- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00003955
Kombinasjonskjemoterapi pluss strålebehandling ved behandling av pasienter med metastatisk rabdomyosarkom eller sarkom
En fase II "Up-Front Window Study" av irinotecan (CPT-11) etterfulgt av multimodal, multiagent, terapi for utvalgte barn og ungdommer med nylig diagnostisert stadium 4/klinisk gruppe IV rabdomyosarkom: en IRS-V-studie
BAKGRUNN: Legemidler som brukes i kjemoterapi bruker forskjellige måter å stoppe tumorceller i å dele seg slik at de slutter å vokse eller dør. Strålebehandling bruker høyenergi røntgenstråler for å skade tumorceller. Å kombinere mer enn ett kjemoterapimedikament med strålebehandling kan drepe flere tumorceller.
FORMÅL: Fase II-studie for å studere effektiviteten av kombinasjonskjemoterapi kombinert med strålebehandling ved behandling av pasienter som har metastatisk rabdomyosarkom eller sarkom.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
MÅL:
- Bestem responsraten til pasienter med nylig diagnostisert høyrisiko metastatisk stadium IV/klinisk gruppe IV rabdomyosarkom behandlet med forhåndsvindusbehandling som omfatter irinotekan og vinkristin.
- Bestem de toksiske effektene av dette regimet hos disse pasientene.
- Bestem de toksiske effektene av dette regimet når det gis i alternerende kurer med vinkristin, daktinomycin og cyklofosfamid (VAC) som fortsettelsesbehandling hos pasienter med delvis eller fullstendig respons.
- Bestem den totale og sviktfrie overlevelsen til pasienter behandlet med irinotekan og vincristin etterfulgt av VAC alene eller VAC alternerende med vincristin og irinotekan pluss strålebehandling.
- Bestem farmakokinetikken til irinotekan og vinkristin hos disse pasientene.
OVERSIKT:
Forhåndsvindusbehandling: Pasienter får vinkristin IV på dag 1 og 8 og irinotekan IV over 60 minutter på dag 1-5 og 8-12. Behandlingen gjentas hver 21. dag i totalt 2 kurer. Pasienter som opplever delvis eller fullstendig respons fortsetter til regime A. Pasienter som opplever stabil eller progressiv sykdom fortsetter til regime B.
- Regim A: Pasienter får vincristin IV over 1 minutt ukentlig i uke 6-13, 15-19, 23-27, 29, 32-35, 38-39 og 41; dactinomycin IV over 1 minutt ukentlig i uke 6, 12, 23, 29, 35 og 41; og cyklofosfamid IV over 30-60 minutter ukentlig i uke 6, 12, 16, 19, 23, 29, 35 og 41. Pasienter får også irinotekan IV over 1 time daglig, 5 dager i uken, i uke 9, 10, 26, 27, 32, 33, 38 og 39 og gjennomgår strålebehandling daglig, 5 dager i uken, i uke 15-22.
- Regime B: Pasienter får vincristin som i regime A; dactinomycin IV over 1 minutt ukentlig i uke 6, 9, 12, 23, 26, 29, 32, 35, 38 og 41 og cyklofosfamid IV over 30-60 minutter ukentlig i uke 6, 9, 12, 16, 19, 23 , 26, 29, 32, 35, 38 og 41. Pasienter får strålebehandling som i regime A.
Pasienter som ikke får irinotekan/vinkristinbehandling på forhånd, behandles med standardbehandling.
- Standardbehandling: Pasienter får vinkristin IV over 1 minutt ukentlig i ukene 0-13, 15-19, 23-27, 29, 32-35, 38 og 41; dactinomycin IV over 1 minutt ukentlig i uke 0, 6, 9, 12, 23, 26, 29, 32, 35, 38 og 41; og cyklofosfamid IV over 30-60 minutter ukentlig i uke 0, 3, 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38 og 41. Pasienter uten tegn på intrakraniell ekstensjon får strålebehandling én gang daglig, 5 dager i uken, i uke 15-22. Pasienter med tegn på intrakraniell ekstensjon, eller som trenger akutt strålebehandling, får strålebehandling i uke 0-6. Dactinomycin holdes tilbake under strålebehandling.
Alle pasienter får filgrastim (G-CSF) eller sargramostim (GM-CSF) subkutant (SC) fra og med 24 timer etter fullført hver kur med kjemoterapi og fortsetter til blodtellingen gjenoppretter seg. Alternativt kan pasienter få pegfilgrastim SC fra og med 24-36 timer etter fullført hver kjemoterapikur og fortsette til blodtellingen er gjenopprettet.
Pasientene følges hver 2. måned i 1 år, hver 4. måned i 2 år, og deretter årlig.
PROSJEKTERT PENGING: Totalt 18-46 pasienter vil bli påløpt for denne studien innen 9-24 måneder.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- Sydney Children's Hospital
-
Westmead, New South Wales, Australia, 2145
- Children's Hospital at Westmead
-
-
Queensland
-
Brisbane, Queensland, Australia, 4029
- Royal Children's Hospital
-
-
South Australia
-
North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital
-
-
Victoria
-
Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
-
-
Western Australia
-
Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
-
-
-
-
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
- Hopital 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
-
-
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35233
- University of Alabama at Birmingham Comprehensive Cancer Center
-
Mobile, Alabama, Forente stater, 36604
- University of South Alabama Cancer Research Institute
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85016
- Phoenix Children's Hospital
-
Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
-
-
California
-
Downey, California, Forente stater, 90242
- Southern California Permanente Medical Group
-
Duarte, California, Forente stater, 91010-3000
- City of Hope Comprehensive Cancer Center
-
La Jolla, California, Forente stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
-
Loma Linda, California, Forente stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
-
Long Beach, California, Forente stater, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
-
Los Angeles, California, Forente stater, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
-
Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, Forente stater, 90027-0700
- Children's Hospital Los Angeles
-
Madera, California, Forente stater, 93638-8762
- Children's Hospital Central California
-
Oakland, California, Forente stater, 94609-1809
- Children's Hospital and Research Center at Oakland
-
Orange, California, Forente stater, 92868
- Children's Hospital of Orange County
-
Orange, California, Forente stater, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
-
Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
-
Sacramento, California, Forente stater, 95816
- Sutter Cancer Center
-
Sacramento, California, Forente stater, 95817
- University of California Davis Cancer Center
-
Sacramento, California, Forente stater, 95825
- Kaiser Permanente Medical Center - Sacramento
-
San Diego, California, Forente stater, 92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
-
San Diego, California, Forente stater, 92123-4282
- Children's Hospital and Health Center, San Diego
-
San Francisco, California, Forente stater, 94115
- UCSF Comprehensive Cancer Center
-
Santa Barbara, California, Forente stater, 93102
- Santa Barbara Cottage Hospital
-
Santa Clara, California, Forente stater, 95051-5386
- Kaiser Permanente Medical Center - Santa Clara
-
Travis Air Force Base, California, Forente stater, 94535
- David Grant Medical Center
-
-
Colorado
-
Denver, Colorado, Forente stater, 80218-1088
- Children's Hospital of Denver
-
Denver, Colorado, Forente stater, 80218
- Presbyterian - St. Luke's Medical Center
-
-
Connecticut
-
Farmington, Connecticut, Forente stater, 06360-7106
- University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
-
New Haven, Connecticut, Forente stater, 06520-8028
- Yale Comprehensive Cancer Center
-
-
Delaware
-
Wilmington, Delaware, Forente stater, 19899
- Alfred I. DuPont Hospital for Children
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
-
Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical Center
-
Washington, District of Columbia, Forente stater, 20307-5001
- Walter Reed Army Medical Center
-
-
Florida
-
Fort Lauderdale, Florida, Forente stater, 33316
- Broward General Medical Center
-
Fort Myers, Florida, Forente stater, 33908
- Children's Hospital of Southwest Florida
-
Gainesville, Florida, Forente stater, 32610-0296
- Shands Cancer Center at the University of Florida Health Science Center
-
Hollywood, Florida, Forente stater, 33021
- Joe DiMaggio Children's Hospital at Memorial
-
Jacksonville, Florida, Forente stater, 32207
- Nemours Children's Clinic
-
Miami, Florida, Forente stater, 33176-2197
- Baptist Hospital of Miami
-
Miami, Florida, Forente stater, 33155
- Miami Children's Hospital
-
Miami, Florida, Forente stater, 33136
- Jackson Memorial Hospital
-
Orlando, Florida, Forente stater, 32804
- Florida Hospital Cancer Institute
-
Orlando, Florida, Forente stater, 32806
- Nemours Children's Clinic-Orlando
-
Pensacola, Florida, Forente stater, 32504
- Sacred Heart Children's Hospital
-
St. Petersburg, Florida, Forente stater, 33701
- All Children's Hospital
-
Tampa, Florida, Forente stater, 33677-4227
- St. Joseph's Children's Hospital
-
West Palm Beach, Florida, Forente stater, 33407
- St. Mary's Hospital
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
-
Augusta, Georgia, Forente stater, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
-
Macon, Georgia, Forente stater, 31201
- Medical Center of Central Georgia
-
Savannah, Georgia, Forente stater, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96859-5000
- Tripler Army Medical Center
-
Honolulu, Hawaii, Forente stater, 96813
- Cancer Research Center of Hawaii
-
Honolulu, Hawaii, Forente stater, 96813
- MBCCOP - Hawaii
-
-
Idaho
-
Boise, Idaho, Forente stater, 83712
- Mountain States Tumor Institute - Boise
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center
-
Chicago, Illinois, Forente stater, 60614
- Children's Memorial Hospital - Chicago
-
Chicago, Illinois, Forente stater, 60601
- University of Chicago Cancer Research Center
-
Chicago, Illinois, Forente stater, 60612
- University of Illinois Medical Center
-
Oak Lawn, Illinois, Forente stater, 60453
- Advocate Hope Children's Hospital
-
Park Ridge, Illinois, Forente stater, 60068-1174
- Lutheran General Cancer Care Center
-
Peoria, Illinois, Forente stater, 61637
- Saint Jude Midwest Affiliate
-
Springfield, Illinois, Forente stater, 62794-9658
- Southern Illinois University School of Medicine
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46260
- St. Vincent Hospital and Health Care Center
-
Indianapolis, Indiana, Forente stater, 46202-5225
- Riley Children Cancer Center at Riley Hospital for Children
-
-
Iowa
-
Des Moines, Iowa, Forente stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Forente stater, 50308
- Blank Children's Hospital
-
Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67214
- Wesley Medical Center
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
-
Louisville, Kentucky, Forente stater, 40202-3830
- Kosair Children's Hospital
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater, 70121
- Ochsner Clinic Foundation
-
New Orleans, Louisiana, Forente stater, 70118
- Children's Hospital of New Orleans
-
New Orleans, Louisiana, Forente stater, 70112
- MBCCOP - LSU Health Sciences Center
-
New Orleans, Louisiana, Forente stater, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
-
-
Maine
-
Bangor, Maine, Forente stater, 04401
- Eastern Maine Medical Center
-
Scarborough, Maine, Forente stater, 04074-9308
- Maine Children's Cancer Program
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
Baltimore, Maryland, Forente stater, 21225
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Forente stater, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
-
Boston, Massachusetts, Forente stater, 02111
- Floating Hospital for Children
-
Springfield, Massachusetts, Forente stater, 01107
- Baystate Regional Cancer Program at Baystate Medical Center
-
Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Memorial Medical Center - University Campus
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109-0914
- University of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
-
Detroit, Michigan, Forente stater, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
-
Detroit, Michigan, Forente stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
-
Grand Rapids, Michigan, Forente stater, 49503
- Spectrum Health and DeVos Children's Hospital
-
Kalamazoo, Michigan, Forente stater, 49007-5364
- Bronson Methodist Hospital
-
Lansing, Michigan, Forente stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
-
Royal Oak, Michigan, Forente stater, 48073-6769
- CCOP - Beaumont
-
Royal Oak, Michigan, Forente stater, 48073-6769
- William Beaumont Hospital - Royal Oak
-
-
Minnesota
-
Duluth, Minnesota, Forente stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
-
Minneapolis, Minnesota, Forente stater, 55404
- Children's Hospitals and Clinics - Minneapolis
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
-
Saint Paul, Minnesota, Forente stater, 55102
- Children's Hospitals and Clinics - Minnesota
-
-
Mississippi
-
Jackson, Mississippi, Forente stater, 39216-4505
- University of Mississippi Medical Center
-
-
Missouri
-
Kansas City, Missouri, Forente stater, 64108
- Children's Mercy Hospital
-
Saint Louis, Missouri, Forente stater, 63110
- St. Louis Children's Hospital
-
Saint Louis, Missouri, Forente stater, 63104
- Cardinal Glennon Children's Hospital
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68114
- Children's Hospital of Omaha
-
Omaha, Nebraska, Forente stater, 68198-2168
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89109
- Sunrise Hospital and Medical Center
-
-
New Hampshire
-
Lebanon, New Hampshire, Forente stater, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, Forente stater, 07601
- Cancer Center at Hackensack University Medical Center
-
New Brunswick, New Jersey, Forente stater, 08903
- Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
-
Newark, New Jersey, Forente stater, 07112-2094
- Newark Beth Israel Medical Center
-
Paterson, New Jersey, Forente stater, 07503
- St. Joseph's Hospital and Medical Center
-
Summit, New Jersey, Forente stater, 07901
- Valerie Fund Children's Center at Atlantic Health
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87131
- University of New Mexico Cancer Research and Treatment Center
-
-
New York
-
Albany, New York, Forente stater, 12208
- Cancer Center of Albany Medical Center
-
Bronx, New York, Forente stater, 10461
- Albert Einstein Clinical Cancer Center
-
Brooklyn, New York, Forente stater, 11203
- SUNY Downstate Medical Center
-
Brooklyn, New York, Forente stater, 11212
- Brookdale University Hospital and Medical Center
-
Brooklyn, New York, Forente stater, 11201-5493
- Brooklyn Hospital Center
-
Brooklyn, New York, Forente stater, 11219
- Comprehensive Cancer Center at Maimonides Medical Center
-
Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
-
Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
-
New Hyde Park, New York, Forente stater, 11042
- Schneider Children's Hospital
-
New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forente stater, 10029
- Mount Sinai School of Medicine
-
New York, New York, Forente stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
-
New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
Stony Brook, New York, Forente stater, 11794
- Long Island Cancer Center at Stony Brook University Hospital
-
Syracuse, New York, Forente stater, 13210
- University Hospital at State University of New York - Upstate Medical University
-
Valhalla, New York, Forente stater, 10595
- New York Medical College
-
-
North Carolina
-
Asheville, North Carolina, Forente stater, 28801
- Mission Hospitals
-
Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
Charlotte, North Carolina, Forente stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, Forente stater, 28233
- Presbyterian Healthcare
-
Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
-
Greenville, North Carolina, Forente stater, 27858-4354
- Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
-
Winston-Salem, North Carolina, Forente stater, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
-
Fargo, North Dakota, Forente stater, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
-
-
Ohio
-
Akron, Ohio, Forente stater, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Forente stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forente stater, 44106-5065
- Ireland Cancer Center
-
Columbus, Ohio, Forente stater, 43205-2696
- Children's Hospital of Columbus
-
Dayton, Ohio, Forente stater, 45404
- Children's Medical Center - Dayton
-
Toledo, Ohio, Forente stater, 43601
- Toledo Children's Hospital
-
Toledo, Ohio, Forente stater, 43608
- St. Vincent Mercy Medical Center
-
Youngstown, Ohio, Forente stater, 44501
- Forum Health-Tod Childrens Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- Children's Hospital at Oklahoma University Medical Center
-
Tulsa, Oklahoma, Forente stater, 74136
- Natalie Warren Bryant Cancer Center
-
Tulsa, Oklahoma, Forente stater, 74136
- CCOP - Oklahoma
-
-
Oregon
-
Portland, Oregon, Forente stater, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Forente stater, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
-
Portland, Oregon, Forente stater, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
-
-
Pennsylvania
-
Danville, Pennsylvania, Forente stater, 17822-1320
- Geisinger Medical Center
-
Hershey, Pennsylvania, Forente stater, 17033
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Forente stater, 19134-1095
- St. Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, Forente stater, 15213-2583
- Children's Hospital of Pittsburgh
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
-
Columbia, South Carolina, Forente stater, 29203
- Palmetto Health South Carolina Cancer Center
-
Greenville, South Carolina, Forente stater, 29605
- Children's Hospital of Greenville Hospital System
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57105-1080
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forente stater, 57117-5039
- Sioux Valley Hospital at University of South Dakota Medical Center
-
-
Tennessee
-
Johnson City, Tennessee, Forente stater, 37604
- East Tennessee State University Cancer Center at Johnson City Medical Center
-
Knoxville, Tennessee, Forente stater, 37901
- East Tennessee Children's Hospital
-
Memphis, Tennessee, Forente stater, 38105-2794
- St. Jude Children's Research Hospital
-
Nashville, Tennessee, Forente stater, 37232-6310
- Vanderbilt Children's Hospital
-
-
Texas
-
Amarillo, Texas, Forente stater, 79106
- Texas Tech University Health Sciences Center School of Medicine
-
Austin, Texas, Forente stater, 78701
- Children's Hospital of Austin
-
Dallas, Texas, Forente stater, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, Forente stater, 75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, Forente stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Galveston, Texas, Forente stater, 77555-0361
- University of Texas Medical Branch
-
Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
-
Houston, Texas, Forente stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
Lackland Air Force Base, Texas, Forente stater, 78236
- San Antonio Military Pediatric Cancer and Blood Disorders Center
-
Lubbock, Texas, Forente stater, 79410
- Covenant Children's Hospital
-
San Antonio, Texas, Forente stater, 78207
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Forente stater, 78229-3900
- MBCCOP - South Texas Pediatrics
-
San Antonio, Texas, Forente stater, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
-
Temple, Texas, Forente stater, 76508
- CCOP - Scott and White Hospital
-
Temple, Texas, Forente stater, 76508
- Center for Cancer Prevention and Care at Scott and White Clinic
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute
-
-
Vermont
-
Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center at University of Vermont
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908
- Cancer Center at the University of Virginia
-
Falls Church, Virginia, Forente stater, 22042-3300
- Inova Fairfax Hospital
-
Norfolk, Virginia, Forente stater, 23507
- Children's Hospital of The King's Daughters
-
Portsmouth, Virginia, Forente stater, 23708-5100
- Naval Medical Center, Portsmouth
-
Richmond, Virginia, Forente stater, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
-
Roanoke, Virginia, Forente stater, 24029
- Carilion Medical Center for Children
-
-
Washington
-
Seattle, Washington, Forente stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forente stater, 98112
- Group Health Central Hospital
-
Spokane, Washington, Forente stater, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Forente stater, 98431-5000
- Madigan Army Medical Center
-
Tacoma, Washington, Forente stater, 98415-0299
- Mary Bridge Children's Hospital and Health Center
-
-
West Virginia
-
Charleston, West Virginia, Forente stater, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington, West Virginia, Forente stater, 25701
- Cabell Huntington Hospital
-
Morgantown, West Virginia, Forente stater, 26506-9300
- West Virginia University Hospitals
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forente stater, 54301
- Bellin Memorial Hospital
-
Green Bay, Wisconsin, Forente stater, 54307-9070
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Forente stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Forente stater, 54449-5772
- Marshfield Clinic
-
Marshfield, Wisconsin, Forente stater, 54449
- CCOP - Marshfield Clinic Research Foundation
-
Milwaukee, Wisconsin, Forente stater, 53226
- Midwest Children's Cancer Center
-
-
-
-
-
Groningen, Nederland, 9700 RB
- Academisch Ziekenhuis Groningen
-
-
-
-
-
Auckland, New Zealand
- Starship Children's Hospital
-
-
-
-
-
San Juan, Puerto Rico, 00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
-
Santurce, Puerto Rico, 00912
- San Jorge Childrens Hospital
-
-
-
-
-
Bern, Sveits, CH 3010
- Swiss Pediatric Oncology Group Bern
-
Geneva, Sveits, CH 1211
- Swiss Pediatric Oncology Group Geneva
-
Lausanne, Sveits, CH 1011
- Swiss Pediatric Oncology Group Lausanne
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
SYKDOMENS KARAKTERISTIKA:
Histologisk bekreftet metastatisk stadium IV/klinisk gruppe IV rabdomyosarkom, udifferensiert sarkom eller ektomesenkymom
- Ingen metastaserende embryonale svulster hos pasienter under 10 år, uavhengig av primært sted
- Metastatiske svulster på parameningeale steder er kvalifisert
- Bidimensjonalt målbar sykdom
- Ingen positiv cerebrospinalvæskecytologi eller multiple intrakranielle metastaser
Pasienter med følgende er kun kvalifisert for fortsettelsesbehandling og får kanskje ikke behandling med irinotekan/vinkristin på forhånd:
- Bevis på hodebunnen av hodeskallerosjon eller hodeskallemetastatisk sykdom som fortrenger eller trekker inn duraen, komprimerer hjerneparenkymet eller forårsaker tegn på kranialnerveparese
- Tumor som berører eller forskyver ryggmargen
- Bevis på intrakraniell primær tumorforlengelse
- Svulster som kan forårsake potensielt livstruende komplikasjoner (f.eks. nyre, luftveier) med progresjon på grunn av lokalisering og/eller veksthastighet
- Krever akutt strålebehandling
- Laboratorieverdier stemmer overens med disseminert intravaskulær koagulasjon
PASIENT KARAKTERISTIKA:
Alder:
- Under 50 (alveolært rabdomyosarkom, udifferensiert sarkom og ektomesenkymompasienter)
- 10 til 49 (embryonale histologipasienter)
Ytelsesstatus:
- Ikke spesifisert
Forventet levealder:
- Ikke spesifisert
Hematopoetisk:
- Se Sykdomskarakteristikker
- Absolutt nøytrofiltall større enn 1000/mm^3*
- Blodplateantall større enn 150 000/mm^3* MERK: *Med mindre det er tumorinvolvering i benmargen
Hepatisk:
- Bilirubin mindre enn 1,5 mg/dL
- PT, PTT og fibrinogen mindre enn 1,5 ganger øvre normalgrense
Nyre:
- Kreatinin mindre enn 1,2 mg/dL
Annen:
- Ikke gravid eller ammende
- Fertile pasienter må bruke effektiv prevensjon
FØR SAMTIDIG TERAPI:
Biologisk terapi:
- Ikke spesifisert
Kjemoterapi:
- Ingen tidligere kjemoterapi
Endokrin terapi:
- Tidligere steroider tillatt
Strålebehandling:
- Se Sykdomskarakteristikker
- Ingen tidligere strålebehandling
Kirurgi:
- Ikke mer enn 42 dager siden forrige første kirurgiske prosedyre, inkludert biopsi for diagnose
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Eventfri overlevelse
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Alberto S. Pappo, MD, Texas Children's Cancer Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Soft Tissue Sarcoma Committee of the Children's Oncology Group; Lager JJ, Lyden ER, Anderson JR, Pappo AS, Meyer WH, Breitfeld PP. Pooled analysis of phase II window studies in children with contemporary high-risk metastatic rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2006 Jul 20;24(21):3415-22. doi: 10.1200/JCO.2005.01.9497.
- Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH; Children's Oncology Group. Two consecutive phase II window trials of irinotecan alone or in combination with vincristine for the treatment of metastatic rhabdomyosarcoma: the Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. doi: 10.1200/JCO.2006.07.1720.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer, bindevev og mykt vev
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer, muskelvev
- Myosarkom
- Sarkom
- Rhabdomyosarkom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerasehemmere
- Antibakterielle midler
- Proteinsyntesehemmere
- Antibiotika, antineoplastisk
- Topoisomerase I-hemmere
- Cyklofosfamid
- Irinotekan
- Vincristine
- Sargramostim
- Dactinomycin
Andre studie-ID-numre
- D9802
- COG-D9802 (Annen identifikator: Children's Oncology Group)
- IRS-D9802 (Annen identifikator: Intergroup Rhabdosarcoma Group)
- CCG-D9802 (Annen identifikator: Children's Cancer Group)
- POG-D9802 (Annen identifikator: Pediatric Oncology Group)
- CDR0000067154 (Annen identifikator: Clinical Trials.gov)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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