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Kombination af kemoterapi til behandling af børn med progressive hjernetumorer

6. september 2013 opdateret af: Children's Oncology Group

Kemoterapi for progressivt lavgradigt astrocytom hos børn under ti år

RATIONALE: Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at forhindre tumorceller i at dele sig, så de holder op med at vokse eller dør. Kombination af mere end et lægemiddel kan dræbe flere tumorceller.

FORMÅL: Dette randomiserede fase III-forsøg studerer to forskellige kombinationskemoterapiregimer og sammenligner, hvor godt de virker ved behandling af børn med lavgradige astrocytomer eller andre resterende tumorer i hjernen.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

  • Sammenlign hændelsesfri overlevelse som et resultat af behandling med carboplatin og vincristin versus thioguanin, procarbazin, lomustin og vincristin hos børn med progressive hjernetumorer.
  • Estimer tumorresponsrater på hvert kemoterapiregime hos disse patienter.
  • Bestem toksiske virkninger og livskvalitet for børn, der behandles med hvert kemoterapiregime.
  • Undersøg biologiske og kliniske faktorer, som kan forudsige tumorrespons og tidlig progression (tumorstørrelse, placering, patologisk subtype, cytogenetik og proliferativt indeks ved MIB-1 (Ki67)) hos disse patienter.
  • Undersøg faktorer, der bidrager til neuropsykologisk og endokrin status hos børn med hjernetumorer behandlet uden bestråling.

OVERSIGT: Dette er en randomiseret undersøgelse. Patienterne er stratificeret efter sygdomssted, status ved indrejse og patologi. Patienterne randomiseres til en af ​​to behandlingsarme. Patienter med neurofibromatose tildeles ikke tilfældigt til arm II.

  • Arm I: Patienterne får induktion med carboplatin og vincristin i 10 uger efterfulgt af 2 ugers hvile. Induktion efterfølges af 8 vedligeholdelsesforløb begyndende på dag 84 af induktion eller ved hæmatopoietisk genopretning. Hvert forløb består af 4 ugentlige doser carboplatin og 3 ugentlige doser vincristin (givet samtidig med de første 3 ugers carboplatin), efterfulgt af 2 ugers hvile.
  • Arm II: Patienterne får oral thioguanin, procarbazin og lomustin på dag 0-4, efterfulgt af vincristin IV på dag 14 og 28. Behandlingen fortsætter hver 6. uge i maksimalt 8 forløb.

PROJEKTERET OPSLAG: I alt vil 280-340 patienter blive optjent over 4 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

428

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • New South Wales
      • Newcastle, New South Wales, Australien, 2310
        • John Hunter Hospital
      • Randwick, New South Wales, Australien, 2031
        • Prince of Wales Private Hospital
      • Westmead, New South Wales, Australien, 2145
        • Children's Hospital at Westmead
    • Queensland
      • Brisbane, Queensland, Australien, 4029
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Québec
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • London, Ontario, Canada, N6A 5W9
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • University of South Alabama Mitchell Cancer Institute
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016-7710
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, Forenede Stater, 90027
        • Southern California Permanente Medical Group
      • Duarte, California, Forenede Stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Forenede Stater, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, Forenede Stater, 90027
        • Childrens Hospital Los Angeles
      • Los Angeles, California, Forenede Stater, 90048-1865
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Madera, California, Forenede Stater, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Forenede Stater, 94609
        • Children's Hospital and Research Center Oakland
      • Orange, California, Forenede Stater, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Forenede Stater, 95798
        • Lucile Packard Children's Hospital at Stanford University Medical Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Cancer center
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, Forenede Stater, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Diego, California, Forenede Stater, 92123-4282
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • Santa Barbara, California, Forenede Stater, 93105
        • Santa Barbara Cottage Children's Hospital
      • Santa Clara, California, Forenede Stater, 95051-5386
        • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Center for Cancer and Blood Disorders
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
      • New Haven, Connecticut, Forenede Stater, 06520-8028
        • Yale Cancer Center
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19803
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010-2970
        • Children's National Medical Center
      • Washington, District of Columbia, Forenede Stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward General Medical Center Cancer Center
      • Fort Myers, Florida, Forenede Stater, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, Forenede Stater, 32610-0232
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, Forenede Stater, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Forenede Stater, 33155
        • Miami Children's Hospital
      • Miami, Florida, Forenede Stater, 33176
        • Baptist-South Miami Regional Cancer Program
      • Orlando, Florida, Forenede Stater, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Orlando, Florida, Forenede Stater, 32806
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, Forenede Stater, 32806
        • M.D. Anderson Cancer Center at Orlando
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Saint Petersburg, Florida, Forenede Stater, 33701
        • All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
      • Atlanta, Georgia, Forenede Stater, 30342
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
      • Augusta, Georgia, Forenede Stater, 30912-3730
        • MBCCOP - Medical College of Georgia Cancer Center
      • Macon, Georgia, Forenede Stater, 31208
        • Medical Center of Central Georgia
      • Savannah, Georgia, Forenede Stater, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712-6297
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, Forenede Stater, 60614
        • Children's Memorial Hospital - Chicago
      • Maywood, Illinois, Forenede Stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Keyser Family Cancer Center at Advocate Hope Children's Hospital
      • Park Ridge, Illinois, Forenede Stater, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Peoria, Illinois, Forenede Stater, 61637
        • Saint Jude Midwest Affiliate
      • Rockford, Illinois, Forenede Stater, 61104-2315
        • Swedish-American Regional Cancer Center
      • Springfield, Illinois, Forenede Stater, 62794-9677
        • Simmons Cooper Cancer Institute
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46260
        • St. Vincent Indianapolis Hospital
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, Forenede Stater, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Wichita, Kansas, Forenede Stater, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Wesley Medical Center
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
      • Louisville, Kentucky, Forenede Stater, 40232
        • Kosair Children's Hospital
    • Louisiana
      • Alexandria, Louisiana, Forenede Stater, 71315-3198
        • Tulane Cancer Center Office of Clinical Research
      • New Orleans, Louisiana, Forenede Stater, 70118
        • Children's Hospital of New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • CancerCare of Maine at Eastern Maine Medical Center
      • Scarborough, Maine, Forenede Stater, 04074-9308
        • Maine Children's Cancer Program at Barbara Bush Children's Hospital
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
      • Baltimore, Maryland, Forenede Stater, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
      • Springfield, Massachusetts, Forenede Stater, 01199-0001
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0286
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503-2560
        • Butterworth Hospital at Spectrum Health
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, Forenede Stater, 49007-5381
        • CCOP - Kalamazoo
      • Lansing, Michigan, Forenede Stater, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805-1983
        • CCOP - Duluth
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Masonic Cancer Center at University of Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
      • St. Paul, Minnesota, Forenede Stater, 55102-2392
        • Children's Hospitals and Clinics of Minnesota - St. Paul
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Cancer Clinic
      • Keesler AFB, Mississippi, Forenede Stater, 39534-2511
        • Keesler Air Force Base Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • St. Louis, Missouri, Forenede Stater, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114-4113
        • Children's Hospital
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109-2306
        • CCOP - Nevada Cancer Research Foundation
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center Cancer Center
      • Livingston, New Jersey, Forenede Stater, 07039
        • St. Barnabas Medical Center Cancer Center
      • Morristown, New Jersey, Forenede Stater, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Saint Peter's University Hospital
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Forenede Stater, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-5636
        • University of New Mexico Cancer Center
    • New York
      • Albany, New York, Forenede Stater, 12208-3419
        • Albany Medical Center Hospital
      • Bronx, New York, Forenede Stater, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, Forenede Stater, 11219
        • Maimonides Cancer Center at Maimonides Medical Center
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, Forenede Stater, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New Hyde Park, New York, Forenede Stater, 11040
        • Schneider Children's Hospital
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • New York, New York, Forenede Stater, 10003-3803
        • Beth Israel Medical Center - Petrie Division
      • New York, New York, Forenede Stater, 10027
        • St. Luke's - Roosevelt Hospital Center - St.Luke's Division
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, Forenede Stater, 11794-9446
        • Stony Brook University Cancer Center
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Forenede Stater, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, Forenede Stater, 58103-4940
        • Dakota Cancer Institute at Dakota Clinic - South University
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308-1062
        • Akron Children's Hospital
      • Cincinnati, Ohio, Forenede Stater, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Columbus, Ohio, Forenede Stater, 43205-2696
        • Nationwide Children's Hospital
      • Dayton, Ohio, Forenede Stater, 45404-1815
        • Dayton Children's - Dayton
      • Toledo, Ohio, Forenede Stater, 43606
        • Toledo Hospital
      • Toledo, Ohio, Forenede Stater, 43614
        • Medical University of Ohio Cancer Center
      • Youngstown, Ohio, Forenede Stater, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239-3098
        • Knight Cancer Institute at Oregon Health and Science University
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
        • St. Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-9786
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Children's Hospital of Pittsburgh of UPMC
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Palmetto Health South Carolina Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37901
        • East Tennessee Children's Hospital
      • Nashville, Tennessee, Forenede Stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
      • Austin, Texas, Forenede Stater, 78723
        • Dell Children's Medical Center of Central Texas
      • Corpus Christi, Texas, Forenede Stater, 78411
        • Driscoll Children's Hospital
      • Fort Worth, Texas, Forenede Stater, 76104
        • Cook Children's Medical Center - Fort Worth
      • Galveston, Texas, Forenede Stater, 77555-0361
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Lackland AFB, Texas, Forenede Stater, 78236-5300
        • Wilford Hall Medical Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Forenede Stater, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, Forenede Stater, 78207
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042-3300
        • Inova Fairfax Hospital
      • Norfolk, Virginia, Forenede Stater, 23507-1971
        • Children's Hospital of The King's Daughters
      • Portsmouth, Virginia, Forenede Stater, 23708-2197
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, Forenede Stater, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
      • Roanoke, Virginia, Forenede Stater, 24014
        • Carilion Medical Center for Children at Roanoke Community Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Central Hospital
      • Spokane, Washington, Forenede Stater, 99220-2555
        • Providence Cancer Center at Sacred Heart Medical Center
      • Spokane, Washington, Forenede Stater, 99210-0248
        • Deaconess Medical Center
      • Tacoma, Washington, Forenede Stater, 98405
        • Mary Bridge Children's Hospital and Health Center - Tacoma
      • Tacoma, Washington, Forenede Stater, 98431
        • Madigan Army Medical Center - Tacoma
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25302
        • West Virginia University Health Sciences Center - Charleston
      • Huntington, West Virginia, Forenede Stater, 25701
        • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
      • Morgantown, West Virginia, Forenede Stater, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic - Marshfield Center
  • Holland
      • Groningen, Holland, 9713 EZ
        • University Medical Center Groningen
  • New Zealand
      • Auckland, New Zealand, 1
        • Starship Children's Health
  • Schweiz
      • Bern, Schweiz, 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Schweiz, 1205
        • Swiss Pediatric Oncology Group Geneva

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 5 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

  • Patologisk bekræftede lavgradige resterende astrocytomer eller andre kvalificerede resterende tumorer i hjernen fortolket som lavgradige (WHO grad I og II), såsom følgende:

    • Glial tumorer

      • Astrocytiske tumorer

        • Lavgradigt astrocytom (varianter: fibrillært, protoplasmatisk, gemistocytisk)
        • Pilocytisk astrocytom
        • Pleomorfe xanthoastrocytomer
        • Subependymalt kæmpecelleastrocytom
        • Infantil desmoplastisk astrocytom

      • Lavgradige oligodendrogliale tumorer

        • Lavgradigt oligodendrogliom

      • Blandede gliomer af lav kvalitet

        • Oligo-astrocytom

    • Neuronale tumorer

      • Gangliogliom (eksklusive tumorer med anaplastiske astrocytiske komponenter)
      • Infantil desmoplastisk gangliogliom
    • Chiasmatisk-hypothalamus tumor uden histologisk bekræftelse
  • Alle de følgende diagnostiske tests (radiologiske eller kliniske tegn på progression, kirurgi eller bekræftende MR) skal udføres inden for 6 uger efter tilmelding til denne undersøgelse
  • Progressiv sygdom efter kirurgisk excision baseret på klare radiologiske eller kliniske tegn på progression, eller en ufuldstændig excision (mindre end 95 % eller mere end 1,5 cm2) med nødvendigheden af ​​at påbegynde behandling på grund af en risiko for neurologisk svækkelse med progression
  • Chiasmatiske læsioner, der har sammenhængende udvidelser af tumor ind i andre regioner af de visuelle veje påvist ved kontrast MR, vil være kvalificerede til undersøgelse uden histopatologisk bekræftelse
  • Patienter med neurofibromatose, som har røntgendiagnose af kiasmatisk-hypothalamus tumor er kvalificerede til undersøgelsen uden at kræve biopsibekræftelse af tumorhistologi, men ikke medmindre tumorprogression er dokumenteret radiografisk
  • Ingen iboende hjernestammetumorer i pons eller isolerede synsnervetumorer uden definitiv involvering af den optiske chiasme

PATIENT KARAKTERISTIKA:

Alder:

  • Under 10

Ydeevnestatus:

  • Ikke specificeret

Forventede levealder:

  • Ikke specificeret

Hæmatopoietisk:

  • Absolut neutrofiltal større end 1.000/mm^3 (arm II)
  • Blodpladetal større end 100.000/mm^3 (arm II)

Hepatisk:

  • Ikke specificeret

Nyre:

  • Kreatinin mindre end 1,5 gange øvre normalgrænse for alder ELLER
  • Kreatininclearance eller radioisotop GFR større end 70 ml/min eller tilsvarende GFR som bestemt af det institutionelle normalområde

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

  • Ikke specificeret

Kemoterapi:

  • Ingen forudgående kemoterapi for tumoren

Endokrin terapi:

  • Forudgående kortikosteroidbehandling tilladt

Strålebehandling:

  • Ingen forudgående strålebehandling af tumoren

Kirurgi:

  • Se Sygdomskarakteristika

Andet:

  • Forudgående diuretikabehandling tilladt

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Regime A (CV kemoterapi)
Induktion vil bestå af 10 ugers behandling (carboplatin, vincristinsulfat), efterfulgt af 2 uger uden kemoterapi. Induktion bør kun afbrydes i tilfælde af grad 3 neurotoksicitet, grad 2 renal toksicitet, grad 4 hæmatologisk toksicitet eller tumorprogression. Vedligeholdelse-fire forløb (2 cyklusser/kursus) begynder på dag 84 (uge 12) af induktion, eller når perifere tal genoprettes med ANC >1.000/$L og blodpladetal >100.000/$L. Hver cyklus vil bestå af 4 ugentlige doser carboplatin, tre ugentlige doser vincristinsulfat (givet samtidig med de første 3 ugers carboplatin), efterfulgt af to ugers hvile i i alt 6 uger. Vedligeholdelsen vil fortsætte i i alt 8 cyklusser.
Medicin: carboplatin
Givet IV
Andre navne:
  • Paraplatin
  • NSC-241240
Medicin: vincristinsulfat
Givet PO og IV
Andre navne:
  • Oncovin
  • NSC-675574
Eksperimentel: Regime B (TPCV kemoterapi)
Hver kemoterapicyklus består af 4 dages oral kemoterapi (thioguanin, procarbazinhydrochlorid, lomustin og vincristinsulfat begyndende dag 0, efterfulgt af vincristinsulfat IV på dag 14 og 28. Cyklusen gentages hver 6. uge (42 dage). Der vil blive givet i alt 8 cyklusser.
Medicin: vincristinsulfat
Givet PO og IV
Andre navne:
  • Oncovin
  • NSC-675574
Medicin: lomustin
Givet IV
Andre navne:
  • CCNU
  • NSC-79037
Medicin: procarbazinhydrochlorid
Givet PO
Andre navne:
  • Matulane
  • NSC-77213
Medicin: thioguanin
Givet PO
Andre navne:
  • 6-TG
  • NSC-752

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Begivenhedsfri overlevelse
Tidsramme: Tid fra studiestart til sygdomsprogression, død uden progression af sygdom, forekomst af en anden malign neoplasma eller sidste opfølgning, alt efter hvad der kommer først, vurderet op til 5 år
Sammenlign den hændelsesfrie overlevelse som følge af behandling med enten CV eller TPCV
Tid fra studiestart til sygdomsprogression, død uden progression af sygdom, forekomst af en anden malign neoplasma eller sidste opfølgning, alt efter hvad der kommer først, vurderet op til 5 år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overlevelse
Tidsramme: 5 år
Defineret som tidspunktet for død af enhver årsag.
5 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Joann Ater, MD, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 1997

Primær færdiggørelse (Faktiske)

1. februar 2006

Studieafslutning (Faktiske)

1. april 2012

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A9952
  • CCG-A9952 (Anden identifikator: Children's Cancer Group)
  • POG-A9952 (Anden identifikator: Pediatric Oncology Group)
  • CCG-9952 (Anden identifikator: Clinical Trials.gov)
  • CDR0000065394 (Anden identifikator: Clinical Trials.gov)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjernetumorer

Kliniske forsøg med carboplatin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Thailand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner