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Kombination kemoterapi plus strålebehandling til behandling af patienter med metastatisk rhabdomyosarkom eller sarkom

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

Et fase II "Up-Front Window Study" af Irinotecan (CPT-11) efterfulgt af multimodal, multiagent, terapi til udvalgte børn og unge med nydiagnosticeret trin 4/klinisk gruppe IV rhabdomyosarkom: En IRS-V undersøgelse

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. Strålebehandling bruger højenergi røntgenstråler til at beskadige tumorceller. Kombination af mere end ét kemoterapilægemiddel med strålebehandling kan dræbe flere tumorceller.

FORMÅL: Fase II-forsøg til undersøgelse af effektiviteten af kombinationskemoterapi kombineret med strålebehandling til behandling af patienter, der har metastatisk rhabdomyosarkom eller sarkom.

Studieoversigt

Status

Afsluttet

Betingelser

Sarkom

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Bestem responsraten for patienter med nyligt diagnosticeret højrisiko metastatisk stadium IV/klinisk gruppe IV rhabdomyosarkom behandlet med forudgående vinduesbehandling omfattende irinotecan og vincristin.
Bestem de toksiske virkninger af denne behandling hos disse patienter.
Bestem de toksiske virkninger af dette regime, når det gives i alternerende forløb med vincristin, dactinomycin og cyclophosphamid (VAC) som fortsættelsesterapi hos patienter med delvis eller fuldstændig respons.
Bestem den samlede og fejlfrie overlevelse af patienter behandlet med irinotecan og vincristin efterfulgt af VAC alene eller VAC alternerende med vincristin og irinotecan plus strålebehandling.
Bestem farmakokinetikken af irinotecan og vincristin hos disse patienter.

OMRIDS:

Forudgående vinduesbehandling: Patienterne får vincristin IV på dag 1 og 8 og irinotecan IV over 60 minutter på dag 1-5 og 8-12. Behandlingen gentages hver 21. dag i i alt 2 forløb. Patienter, der oplever delvis eller fuldstændig respons, fortsætter til kur A. Patienter, der oplever stabil eller progressiv sygdom, fortsætter til kur B.
- Regime A: Patienterne får vincristin IV over 1 minut ugentligt i uge 6-13, 15-19, 23-27, 29, 32-35, 38-39 og 41; dactinomycin IV over 1 minut ugentligt i uge 6, 12, 23, 29, 35 og 41; og cyclophosphamid IV over 30-60 minutter ugentligt i uge 6, 12, 16, 19, 23, 29, 35 og 41. Patienter får også irinotecan IV over 1 time dagligt, 5 dage om ugen, i uge 9, 10, 26, 27, 32, 33, 38 og 39 og gennemgår strålebehandling dagligt, 5 dage om ugen, i uge 15-22.
- Regime B: Patienter modtager vincristin som i behandlingsregime A; dactinomycin IV over 1 minut ugentligt i uge 6, 9, 12, 23, 26, 29, 32, 35, 38 og 41 og cyclophosphamid IV over 30-60 minutter ugentligt i uge 6, 9, 12, 16, 19, 23 , 26, 29, 32, 35, 38 og 41. Patienter modtager strålebehandling som i regime A.

Patienter, der ikke modtager irinotecan/vincristinbehandling på forhånd, behandles med standardterapi.

Standardbehandling: Patienter får vincristin IV over 1 minut ugentligt i uge 0-13, 15-19, 23-27, 29, 32-35, 38 og 41; dactinomycin IV over 1 minut ugentligt i uge 0, 6, 9, 12, 23, 26, 29, 32, 35, 38 og 41; og cyclophosphamid IV over 30-60 minutter ugentligt i uge 0, 3, 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38 og 41. Patienter uden tegn på intrakraniel forlængelse modtager strålebehandling én gang dagligt, 5 dage om ugen, i uge 15-22. Patienter med tegn på intrakraniel forlængelse, eller som har behov for akut strålebehandling, modtager strålebehandling i uge 0-6. Dactinomycin tilbageholdes under strålebehandling.

Alle patienter får filgrastim (G-CSF) eller sargramostim (GM-CSF) subkutant (SC) begyndende 24 timer efter afslutningen af hvert kemoterapiforløb og fortsætter, indtil blodtallene genoprettes. Alternativt kan patienter få pegfilgrastim SC begyndende 24-36 timer efter afslutning af hvert kemoterapiforløb og fortsætte, indtil blodtallene er genoprettet.

Patienterne følges hver 2. måned i 1 år, hver 4. måned i 2 år og derefter årligt.

PROJEKTERET TILSLUTNING: I alt 18-46 patienter vil blive akkumuleret til denne undersøgelse inden for 9-24 måneder.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

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
    - McMaster Children's Hospital at Hamilton Health Sciences
  - 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
    - Hôpital Sainte Justine
  - Montreal, Quebec, Canada, H3G 1A4
    - McGill University Health Center - Montreal Children's Hospital
  - Sainte Foy, Quebec, Canada, GIV 4G2
    - Centre de Recherche du Centre Hospitalier de l'Universite Laval
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
  - 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 Cancer Research Institute
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85016
    - Phoenix Children's Hospital
  - Tucson, Arizona, Forenede Stater, 85724
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Arkansas Cancer Research Center at 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 Cancer Institute at Loma Linda University Medical Center
  - Long Beach, California, Forenede Stater, 90801-1428
    - Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  - Los Angeles, California, Forenede Stater, 90048
    - Cedars-Sinai Comprehensive Cancer Center at 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 and Research Center at Oakland
  - Orange, California, Forenede Stater, 92868
    - Children's Hospital of Orange County
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  - Palo Alto, California, Forenede Stater, 94304
    - 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 - Sacramento
  - 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 and Health Center, San Diego
  - San Francisco, California, Forenede Stater, 94115
    - 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
    - Presbyterian - St. Luke's Medical Center
- Connecticut
  - Farmington, Connecticut, Forenede Stater, 06360-7106
    - University of Connecticut Comprehensive Cancer Center at 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 Hospital for Children
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20007
    - Lombardi Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, Forenede Stater, 20010-2970
    - Children's National Medical Center
  - Washington, District of Columbia, Forenede Stater, 20307-5001
    - Walter Reed Army Medical 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, 32610-0296
    - Shands Cancer Center at the University of Florida Health Science Center
  - 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, 33155
    - Miami Children's Hospital
  - Miami, Florida, Forenede Stater, 33136
    - Jackson Memorial Hospital
  - Orlando, Florida, Forenede Stater, 32804
    - 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
    - St. Joseph's Children's Hospital
  - West Palm Beach, Florida, Forenede Stater, 33407
    - St. Mary's Hospital
- Georgia
  - 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, 30912-4000
    - MBCCOP-Medical College of Georgia Cancer Center
  - Macon, Georgia, Forenede Stater, 31201
    - Medical Center of Central Georgia
  - Savannah, Georgia, Forenede Stater, 31405
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- 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 - Boise
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush University Medical Center
  - Chicago, Illinois, Forenede Stater, 60614
    - Children's Memorial Hospital - Chicago
  - Chicago, Illinois, Forenede Stater, 60601
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Forenede Stater, 60612
    - University of Illinois Medical Center
  - Oak Lawn, Illinois, Forenede Stater, 60453
    - Advocate Hope Children's Hospital
  - Park Ridge, Illinois, Forenede Stater, 60068-1174
    - Lutheran General Cancer Care Center
  - 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, 46260
    - St. Vincent Hospital and Health Care Center
  - Indianapolis, Indiana, Forenede Stater, 46202-5225
    - Riley Children Cancer Center at Riley Hospital for Children
- Iowa
  - Des Moines, Iowa, Forenede Stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forenede Stater, 50308
    - Blank Children's Hospital
  - Iowa City, Iowa, Forenede Stater, 52242-1009
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Wichita, Kansas, Forenede Stater, 67214
    - Wesley Medical Center
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40536-0284
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
  - Louisville, Kentucky, Forenede Stater, 40202-3830
    - Kosair Children's Hospital
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70121
    - Ochsner Clinic Foundation
  - New Orleans, Louisiana, Forenede Stater, 70118
    - Children's Hospital of New Orleans
  - New Orleans, Louisiana, Forenede Stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Tulane Cancer Center at Tulane University Hospital and Clinic
- Maine
  - Bangor, Maine, Forenede Stater, 04401
    - Eastern Maine Medical Center
  - Scarborough, Maine, Forenede Stater, 04074-9308
    - Maine Children's Cancer Program
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, Forenede Stater, 21225
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, Forenede Stater, 21201-1595
    - 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
  - Boston, Massachusetts, Forenede Stater, 02111
    - Floating Hospital for Children
  - Springfield, Massachusetts, Forenede Stater, 01107
    - Baystate Regional Cancer Program at Baystate Medical Center
  - Worcester, Massachusetts, Forenede Stater, 01655
    - University of Massachusetts Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109-0914
    - University of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Forenede Stater, 48201
    - Children's Hospital of Michigan
  - Detroit, Michigan, Forenede Stater, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Detroit, Michigan, Forenede Stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - 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, 49007-5364
    - Bronson Methodist Hospital
  - Lansing, Michigan, Forenede Stater, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Royal Oak, Michigan, Forenede Stater, 48073-6769
    - CCOP - Beaumont
  - Royal Oak, Michigan, Forenede Stater, 48073-6769
    - William Beaumont Hospital - Royal Oak
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55805
    - 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 - 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
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89109
    - Sunrise Hospital and Medical Center
- New Hampshire
  - Lebanon, New Hampshire, Forenede Stater, 03756
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- New Jersey
  - Hackensack, New Jersey, Forenede Stater, 07601
    - Cancer Center at Hackensack University Medical Center
  - New Brunswick, New Jersey, Forenede Stater, 08903
    - Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
  - 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
    - Valerie Fund Children's Center at Atlantic Health
- 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, 11203
    - SUNY Downstate Medical Center
  - Brooklyn, New York, Forenede Stater, 11212
    - Brookdale University Hospital and Medical Center
  - Brooklyn, New York, Forenede Stater, 11201-5493
    - Brooklyn Hospital Center
  - Brooklyn, New York, Forenede Stater, 11219
    - Comprehensive Cancer Center at Maimonides 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
    - New York Weill Cornell Cancer Center at Cornell University
  - New York, New York, Forenede Stater, 10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Stony Brook, New York, Forenede Stater, 11794
    - Long Island Cancer Center at Stony Brook University Hospital
  - Syracuse, New York, Forenede Stater, 13210
    - University Hospital at 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 Hospitals
  - 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
    - Presbyterian Healthcare
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke Comprehensive Cancer Center
  - Greenville, North Carolina, Forenede Stater, 27858-4354
    - Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
  - 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 at Innovis Health - Dakota Clinic
- Ohio
  - Akron, Ohio, Forenede Stater, 44308
    - Children's Hospital Medical Center of Akron
  - 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, 44106-5065
    - 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 at Oklahoma University Medical Center
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - Natalie Warren Bryant Cancer Center
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - CCOP - Oklahoma
- Oregon
  - Portland, Oregon, Forenede Stater, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Forenede Stater, 97227
    - Legacy Emanuel Hospital and Health Center & Children's Hospital
  - Portland, Oregon, Forenede Stater, 97239-3098
    - Doernbecher Children's Hospital at Oregon Health & Science University
- Pennsylvania
  - Danville, Pennsylvania, Forenede Stater, 17822-1320
    - Geisinger Medical Center
  - Hershey, Pennsylvania, Forenede Stater, 17033
    - Penn State Cancer Institute at 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, 15213-2583
    - Children's Hospital of Pittsburgh
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02903
    - Rhode Island Hospital
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425-0721
    - Hollings Cancer Center at 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, 57117-5039
    - Sioux Valley Hospital at University of South Dakota Medical Center
- Tennessee
  - Johnson City, Tennessee, Forenede Stater, 37604
    - East Tennessee State University Cancer Center at Johnson City Medical Center
  - Knoxville, Tennessee, Forenede Stater, 37901
    - East Tennessee Children's Hospital
  - Memphis, Tennessee, Forenede Stater, 38105-2794
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Forenede Stater, 37232-6310
    - Vanderbilt Children's Hospital
- 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, 75390-9063
    - Simmons Cancer Center at University of Texas Southwestern Medical 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
    - 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, 78229-3900
    - MBCCOP - South Texas Pediatrics
  - San Antonio, Texas, Forenede Stater, 78229-3902
    - Methodist Cancer Center at Methodist Specialty and Transplant Hospital
  - Temple, Texas, Forenede Stater, 76508
    - CCOP - Scott and White Hospital
  - Temple, Texas, Forenede Stater, 76508
    - Center for Cancer Prevention and Care at Scott and White Clinic
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84112
    - Huntsman Cancer Institute
- Vermont
  - Burlington, Vermont, Forenede Stater, 05401-3498
    - Vermont Cancer Center at University of Vermont
- 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, 23298-0121
    - Massey Cancer Center at Virginia Commonwealth University
  - Roanoke, Virginia, Forenede Stater, 24029
    - 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 Central Hospital
  - 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 Hospital and Health Center
- West Virginia
  - Charleston, West Virginia, Forenede Stater, 25302
    - West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  - Huntington, West Virginia, Forenede Stater, 25701
    - Cabell Huntington Hospital
  - 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 Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Forenede Stater, 53792-6164
    - University of Wisconsin Comprehensive Cancer Center
  - Marshfield, Wisconsin, Forenede Stater, 54449-5772
    - Marshfield Clinic
  - Marshfield, Wisconsin, Forenede Stater, 54449
    - CCOP - Marshfield Clinic Research Foundation
  - 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
    - Puerto Rico Cancer Center at University of Puerto Rico - 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 49 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

Histologisk bekræftet metastatisk stadium IV/klinisk gruppe IV rhabdomyosarkom, udifferentieret sarkom eller ektomesenchymom
- Ingen metastaserende embryonale tumorer hos patienter under 10 år, uanset det primære sted
- Metastatiske tumorer af parameningeale steder kvalificerede
Bidimensionelt målbar sygdom
Ingen positiv cerebrospinalvæskecytologi eller multiple intrakranielle metastaser
Patienter med følgende er kun berettigede til fortsat behandling og får muligvis ikke irinotecan/vincristin-behandling på forhånd:
- Tegn på bunden af kranieerosion eller kraniemetastatisk sygdom, der fortrænger eller indskærer duraen, komprimerer hjerneparenkymet eller forårsager tegn på kranienerveparese
- Tumor, der rører eller fortrænger rygmarven
- Bevis på intrakraniel primær tumorforlængelse
- Tumorer, der kan forårsage potentielt livstruende komplikationer (f.eks. nyre, luftveje) med progression på grund af placering og/eller væksthastighed
- Kræver akut strålebehandling
- Laboratorieværdier stemmer overens med dissemineret intravaskulær koagulation

PATIENT KARAKTERISTIKA:

Alder:

Under 50 (alveolær rhabdomyosarkom, udifferentieret sarkom og ektomesenchymompatienter)
10 til 49 (embryonale histologiske patienter)

Ydeevnestatus:

Ikke specificeret

Forventede levealder:

Ikke specificeret

Hæmatopoietisk:

Se Sygdomskarakteristika
Absolut neutrofiltal større end 1.000/mm^3*
Blodpladetal større end 150.000/mm^3* BEMÆRK: *Medmindre der er tumorinvolvering af knoglemarv

Hepatisk:

Bilirubin mindre end 1,5 mg/dL
PT, PTT og fibrinogen mindre end 1,5 gange øvre normalgrænse

Nyre:

Kreatinin mindre end 1,2 mg/dL

Andet:

Ikke gravid eller ammende
Fertile patienter skal bruge effektiv prævention

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

Ikke specificeret

Kemoterapi:

Ingen forudgående kemoterapi

Endokrin terapi:

Tidligere steroider tilladt

Strålebehandling:

Se Sygdomskarakteristika
Ingen forudgående strålebehandling

Kirurgi:

Ikke mere end 42 dage siden forudgående indledende kirurgisk indgreb, inklusive biopsi til diagnose

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
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Begivenhedsfri overlevelse

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: Alberto S. Pappo, MD, Texas Children's 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. september 1999

Primær færdiggørelse (Faktiske)

1. januar 2005

Studieafslutning (Faktiske)

1. oktober 2009

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)

14. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

D9802
COG-D9802 (Anden identifikator: Children's Oncology Group)
IRS-D9802 (Anden identifikator: Intergroup Rhabdosarcoma Group)
CCG-D9802 (Anden identifikator: Children's Cancer Group)
POG-D9802 (Anden identifikator: Pediatric Oncology Group)
CDR0000067154 (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 .