effekten av dette regimet hos pasienter med DIPG.
- Bestem toksisiteten til dette regimet hos pasienter med DIPG.
OVERSIKT: Dette er en multisenterstudie.
- Adjuvant kjemoradioterapi: Fra og med 6 uker etter kirurgisk reseksjon eller diagnose*, gjennomgår pasienter uten grov restsykdom kraniebestråling 5 dager i uken i 6 uker. Fra og med 6 uker etter kirurgisk reseksjon gjennomgår pasienter med grov gjenværende sykdom strålebehandling som ovenfor etterfulgt av booststrålebehandling i 1 uke. Alle pasienter får oralt temozolomid én gang daglig, som begynner innen 5 dager etter oppstart av strålebehandling og fortsetter i totalt 6 uker i fravær av sykdomsprogresjon eller uakseptabel toksisitet.
- Adjuvant vedlikeholdsbehandling: Fra og med 4 uker etter fullført adjuvant kjemoradioterapi får pasientene oral temozolomid på dag 1-5. Behandlingen gjentas hver 28. dag i totalt 10 kurer i fravær av sykdomsprogresjon eller uakseptabel toksisitet.
MERK: *Kun for pasienter med diffust intrinsisk pontingliom
Pasientene følges hver 3.-6. måned i 4 år og deretter årlig.
PROSJEKTERT PASSING: Totalt 50-60 pasienter vil bli påløpt for denne studien innen 12-14 måneder.
Studietype
Intervensjonell
Registrering (Faktiske)
170
Fase
- Fase 2
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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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 at University of Alberta
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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, L8S 4J9
- McMaster Children's Hospital at Hamilton Health Sciences
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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, H3G 1A4
- Montreal Children's Hospital at McGill University Health Center
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Sainte Foy, Quebec, Canada, GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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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
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Mobile, Alabama, Forente stater, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, Forente stater, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Arkansas Cancer Research Center at 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 Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Forente stater, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Forente stater, 90027-0700
- Children's Hospital Los Angeles
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Los Angeles, California, Forente stater, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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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 and Research Center at Oakland
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Orange, California, Forente stater, 92868
- Children's Hospital of Orange County
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Orange, California, Forente stater, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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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 Cancer Center
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Sacramento, California, Forente stater, 95825
- Kaiser Permanente Medical Center - Sacramento
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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 and Health Center - San Diego
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San Francisco, California, Forente stater, 94143
- 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 Kiely Campus
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Travis Air Force Base, California, Forente stater, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
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Colorado
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Denver, Colorado, Forente stater, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Forente stater, 80218
- Children's Hospital Cancer Center
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Connecticut
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Farmington, Connecticut, Forente stater, 06360-7106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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New Haven, Connecticut, Forente stater, 06520-8064
- Yale Comprehensive Cancer Center
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Delaware
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Wilmington, Delaware, Forente stater, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical 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, 32610-0296
- University of Florida Shands Cancer Center
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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, 33155
- Miami Children's Hospital
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Miami, Florida, Forente stater, 33136
- Jackson Memorial Hospital
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Miami, Florida, Forente stater, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Forente stater, 32804
- 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
- St. Joseph's Children's Hospital of Tampa
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West Palm Beach, Florida, Forente stater, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Forente stater, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Forente stater, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Forente stater, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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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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Idaho
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Boise, Idaho, Forente stater, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University 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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Chicago, Illinois, Forente stater, 60612
- University of Illinois Medical Center
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Oak Lawn, Illinois, Forente stater, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Forente stater, 60068-1174
- Lutheran General Cancer Care Center
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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, 46202-5225
- Riley Children Cancer Center at Riley Hospital for Children
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Indianapolis, Indiana, Forente stater, 46260
- St. Vincent Hospitals and Health Care Centers
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Iowa
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Des Moines, Iowa, Forente stater, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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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
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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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, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Forente stater, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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New Orleans, Louisiana, Forente stater, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Forente stater, 04401
- Pediatric Specialty Clinic at Eastern Maine Medical Center
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Scarborough, Maine, Forente stater, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Forente stater, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, Forente stater, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Forente stater, 21231-7223
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Silver Spring, Maryland, Forente stater, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber/Harvard Cancer Center at 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 Regional Cancer Program at D'Amour Center for Cancer Care
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Worcester, Massachusetts, Forente stater, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Forente stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forente stater, 49503
- DeVos Children's Hospital
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Kalamazoo, Michigan, Forente stater, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Forente stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Forente stater, 48073-6769
- William Beaumont Hospital - Royal Oak Campus
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Minnesota
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Duluth, Minnesota, Forente stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Forente stater, 55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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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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Columbia, Missouri, Forente stater, 65203
- University of Missouri - Columbia
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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
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89109
- Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical 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 at UMDNJ - Robert Wood Johnson Medical School
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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
- Valerie Fund Children's Center at Atlantic Health
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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
- Children's Hospital at Albany Medical Center
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Bronx, New York, Forente stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Forente stater, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Forente stater, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, Forente stater, 11201-5493
- Brooklyn Hospital Center
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Brooklyn, New York, Forente stater, 11219
- Comprehensive Cancer Center at Maimonides Medical Center
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New Hyde Park, New York, Forente stater, 11040
- 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, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center
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Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Forente stater, 11794-8174
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical University Hospital
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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 Hospitals - Memorial Campus
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Chapel Hill, North Carolina, Forente stater, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Forente stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Forente stater, 28233
- Presbyterian Cancer Center at Presbyterian Hospital
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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
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
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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 at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, Forente stater, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Forente stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, Forente stater, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Forente stater, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, Forente stater, 45404
- Children's Medical Center - Dayton
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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
- Tod Children's Hospital - Forum Health
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Children's Hospital at Oklahoma University Medical Center
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Tulsa, Oklahoma, Forente stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Portland, Oregon, Forente stater, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Forente stater, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, Forente stater, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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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
- Penn State Children's Hospital
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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
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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hospital
-
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South Carolina
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Charleston, South Carolina, Forente stater, 29425-0721
- Hollings Cancer Center at 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, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, Forente stater, 57105-1080
- Avera Cancer Institute
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Tennessee
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Johnson City, Tennessee, Forente stater, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, Forente stater, 37901
- East Tennessee Children's Hospital
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Memphis, Tennessee, Forente stater, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Forente stater, 37232-6310
- Vanderbilt Children's Hospital
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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
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Dallas, Texas, Forente stater, 75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
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Fort Worth, Texas, Forente stater, 76104
- Cook Children's Medical Center - Fort Worth
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Galveston, Texas, Forente stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
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Houston, Texas, Forente stater, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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Lackland Air Force Base, Texas, Forente stater, 78236
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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Lubbock, Texas, Forente stater, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Forente stater, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Forente stater, 78229-3900
- MBCCOP - South Texas Pediatrics
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San Antonio, Texas, Forente stater, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, Forente stater, 76508
- CCOP - Scott and White Hospital
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Temple, Texas, Forente stater, 76508
- Center for Cancer Prevention and Care at Scott and White Clinic
-
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute at University of Utah
-
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Vermont
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Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center at University of Vermont
-
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, Forente stater, 22042-3300
- INOVA Fairfax Hospital
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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, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
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Roanoke, Virginia, Forente stater, 24029
- Carilion Medical Center for Children at Roanoke Community Hospital
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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 Central Hospital
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Spokane, Washington, Forente stater, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Forente stater, 98415-0299
- Mary Bridge Children's Hospital and Health Center - Tacoma
-
Tacoma, Washington, Forente stater, 98431-0001
- Madigan Army Medical Center
-
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West Virginia
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Charleston, West Virginia, Forente stater, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington, West Virginia, Forente stater, 25701
- Cabell Huntington Hospital
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Morgantown, West Virginia, Forente stater, 26506-9300
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Green Bay, Wisconsin, Forente stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Green Bay, Wisconsin, Forente stater, 54301
- Bellin Memorial Hospital
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Green Bay, Wisconsin, Forente stater, 54307-9070
- St. Vincent Hospital
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La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Forente stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Forente stater, 54449
- CCOP - Marshfield Clinic Research Foundation
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Marshfield, Wisconsin, Forente stater, 54449-5772
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Forente stater, 53226
- Midwest Children's Cancer Center
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-
-
-
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Groningen, Nederland, 9700 RB
- University Medical Center Groningen
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-
-
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Auckland, New Zealand
- Starship Children's Health
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-
-
-
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San Juan, Puerto Rico, 00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
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Santurce, Puerto Rico, 00912
- San Jorge Children's Hospital
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-
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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 nylig diagnostisert CNS-svulst av følgende typer:
Høygradig gliom (HGG) av en av følgende histologier:
- Anaplastisk astrocytom (grad III)
- Glioblastoma multiforme (grad IV)
- Gliosarkom
- Primært malignt gliom i ryggmargen
Diffuse intrinsic pontine glioma (DIPG)
- Diagnostisert ved gadolinium-forsterket MR
- Minst 2/3 av svulsten lokalisert i pons OG svulst oppsto tydelig i pons
- Ingen diffus leptomeningeal sykdom
Ingen svulster med trekk som ikke er typiske for diffust indre hjernestammegliom, inkludert noen av følgende:
- Dorsalt eksofytisk hjernestammegliom
- Cervico-medullær junction tumor
- Fokal lavgradig gliom i mellomhjernen eller hjernestammen
- Ingen diffus hjernestammeforstørrelse på grunn av nevrofibromatose
- Ingen primær hjernestamme malignt gliom
- Ingen M+ sykdom (CSF positiv for tumor eller metastatisk sykdom)
- Må begynne å studere strålebehandling innen 6 uker etter kirurgisk reseksjon (for HGG-pasienter) eller diagnose (for DIPG-pasienter)
PASIENT EGENSKAPER:
Alder:
- 3 til 21
Ytelsesstatus:
- Karnofsky 50-100 % ELLER
- Lansky 50-100 %
Forventet levealder:
- Minst 2 måneder
Hematopoetisk:
- Absolutt nøytrofiltall minst 1000/mm^3
- Blodplateantall minst 100 000/mm^3*
- Hemoglobin minst 10,0 g/dL* MERK: *Transfusjonsuavhengig
Hepatisk:
- Bilirubin ikke høyere enn 1,5 ganger øvre normalgrense (ULN)
- SGOT eller SGPT mindre enn 2,5 ganger ULN
Nyre:
- Kreatinin ikke høyere enn 1,5 ganger ULN
Annen:
- Ingen annen samtidig malignitet
- Samtidig anfallsforstyrrelse tillatt hvis godt kontrollert med antikonvulsiva
- Ikke gravid eller ammende
- Negativ graviditetstest
- Fertile pasienter må bruke effektiv prevensjon under og i 2 måneder etter avsluttet studiebehandling
FØR SAMTIDIG TERAPI:
Biologisk:
- Ingen samtidig rutinemessig cytokinstøtte
Kjemoterapi:
- Ikke spesifisert
Endokrin terapi:
- Ingen samtidige kortikosteroider bortsett fra økt intrakranielt trykk hos pasienter med CNS-svulster
Strålebehandling:
- Se Sykdomskarakteristikker
Kirurgi:
- Se Sykdomskarakteristikker
Annen:
- Ingen tidligere behandling for HGG eller DIPG
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 |
|---|---|
|
Eksperimentell: Kjemoradioterapi
|
Hva måler studien?
Primære resultatmål
Resultatmål |
|---|
|
Forbedret resultat
|
|
Toksisitet vurdert av NCI CTCAE v. 2.0
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Kenneth J. Cohen, MD, MBA, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
Generelle publikasjoner
- Pollack IF, Hamilton RL, Burger PC, Brat DJ, Rosenblum MK, Murdoch GH, Nikiforova MN, Holmes EJ, Zhou T, Cohen KJ, Jakacki RI; Children's Oncology Group. Akt activation is a common event in pediatric malignant gliomas and a potential adverse prognostic marker: a report from the Children's Oncology Group. J Neurooncol. 2010 Sep;99(2):155-63. doi: 10.1007/s11060-010-0297-3. Epub 2010 Jul 4.
- Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Nikiforov YE, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Gilles FH, Yates AJ, Zhou T, Cohen KJ, Finlay JL, Jakacki RI; Children's Oncology Group. Mismatch repair deficiency is an uncommon mechanism of alkylator resistance in pediatric malignant gliomas: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Dec 1;55(6):1066-71. doi: 10.1002/pbc.22634.
- Cohen KJ, Heideman RL, Zhou T, Holmes EJ, Lavey RS, Bouffet E, Pollack IF. Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group. Neuro Oncol. 2011 Apr;13(4):410-6. doi: 10.1093/neuonc/noq205. Epub 2011 Feb 22.
- Cohen KJ, Pollack IF, Zhou T, Buxton A, Holmes EJ, Burger PC, Brat DJ, Rosenblum MK, Hamilton RL, Lavey RS, Heideman RL. Temozolomide in the treatment of high-grade gliomas in children: a report from the Children's Oncology Group. Neuro Oncol. 2011 Mar;13(3):317-23. doi: 10.1093/neuonc/noq191.
- Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. doi: 10.1002/cncr.22961.
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. desember 2002
Primær fullføring (Faktiske)
1. september 2007
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
4. januar 2002
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. februar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Glioma
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Astrocytom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Temozolomid
Andre studie-ID-numre
- ACNS0126
- COG-ACNS0126 (Annen identifikator: Children's Oncology Group)
- CDR0000069135 (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. .