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STI571 i behandling af patienter med tilbagevendende leukæmi

20. februar 2014 opdateret af: Children's Oncology Group

Et fase I-studie af STI571 i Ph+ leukæmi

RATIONALE: Imatinibmesylat kan forstyrre væksten af ​​kræftceller og kan være en effektiv behandling af leukæmi.

FORMÅL: Fase I-forsøg til undersøgelse af effektiviteten af ​​imatinibmesylat til behandling af patienter, der har tilbagevendende leukæmi.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

  • Bestem den maksimalt tolererede dosis og dosisbegrænsende toksicitet af imatinibmesylat hos patienter med tilbagevendende Philadelphia-kromosompositiv leukæmi.
  • Karakteriser den farmakokinetiske adfærd af dette lægemiddel i denne patientpopulation.
  • Bestem foreløbigt den antileukæmiske aktivitet af dette lægemiddel hos disse patienter.

OVERSIGT: Dette er en dosis-eskalerende, multicenter undersøgelse.

Patienterne får oralt imatinibmesylat (STI571) én gang dagligt i 28 dage. Behandlingen fortsætter i fravær af uacceptabel toksicitet eller sygdomsprogression.

Kohorter på 3-6 patienter modtager eskalerende doser af STI571, indtil den maksimalt tolererede dosis (MTD) er bestemt. MTD er defineret som den dosis, der går forud for den, ved hvilken mindst 2 ud af 3 eller 2 ud af 6 patienter oplever dosisbegrænsende toksicitet.

Patienterne følges hver 6. måned i 4 år og derefter årligt.

PROJEKTERET TILSLUTNING: Der vil maksimalt blive akkumuleret 32 ​​patienter til denne undersøgelse inden for 3,5 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • Sydney Children's Hospital
      • Westmead, New South Wales, Australien, 2145
        • Children's Hospital at Westmead
    • Queensland
      • Brisbane, Queensland, Australien, 4029
        • Royal Children's Hospital
    • South Australia
      • North Adelaide, South Australia, Australien, 5006
        • Women's and Children's Hospital
    • Victoria
      • Parkville, Victoria, Australien, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
    • 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
        • Children's Hospital
      • London, Ontario, Canada, N6C 2V5
        • 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, H3T 1C5
        • Hopital Sainte Justine
      • Montreal, Quebec, Canada, H3H 1P3
        • McGill University Health Center - Montreal Children's Hospital
      • Sainte Foy, Quebec, Canada, GIV 4G2
        • Centre Hospitalier de l'Université Laval
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • Laval University Medical Center
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Mobile, Alabama, Forenede Stater, 36604
        • University of South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016-7710
        • Phoenix Children's Hospital
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Downey, California, Forenede Stater, 90242
        • Southern California Permanente Medical Group
      • Duarte, California, Forenede Stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, Forenede Stater, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Medical Center
      • Long Beach, California, Forenede Stater, 90801-1428
        • Jonathan Jaques Children'S Cancer Center
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forenede Stater, 90027-0700
        • Children's Hospital Los Angeles
      • Madera, California, Forenede Stater, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Forenede Stater, 94609-1809
        • Children's Hospital of Oakland
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center
      • Orange, California, Forenede Stater, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Forenede Stater, 94304
        • Lucile Packard Children's Hospital at Stanford
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Cancer center
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Medical Center
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
      • San Diego, California, Forenede Stater, 92123-4282
        • Children's Hospital San Diego
      • San Francisco, California, Forenede Stater, 94115
        • Kaiser Permanente Medical Center - San Francisco Geary Campus
      • San Francisco, California, Forenede Stater, 94143-0128
        • UCSF Comprehensive Cancer Center
      • Santa Barbara, California, Forenede Stater, 93102
        • Santa Barbara Cottage Hospital
      • Santa Clara, California, Forenede Stater, 95051-5386
        • Kaiser Permanente Medical Center - Santa Clara
      • Travis Air Force Base, California, Forenede Stater, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218-1088
        • Children's Hospital of Denver
      • Denver, Colorado, Forenede Stater, 80218
        • Childhood Hematology/Oncology Associates
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian-St Luke's Medical Center
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06360-7106
        • University of Connecticut Health Center
      • New Haven, Connecticut, Forenede Stater, 06520-8028
        • Yale Comprehensive Cancer Center
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19899
        • Alfred I. Dupont Institute
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, Forenede Stater, 20010-2970
        • Children's National Medical Center
      • Washington, District of Columbia, Forenede Stater, 20007
        • Lombardi Cancer Center
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward General Medical Center
      • Fort Myers, Florida, Forenede Stater, 33908
        • Children's Hospital of Southwest Florida
      • Gainesville, Florida, Forenede Stater, 32610-100277
        • Shands Hospital and Clinics, University of Florida
      • Hollywood, Florida, Forenede Stater, 33021
        • Joe DiMaggio Children's Hospital at Memorial
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Forenede Stater, 33176-2197
        • Baptist Hospital of Miami
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami-Jackson Memorial Hospital
      • Miami, Florida, Forenede Stater, 33155-4069
        • Miami Children's Hospital
      • Orlando, Florida, Forenede Stater, 32803
        • Florida Hospital Cancer Institute
      • Orlando, Florida, Forenede Stater, 32806
        • Nemours Children's Clinic-Orlando
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Children's Hospital
      • St. Petersburg, Florida, Forenede Stater, 33701
        • All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33677-4227
        • Tampa Children's Hospital
      • West Palm Beach, Florida, Forenede Stater, 33407
        • St. Mary's Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital - Atlanta
      • Atlanta, Georgia, Forenede Stater, 30342
        • Children's Healthcare of Atlanta - Scottish Rite
      • Augusta, Georgia, Forenede Stater, 30912-4000
        • Medical College of Georgia Comprehensive Cancer Center
      • Macon, Georgia, Forenede Stater, 31201
        • Medical Center of Central Georgia
      • Savannah, Georgia, Forenede Stater, 31403-3089
        • Memorial Health University Medical Center, Inc.
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • MBCCOP - Hawaii
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Mountain States Tumor Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, Forenede Stater, 60614
        • Children's Memorial Hospital - Chicago
      • Chicago, Illinois, Forenede Stater, 60601
        • University of Chicago Cancer Research Center
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Hope Children's Hospital
      • Park Ridge, Illinois, Forenede Stater, 60068-1174
        • Lutheran General Hospital
      • Peoria, Illinois, Forenede Stater, 61637
        • Saint Jude Midwest Affiliate
      • Springfield, Illinois, Forenede Stater, 62794-9658
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46260
        • St. Vincent Hospital and Health Care Center
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50308
        • Raymond Blank Memorial Hospital for Children
      • Des Moines, Iowa, Forenede Stater, 50309
        • John Stoddard Cancer Center
      • Iowa City, Iowa, Forenede Stater, 52242-1009
        • Holden Comprehensive Cancer Center
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Wesley Medical Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0284
        • Albert B. Chandler Medical Center, University of Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202-3830
        • Kosair Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70118
        • Children's Hospital of New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
      • Scarborough, Maine, Forenede Stater, 04074
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, Forenede Stater, 21201-1595
        • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
      • Baltimore, Maryland, Forenede Stater, 21225
        • Sinai Hospital of Baltimore
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02111
        • Floating Hospital for Children
      • Springfield, Massachusetts, Forenede Stater, 01107
        • Baystate Medical Center
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0914
        • Mott Children's Hospital
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201
        • Children's Hospital of Michigan
      • Detroit, Michigan, Forenede Stater, 48236
        • St. John Hospital and Medical Center
      • East Lansing, Michigan, Forenede Stater, 48824
        • Michigan State University
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health and DeVos Children's Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073-6769
        • CCOP - Beaumont
      • Royal Oak, Michigan, Forenede Stater, 48073-6769
        • William Beaumont Hospital
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805-1983
        • St. Mary's/Duluth Clinic Cancer Center
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Children's Hospitals and Clinics - Minneapolis
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • Children's Hospitals And Clinics Of Minnesota
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, Forenede Stater, 63110
        • St. Louis Children's Hospital
      • Saint Louis, Missouri, Forenede Stater, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Children's Hospital of Omaha
      • Omaha, Nebraska, Forenede Stater, 68198-2168
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109-2306
        • Sunrise Hospital and Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Cancer Institute Of New Jersey
      • Newark, New Jersey, Forenede Stater, 07112-2094
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Forenede Stater, 07503
        • St. Joseph's Hospital and Medical Center
      • Summit, New Jersey, Forenede Stater, 07901
        • Atlantic Health System
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Cancer Center of Albany Medical Center
      • Bronx, New York, Forenede Stater, 10461
        • Albert Einstein Clinical Cancer Center
      • Brooklyn, New York, Forenede Stater, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, Forenede Stater, 11201
        • Brooklyn Hospital Center
      • Brooklyn, New York, Forenede Stater, 11203
        • State University of New York Health Science Center at Brooklyn College of Medicine
      • Brooklyn, New York, Forenede Stater, 11212
        • Brookdale University Hospital and Medical Center
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University Hospital
      • New Hyde Park, New York, Forenede Stater, 11042
        • Schneider Children's Hospital
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Forenede Stater, 10021-4885
        • New York Presbyterian Hospital - Cornell Campus
      • New York, New York, Forenede Stater, 10032
        • Columbia Presbyterian Hospital
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center
      • Stony Brook, New York, Forenede Stater, 11790-7775
        • State University of New York Health Sciences Center - Stony Brook
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York - Upstate Medical University
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Saint Joseph's Health System
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Carolinas Medical Center
      • Charlotte, North Carolina, Forenede Stater, 28233-3549
        • Presbyterian Healthcare
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, Forenede Stater, 27858-4354
        • East Carolina University School of Medicine
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1081
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103-4940
        • Dakota Cancer Institute
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, Forenede Stater, 45229-3039
        • Children's Hospital Medical Center - Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, Forenede Stater, 43205-2696
        • Children's Hospital of Columbus
      • Dayton, Ohio, Forenede Stater, 45404
        • Children's Medical Center - Dayton
      • Toledo, Ohio, Forenede Stater, 43601
        • Toledo Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43608
        • St. Vincent Mercy Medical Center
      • Youngstown, Ohio, Forenede Stater, 44501
        • Forum Health-Tod Childrens Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Children's Hospital of Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • CCOP - Oklahoma
    • Oregon
      • Portland, Oregon, Forenede Stater, 97201-3098
        • Doernbecher Children's Hospital
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822-1320
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
        • St. Christopher's Hospital for Children
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02818
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425-0721
        • Medical University of South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29605
        • Children's Hospital of Greenville Hospital System
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105-1080
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117
        • Sioux Valley Hospital
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37604
        • East Tennessee State University Cancer Center at JCMC
      • Knoxville, Tennessee, Forenede Stater, 37901
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, Forenede Stater, 38105-2794
        • Saint Jude Children's Research 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
      • Austin, Texas, Forenede Stater, 78701
        • Children's Hospital of Austin
      • Dallas, Texas, Forenede Stater, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, Forenede Stater, 75235-9154
        • Simmons Cancer Center - Dallas
      • 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
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
        • San Antonio Military Pediatric Cancer and Blood Disorders Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Forenede Stater, 78207
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78229-3902
        • Methodist Health Care System
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401-3498
        • Vermont Cancer Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Cancer Center at the University of Virginia
      • Falls Church, Virginia, Forenede Stater, 22042-3300
        • Inova Fairfax Hospital
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hospital of The King's Daughters
      • Portsmouth, Virginia, Forenede Stater, 23708-5100
        • Naval Medical Center, Portsmouth
      • Richmond, Virginia, Forenede Stater, 23298-0037
        • Massey Cancer Center
      • Roanoke, Virginia, Forenede Stater, 24013
        • Carilion Medical Center for Children
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Seattle, Washington, Forenede Stater, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Cooperative
      • Spokane, Washington, Forenede Stater, 99210-0248
        • Deaconess Medical Center
      • Tacoma, Washington, Forenede Stater, 98431-5000
        • Madigan Army Medical Center
      • Tacoma, Washington, Forenede Stater, 98415-0299
        • Mary Bridge Children's Health Center
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25302
        • West Virginia University - Charleston
      • Huntington, West Virginia, Forenede Stater, 25701
        • Cabell-Huntington Hospital, Inc
      • Morgantown, West Virginia, Forenede Stater, 26506-9300
        • West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Bellin Memorial Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54307-9070
        • St. Vincent Hospital
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forenede Stater, 53792-0001
        • University of Wisconsin Hospital and Clinics
      • Marshfield, Wisconsin, Forenede Stater, 54449-5772
        • Marshfield Clinic
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Midwest Children's Cancer Center
  • Holland
      • Groningen, Holland, 9700 RB
        • Academisch Ziekenhuis Groningen
  • New Zealand
      • Auckland, New Zealand
        • Starship Children's Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico School of Medicine Medical Sciences Campus
      • Santurce, Puerto Rico, 00912
        • San Jorge Childrens Hospital
  • Schweiz
      • Bern, Schweiz, CH 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Schweiz, CH 1211
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Schweiz, CH 1011
        • Swiss Pediatric Oncology Group Lausanne

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 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

  • Tilbagevendende Philadelphia (Ph) kromosom-positiv leukæmi

    • Tilbagevendende eller refraktær akut lymfoblastisk eller myeloblastisk leukæmi ELLER

    • Kronisk myelogen leukæmi med resistens over for interferon alfa med et af følgende:

      • WBC mindst 20.000/mm^3 efter mindst 3 måneders interferonbehandling
      • Mindst 100 % stigning i WBC til mindst 20.000/mm^3 bekræftet over 2 uger under modtagelse af interferon alfa
      • Mindst 66 % Ph-kromosompositive celler efter 1 års interferonbehandling
      • Mindst 30 % stigning i antallet af Ph-kromosom-positive celler efter et interferon-induceret respons, mens interferonbehandlingen fortsætter

PATIENT KARAKTERISTIKA:

Alder:

  • Under 22

Ydeevnestatus:

  • Karnofsky 50-100% hvis over 10 år ELLER
  • Lansky 50-100% hvis 10 år og derunder

Forventede levealder:

  • Mindst 8 uger

Hæmatopoietisk:

  • Se Sygdomskarakteristika

Hepatisk:

  • Bilirubin ikke mere end 1,5 gange normalt
  • SGPT mindre end 3 gange normalt
  • Albumin større end 2 g/dL

Nyre:

  • Kreatinin ikke mere end 1,5 gange normal ELLER
  • Kreatininclearance eller radioisotop glomerulær filtrationshastighed mindst 70 ml/min

Andet:

  • Ikke gravid eller ammende
  • Negativ graviditetstest
  • Fertile patienter skal bruge effektiv prævention
  • Hvis forudgående allogen stamcelletransplantation, ingen ukontrolleret graft-versus-host-sygdom
  • Ingen anfaldssygdom, hvis du er på antikonvulsiva
  • Ingen ukontrolleret infektion
  • Ingen CNS-toksicitet større end grad 2

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

  • Se Sygdomskarakteristika
  • Mindst 1 uge siden tidligere biologisk behandling og restitueret
  • Mindst 3 måneder siden forudgående stamcelletransplantation (SCT)
  • Mindst 1 uge siden tidligere vækstfaktorer
  • Mindst 1 uge siden tidligere interferon alfa

Kemoterapi:

  • Kom sig efter tidligere kemoterapi
  • Mindst 6 uger siden tidligere busulfan og nitrosoureas
  • Mindst 2 uger siden tidligere homoharringtonin
  • Mindst 1 uge siden lavdosis cytarabin
  • Mindst 2 uger siden tidligere moderat dosis cytarabin
  • Mindst 4 uger siden tidligere højdosis cytarabin
  • Mindst 3 uger siden alle andre tidligere cytotoksiske kemoterapier
  • Ingen tidligere hydroxyurinstof

Endokrin terapi:

  • Skal være på en stabil dosis af steroider, hvis modtaget forud for allogen SCT

Strålebehandling:

  • Kom sig efter tidligere strålebehandling
  • Mindst 2 uger siden tidligere lokal palliativ strålebehandling (lille havn)
  • Mindst 6 måneder siden tidligere kraniospinal strålebehandling
  • Mindst 6 måneder siden forudgående strålebehandling til 50 % eller mere af bækkenet
  • Mindst 6 uger siden anden tidligere væsentlig knoglemarvsstrålebehandling

Kirurgi:

  • Ikke specificeret

Andet:

  • Ingen andre samtidige undersøgelsesmidler
  • Ingen samtidige antikonvulsiva

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 260 mg/m2 imatinibmesylat (ST571)
Medicin: imatinibmesylat
Andre navne:
  • CGP 57148
  • IND # 55666
Eksperimentel: 340 mg/m2 imatinibmesylat (ST571)
Medicin: imatinibmesylat
Andre navne:
  • CGP 57148
  • IND # 55666
Eksperimentel: 440 mg/m2 imatinibmesylat (ST571)
Medicin: imatinibmesylat
Andre navne:
  • CGP 57148
  • IND # 55666
Eksperimentel: 570 mg/m2 imatinibmesylat (ST571)
Medicin: imatinibmesylat
Andre navne:
  • CGP 57148
  • IND # 55666

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overlevelse
Tidsramme: Studielængde
At estimere den maksimalt tolererede dosis (MTD) af STI571 administreret oralt én gang dagligt uden afbrydelse til børn med recidiverende Ph+ leukæmi.
Studielængde

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dosisbegrænsende toksicitet
Tidsramme: Studielængde
For at bestemme de dosisbegrænsende toksiciteter (DLT) af STI571 givet på dette skema.
Studielængde
Karakteriser den farmakokinetiske adfærd
Tidsramme: Studielængde
At karakterisere den farmakokinetiske adfærd af STI571 hos børn med tilbagevendende Ph+ leukæmi.
Studielængde
Definer den anti-leukæmiske aktivitet af STI571
Tidsramme: Studielængde
Foreløbig at definere den anti-leukæmiske aktivitet af STI571 inden for rammerne af et fase I-studie.
Studielængde

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: Martin Champagne, MD, Hopital Sainte Justine

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. januar 2002

Primær færdiggørelse (Faktiske)

1. september 2005

Studieafslutning (Faktiske)

1. september 2005

Datoer for studieregistrering

Først indsendt

7. marts 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P9973
  • COG-P9973 (Anden identifikator: Children's Oncology Group)
  • POG-9973 (Anden identifikator: Pediatric Oncology Group)
  • CCG-P9973 (Anden identifikator: Children's Cancer Group)
  • CDR0000067616 (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 imatinibmesylat

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner