- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00006102
Rebeccamycin-analog ved behandling av barn med solide svulster eller non-Hodgkins lymfom
En fase II-studie av Rebeccamycin Analog (NSC #655649) hos barn med solide svulster
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
MÅL:
I. Bestem responsen hos barn med solide svulster eller non-Hodgkins lymfom behandlet med rebeccamycinanalog.
II. Bestem og oppretthold en plasmakonsentrasjon på minst 5 µg/ml av dette legemidlet hos disse pasientene.
III. Bestem toksisiteten til dette stoffet hos disse pasientene. IV. Bestem farmakokinetikken til dette legemidlet hos disse pasientene.
OVERSIKT: Dette er en multisenterstudie.
Pasienter med solide svulster er stratifisert i henhold til tumorhistologi (neuroblastom vs Ewings sarkom [stengt for akkumulering per 19.5.03]/perifer primativ nevroektodermal svulst [PNET] vs osteosarkom [stengt for akkumulering pr. 19.5.03] rabdomyosarkom vs non-Hodgkins lymfom vs andre solide svulster). Pasienter med CNS-svulster er stratifisert i henhold til tumorhistologi (medulloblastom/PNET vs ependymoma vs hjernestammegliom vs andre CNS-svulster).
Pasienter får rebeccamycinanalog IV over 1 time på dag 1. Behandlingen fortsetter hver 21. dag i totalt 16 kurer i fravær av sykdomsprogresjon eller uakseptabel toksisitet.
Pasientene følges månedlig i 1 år, hver 2. måned i 2 år, hver 6. måned i 1 år, og deretter årlig.
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, 6006
- 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
- 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, G1V 4G2
- Laval University Medical Center
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
-
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 Medical Center
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85016-7710
- Phoenix Children's Hospital
-
Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72205
- 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 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 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 of Oakland
-
Orange, California, Forente stater, 92868
- Chao Family Comprehensive Cancer Center
-
Orange, California, Forente stater, 92868
- Children's Hospital of Orange County
-
Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford
-
Sacramento, California, Forente stater, 95816
- Sutter Cancer Center
-
Sacramento, California, Forente stater, 95817
- University of California Davis Cancer Center
-
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 San Diego
-
San Francisco, California, Forente stater, 94115
- Kaiser Permanente Medical Center - San Francisco Geary Campus
-
San Francisco, California, Forente stater, 94143-0128
- 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
- Presbyterian-St Luke's Medical Center
-
Denver, Colorado, Forente stater, 80218
- Children's Hospital of Denver
-
-
Connecticut
-
Farmington, Connecticut, Forente stater, 06360-7106
- 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 Institute
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20307-5000
- Walter Reed Army Medical Center
-
Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical Center
-
Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer 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, 32610-100277
- Shands Hospital and Clinics, University of Florida
-
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, 33136
- University of Miami-Jackson Memorial Hospital
-
Miami, Florida, Forente stater, 33155-4069
- Miami Children's Hospital
-
Orlando, Florida, Forente stater, 32806
- Nemours Children's Clinic-Orlando
-
Orlando, Florida, Forente stater, 32803
- Walt Disney Memorial Cancer Institute at Florida Hospital
-
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
- Tampa Children's Hospital
-
West Palm Beach, Florida, Forente stater, 33407
- St. Mary's Hospital
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital - Atlanta
-
Atlanta, Georgia, Forente stater, 30342
- Children's Healthcare of Atlanta - Scottish Rite
-
Augusta, Georgia, Forente stater, 30912-4000
- Medical College of Georgia Comprehensive Cancer Center
-
Macon, Georgia, Forente stater, 31201
- Medical Center of Central Georgia
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96859-5000
- Tripler Army Medical Center
-
Honolulu, Hawaii, Forente stater, 96813
- Cancer Research Center of Hawaii
-
-
Idaho
-
Boise, Idaho, Forente stater, 83712
- Mountain States Tumor Institute
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60612
- University of Illinois at Chicago
-
Chicago, Illinois, Forente stater, 60612
- Rush-Presbyterian-St. Luke's Medical Center
-
Chicago, Illinois, Forente stater, 60614
- Children's Memorial Hospital - Chicago
-
Chicago, Illinois, Forente stater, 60601
- University of Chicago Cancer Research Center
-
Oak Lawn, Illinois, Forente stater, 60453
- Advocate Hope Children's Hospital
-
Park Ridge, Illinois, Forente stater, 60068-1174
- Lutheran General Hospital
-
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, 46202-5289
- Indiana University Cancer Center
-
Indianapolis, Indiana, Forente stater, 46260
- St. Vincent Hospital and Health Care Center
-
-
Iowa
-
Des Moines, Iowa, Forente stater, 50308
- Raymond Blank Memorial Hospital for Children
-
Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67214
- Wesley Medical Center
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40536-0284
- Albert B. Chandler Medical Center, University of Kentucky
-
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, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, Forente stater, 70118
- Children's Hospital of New Orleans
-
-
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, 21201-1595
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
-
Baltimore, Maryland, Forente stater, 21225
- Sinai Hospital of Baltimore
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forente stater, 02111
- Floating Hospital for Children
-
Springfield, Massachusetts, Forente stater, 01107
- Baystate Medical Center
-
Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Memorial Medical Center - University Campus
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
-
Detroit, Michigan, Forente stater, 48236
- St. John Hospital and Medical Center
-
East Lansing, Michigan, Forente stater, 48824
- Michigan State University
-
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
- Bronson Methodist Hospital
-
Royal Oak, Michigan, Forente stater, 48073-6769
- William Beaumont Hospital
-
-
Minnesota
-
Duluth, Minnesota, Forente stater, 55805-1983
- 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
-
Columbia, Missouri, Forente stater, 65212
- University of Missouri-Columbia Hospital and Clinics
-
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
- University of Nebraska Medical Center
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89109-2306
- Sunrise Hospital and Medical Center
-
-
New Hampshire
-
Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center
-
-
New Jersey
-
Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center
-
Livingston, New Jersey, Forente stater, 07039
- St. Barnabas Medical Center
-
New Brunswick, New Jersey, Forente stater, 08903
- Cancer Institute Of New Jersey
-
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
- Atlantic Health System
-
-
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, 11219
- Maimonides Medical Center
-
Brooklyn, New York, Forente stater, 11201
- Brooklyn Hospital Center
-
Brooklyn, New York, Forente stater, 11203
- State University of New York Health Science Center at Brooklyn College of Medicine
-
Brooklyn, New York, Forente stater, 11212
- Brookdale University Hospital and 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, 10032
- Herbert Irving Comprehensive Cancer Center
-
New York, New York, Forente stater, 10021-4885
- New York Presbyterian Hospital - Cornell Campus
-
Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center
-
Stony Brook, New York, Forente stater, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
-
Syracuse, New York, Forente stater, 13210
- 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 St. Joseph's Health System
-
Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Charlotte, North Carolina, Forente stater, 28232-2861
- 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
- East Carolina University School of Medicine
-
-
North Dakota
-
Fargo, North Dakota, Forente stater, 58103-4940
- Dakota Cancer Institute
-
-
Ohio
-
Akron, Ohio, Forente stater, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, Forente stater, 45229-3039
- Children's Hospital Medical Center - Cincinnati
-
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
-
Youngstown, Ohio, Forente stater, 44501
- Forum Health-Tod Childrens Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- Children's Hospital of Oklahoma
-
Tulsa, Oklahoma, Forente stater, 74136
- Natalie Warren Bryant Cancer Center
-
-
Oregon
-
Portland, Oregon, Forente stater, 97201-3098
- Doernbecher Children's Hospital
-
Portland, Oregon, Forente stater, 97227
- Legacy Emanuel Hospital and Health Center
-
-
Pennsylvania
-
Danville, Pennsylvania, Forente stater, 17822-1320
- Geisinger Medical Center
-
Hershey, Pennsylvania, Forente stater, 17033-0850
- 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
- Children's Hospital of Pittsburgh
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425-0721
- 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
- Sioux Valley Hospital
-
-
Tennessee
-
Johnson City, Tennessee, Forente stater, 37604
- East Tennessee State University Cancer Center at JCMC
-
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, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Texas
-
Amarillo, Texas, Forente stater, 79106
- Texas Tech University Health Sciences Center School of Medicine
-
Dallas, Texas, Forente stater, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, Forente stater, 75235-9154
- Simmons Cancer 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, 78236-5300
- 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, 78229-3902
- Methodist Health Care System
-
Temple, Texas, Forente stater, 76508
- Scott and White Memorial Hospital
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute
-
-
Vermont
-
Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center
-
-
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, 23298-0037
- Massey Cancer Center
-
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 Cooperative
-
Spokane, Washington, Forente stater, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Forente stater, 98431-5000
- Madigan Army Medical Center
-
-
West Virginia
-
Charleston, West Virginia, Forente stater, 25302
- West Virginia University - Charleston
-
Huntington, West Virginia, Forente stater, 25701
- Cabell-Huntington Hospital, Inc
-
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 Medical Center
-
Madison, Wisconsin, Forente stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
-
Madison, Wisconsin, Forente stater, 53792-6164
- Medical College of Ohio Hospital
-
Marshfield, Wisconsin, Forente stater, 54449-5772
- Marshfield Clinic
-
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
- University of Puerto Rico School of Medicine 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 eller cytologisk bekreftet solide svulster
- Nevroblastom
- Ewings sarkom/perifer primitiv nevroektodermal svulst (PNET) (Ewings sarkom stengt for påløp fra 19.5.03)
- Osteosarkom (stengt for opptjening fra 19.05.03)
- Rhabdomyosarkom
- Andre ekstrakranielle solide svulster
CNS/hjernesvulster:
- Medulloblastom/PNET
- Ependymom
- Hjernestammen gliom
- Andre CNS-svulster
- Histologisk verifisering kan fravikes for hjernestammegliom og klassisk optisk gliom, men biopsi anbefales ELLER
Histologisk eller cytologisk bevist non-Hodgkins lymfom
- Refraktær mot standardbehandling og ingen kurativ terapi tilgjengelig
- Målbar sykdom
PASIENT EGENSKAPER:
Alder:
- 21 og yngre ved opprinnelig diagnose
Ytelsesstatus:
- Karnofsky 50-100 % hos pasienter over 10 år
- Lansky 50-100 % hos pasienter i alderen 10 år og under
Forventet levealder:
- Minst 8 uker
Hematopoetisk:
- Absolutt nøytrofiltall større enn 1000/mm^3
- Blodplateantall større enn 75 000/mm^3
- Hemoglobin større enn 8,0 g/dL
Hepatisk:
- Bilirubin normalt for alder
- SGPT mindre enn 2,5 ganger øvre normalgrense
- Amylase normal
- Lipase normal
Nyre:
- Kreatinin normalt for alder ELLER
- Glomerulær filtrasjonshastighet minst 60 ml/min
Annen:
- Ingen samtidig ukontrollert infeksjon
- Ikke gravid eller ammende
- Negativ graviditetstest
- Fertile pasienter må bruke effektiv prevensjon under og i 6 måneder etter studiedeltakelse
FØR SAMTIDIG TERAPI:
Biologisk terapi:
- Gjenopprettet fra tidligere immunterapi
Kjemoterapi:
- Minst 6 uker siden tidligere nitrosourea og restituert
- Kommet seg etter annen tidligere kjemoterapi
- Ikke mer enn to tidligere kjemoterapiregimer
Endokrin terapi:
- CNS-svulstpasienter som får deksametason må ha stabil eller avtagende dose minst 2 uker før studiestart
Strålebehandling:
- Minst 6 uker siden tidligere utvidet strålebehandling og ble frisk
- Ingen tidligere bestråling av hele kroppen
Kirurgi:
- Tidligere radiokirurgi tillatt
Annen:
Ingen samtidig bruk av følgende matvarer eller medisiner:
- Grapefrukt juice
- Erytromycin
- Azitromycin
- Klaritromycin
- Rifampin og analoger
- Flukonazol
- Ketokonazol
- Itrakonazol
- Cimetidin
- Cannabinoider (marihuana eller dronabinol)
- Leukotrienhemmere (f.eks. zafirlukast og zileuton)
- Ingen andre samtidige kreft- eller undersøkelsesmidler
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: BEHANDLING
- Tildeling: NA
- Intervensjonsmodell: SINGLE_GROUP
- Masking: INGEN
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
EKSPERIMENTELL: Arm I
Pasienter med solide svulster er stratifisert i henhold til tumorhistologi (neuroblastom vs Ewings sarkom [stengt for akkumulering per 19.5.03]/perifer primativ nevroektodermal svulst [PNET] vs osteosarkom [stengt for akkumulering pr. 19.5.03] rabdomyosarkom vs non-Hodgkins lymfom vs andre solide svulster). Pasienter med CNS-svulster er stratifisert i henhold til tumorhistologi (medulloblastom/PNET vs ependymoma vs hjernestammegliom vs andre CNS-svulster). Pasienter får rebeccamycinanalog IV over 1 time på dag 1. Behandlingen fortsetter hver 21. dag i totalt 16 kurer i fravær av sykdomsprogresjon eller uakseptabel toksisitet. |
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Anne-Marie Langevin, MD, The University of Texas Health Science Center at San Antonio
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (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
- uspesifisert solid barndomssvulst, protokollspesifikk
- høygradig cerebralt astrocytom i barndommen
- stadium IV barndom små non-cleaved cell lymfom
- stadium IV storcellet lymfom i barndommen
- tilbakevendende små ikke-spaltede celle lymfomer i barndommen
- tilbakevendende storcellet lymfom i barndommen
- tidligere behandlet rabdomyosarkom i barndommen
- tilbakevendende rabdomyosarkom i barndommen
- spredt nevroblastom
- tilbakevendende nevroblastom
- stadium III storcellet lymfom i barndommen
- stadium III barndoms lymfoblastisk lymfom
- stadium IV barndoms lymfoblastisk lymfom
- infratentorielt ependymom i barndommen
- tilbakevendende lymfoblastisk lymfom i barndommen
- barndom supratentorial ependymom
- oligodendrogliom i barndommen
- tilbakevendende supratentorial primitiv nevroektodermal svulst i barndommen
- tilbakevendende cerebellar astrocytom i barndommen
- tilbakevendende cerebralt astrocytom i barndommen
- tilbakevendende barndomsependymom
- tilbakevendende hjernestammegliom i barndommen
- tilbakevendende medulloblastom i barndommen
- tilbakevendende barndomssynsvei og hypotalamisk gliom
- barndoms kraniofaryngiom
- barndoms svulst i sentralnervesystemet
- barndom choroid plexus tumor
- meningeom i barndomsklasse I
- meningeom i barndom grad II
- meningeom i barndom grad III
- intraokulært retinoblastom
- ekstraokulært retinoblastom
- tilbakevendende retinoblastom
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Øyesykdommer
- Retinale sykdommer
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Øyesykdommer, arvelig
- Neuroektodermale svulster, primitive
- Neuroektodermale svulster, primitive, perifere
- Øye neoplasmer
- Netthinneneoplasmer
- Neoplasmer
- Lymfom
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Nevroblastom
- Retinoblastom
Andre studie-ID-numre
- NCI-2012-01851
- COG-P9963
- CDR0000068111 (REGISTER: PDQ (Physician Data Query))
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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