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Rebeccamycin-analog til behandling af børn med solide tumorer eller non-Hodgkins lymfom

4. februar 2013 opdateret af: National Cancer Institute (NCI)

Et fase II forsøg med Rebeccamycin Analog (NSC #655649) hos børn med solide tumorer

Fase II-forsøg til undersøgelse af effektiviteten af rebeccamycinanalog til behandling af børn, der har solide tumorer eller non-Hodgkins lymfom. Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at stoppe kræftceller i at dele sig, så de holder op med at vokse eller dør.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: becatecarin

Detaljeret beskrivelse

MÅL:

I. Bestem responsen hos børn med solide tumorer eller non-Hodgkins lymfom behandlet med rebeccamycinanalog.

II. Bestem og bibehold en plasmakoncentration på mindst 5 µg/ml af dette lægemiddel hos disse patienter.

III. Bestem toksiciteten af dette lægemiddel hos disse patienter. IV. Bestem farmakokinetikken af dette lægemiddel hos disse patienter.

OVERSIGT: Dette er en multicenterundersøgelse.

Patienter med solide tumorer er stratificeret i henhold til tumorhistologi (neuroblastom vs Ewings sarkom [lukket for akkumulering pr. 19/5/03]/perifer primativ neuroektodermal tumor [PNET] vs osteosarkom [lukket for akkumulering pr. 19/5/03] rhabdomyosarkom vs non-Hodgkins lymfom vs andre solide tumorer). Patienter med CNS-tumorer stratificeres i henhold til tumorhistologi (medulloblastom/PNET vs ependymoma vs hjernestammegliom vs andre CNS-tumorer).

Patienterne får rebeccamycinanalog IV over 1 time på dag 1. Behandlingen fortsætter hver 21. dag i i alt 16 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.

Patienterne følges månedligt i 1 år, hver 2. måned i 2 år, hver 6. måned i 1 år og derefter årligt.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

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, 6006
    - Princess Margaret Hospital for Children
Canada
- Alberta
  - Calgary, Alberta, Canada, T2T 5C7
    - Alberta Children's Hospital
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Vancouver, British Columbia, Canada, V6H 3V4
    - British Columbia Children's Hospital
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - Janeway Children's Health and Rehabilitation Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3J 3G9
    - IWK Health Centre
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Children's Hospital
  - London, Ontario, Canada, N6C 2V5
    - Children's Hospital of Western Ontario
  - Ottawa, Ontario, Canada, K1H 8L1
    - Children's Hospital of Eastern Ontario
  - Toronto, Ontario, Canada, M5G 1X8
    - Hospital for Sick Children
- Quebec
  - Montreal, Quebec, Canada, H3T 1C5
    - Hôpital 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
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35233
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile, Alabama, Forenede Stater, 36604
    - University of South Alabama Medical Center
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85016-7710
    - Phoenix Children's Hospital
  - Tucson, Arizona, Forenede Stater, 85724
    - Arizona Cancer Center
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - University of Arkansas for Medical Sciences
- California
  - Downey, California, Forenede Stater, 90242
    - Southern California Permanente Medical Group
  - Duarte, California, Forenede Stater, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - La Jolla, California, Forenede Stater, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Loma Linda, California, Forenede Stater, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, Forenede Stater, 90801-1428
    - Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  - Los Angeles, California, Forenede Stater, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, Forenede Stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Forenede Stater, 90027-0700
    - Children's Hospital Los Angeles
  - Madera, California, Forenede Stater, 93638-8762
    - Children's Hospital Central California
  - Oakland, California, Forenede Stater, 94609-1809
    - Children's Hospital of Oakland
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center
  - Orange, California, Forenede Stater, 92868
    - Children's Hospital of Orange County
  - Palo Alto, California, Forenede Stater, 94304
    - Lucile Packard Children's Hospital at Stanford
  - Sacramento, California, Forenede Stater, 95816
    - Sutter Cancer Center
  - Sacramento, California, Forenede Stater, 95817
    - University of California Davis Cancer Center
  - San Diego, California, Forenede Stater, 92120
    - Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
  - San Diego, California, Forenede Stater, 92123-4282
    - Children's Hospital San Diego
  - San Francisco, California, Forenede Stater, 94115
    - Kaiser Permanente Medical Center - San Francisco Geary Campus
  - San Francisco, California, Forenede Stater, 94143-0128
    - UCSF Comprehensive Cancer Center
  - Santa Barbara, California, Forenede Stater, 93102
    - Santa Barbara Cottage Hospital
  - Santa Clara, California, Forenede Stater, 95051-5386
    - Kaiser Permanente Medical Center - Santa Clara
  - Travis Air Force Base, California, Forenede Stater, 94535
    - David Grant Medical Center
- Colorado
  - Denver, Colorado, Forenede Stater, 80218
    - Presbyterian-St Luke's Medical Center
  - Denver, Colorado, Forenede Stater, 80218
    - Children's Hospital of Denver
- Connecticut
  - Farmington, Connecticut, Forenede Stater, 06360-7106
    - University of Connecticut Health Center
  - New Haven, Connecticut, Forenede Stater, 06520-8028
    - Yale Comprehensive Cancer Center
- Delaware
  - Wilmington, Delaware, Forenede Stater, 19899
    - Alfred I. Dupont Institute
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20307-5000
    - Walter Reed Army Medical Center
  - Washington, District of Columbia, Forenede Stater, 20010-2970
    - Children's National Medical Center
  - Washington, District of Columbia, Forenede Stater, 20007
    - Lombardi Cancer Center
- Florida
  - Fort Lauderdale, Florida, Forenede Stater, 33316
    - Broward General Medical Center
  - Fort Myers, Florida, Forenede Stater, 33908
    - Children's Hospital of Southwest Florida
  - Gainesville, Florida, Forenede Stater, 32610-100277
    - Shands Hospital and Clinics, University of Florida
  - Hollywood, Florida, Forenede Stater, 33021
    - Joe DiMaggio Children's Hospital at Memorial
  - Jacksonville, Florida, Forenede Stater, 32207
    - Nemours Children's Clinic
  - Miami, Florida, Forenede Stater, 33176-2197
    - Baptist Hospital of Miami
  - Miami, Florida, Forenede Stater, 33136
    - University of Miami-Jackson Memorial Hospital
  - Miami, Florida, Forenede Stater, 33155-4069
    - Miami Children's Hospital
  - Orlando, Florida, Forenede Stater, 32806
    - Nemours Children's Clinic-Orlando
  - Orlando, Florida, Forenede Stater, 32803
    - Walt Disney Memorial Cancer Institute at Florida Hospital
  - Pensacola, Florida, Forenede Stater, 32504
    - Sacred Heart Children's Hospital
  - St. Petersburg, Florida, Forenede Stater, 33701
    - All Children's Hospital
  - Tampa, Florida, Forenede Stater, 33677-4227
    - Tampa Children's Hospital
  - West Palm Beach, Florida, Forenede Stater, 33407
    - St. Mary's Hospital
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Emory University Hospital - Atlanta
  - Atlanta, Georgia, Forenede Stater, 30342
    - Children's Healthcare of Atlanta - Scottish Rite
  - Augusta, Georgia, Forenede Stater, 30912-4000
    - Medical College of Georgia Comprehensive Cancer Center
  - Macon, Georgia, Forenede Stater, 31201
    - Medical Center of Central Georgia
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96859-5000
    - Tripler Army Medical Center
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Cancer Research Center of Hawaii
- Idaho
  - Boise, Idaho, Forenede Stater, 83712
    - Mountain States Tumor Institute
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612
    - University of Illinois at Chicago
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush-Presbyterian-St. Luke's Medical Center
  - Chicago, Illinois, Forenede Stater, 60614
    - Children's Memorial Hospital - Chicago
  - Chicago, Illinois, Forenede Stater, 60601
    - University of Chicago Cancer Research Center
  - Oak Lawn, Illinois, Forenede Stater, 60453
    - Advocate Hope Children's Hospital
  - Park Ridge, Illinois, Forenede Stater, 60068-1174
    - Lutheran General Hospital
  - Peoria, Illinois, Forenede Stater, 61637
    - Saint Jude Midwest Affiliate
  - Springfield, Illinois, Forenede Stater, 62794-9658
    - Southern Illinois University School of Medicine
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202-5289
    - Indiana University Cancer Center
  - Indianapolis, Indiana, Forenede Stater, 46260
    - St. Vincent Hospital and Health Care Center
- Iowa
  - Des Moines, Iowa, Forenede Stater, 50308
    - Raymond Blank Memorial Hospital for Children
  - Iowa City, Iowa, Forenede Stater, 52242-1009
    - Holden Comprehensive Cancer Center
- Kansas
  - Wichita, Kansas, Forenede Stater, 67214
    - Wesley Medical Center
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40536-0284
    - Albert B. Chandler Medical Center, University of Kentucky
  - Louisville, Kentucky, Forenede Stater, 40202-3830
    - Kosair Children's Hospital
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70121
    - Ochsner Clinic Foundation
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, Forenede Stater, 70118
    - Children's Hospital of New Orleans
- 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, 21201-1595
    - Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  - Baltimore, Maryland, Forenede Stater, 21225
    - Sinai Hospital of Baltimore
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, Forenede Stater, 02111
    - Floating Hospital for Children
  - Springfield, Massachusetts, Forenede Stater, 01107
    - Baystate Medical Center
  - Worcester, Massachusetts, Forenede Stater, 01655
    - University of Massachusetts Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109-0752
    - University Of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, Forenede Stater, 48201
    - Children's Hospital of Michigan
  - Detroit, Michigan, Forenede Stater, 48236
    - St. John Hospital and Medical Center
  - East Lansing, Michigan, Forenede Stater, 48824
    - Michigan State University
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Spectrum Health and DeVos Children's Hospital
  - Kalamazoo, Michigan, Forenede Stater, 49007
    - Bronson Methodist Hospital
  - Royal Oak, Michigan, Forenede Stater, 48073-6769
    - William Beaumont Hospital
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55805-1983
    - St. Mary's/Duluth Clinic Cancer Center
  - Minneapolis, Minnesota, Forenede Stater, 55404
    - Children's Hospitals and Clinics - Minneapolis
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Paul, Minnesota, Forenede Stater, 55102
    - Children's Hospitals and Clinics - Minnesota
- Mississippi
  - Jackson, Mississippi, Forenede Stater, 39216-4505
    - University of Mississippi Medical Center
- Missouri
  - Columbia, Missouri, Forenede Stater, 65212
    - University of Missouri-Columbia Hospital and Clinics
  - Kansas City, Missouri, Forenede Stater, 64108
    - Children's Mercy Hospital
  - Saint Louis, Missouri, Forenede Stater, 63110
    - St. Louis Children's Hospital
  - Saint Louis, Missouri, Forenede Stater, 63104
    - Cardinal Glennon Children's Hospital
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68114
    - Children's Hospital of Omaha
  - Omaha, Nebraska, Forenede Stater, 68198-2168
    - University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89109-2306
    - Sunrise Hospital and Medical Center
- New Hampshire
  - Lebanon, New Hampshire, Forenede Stater, 03756-0002
    - Norris Cotton Cancer Center
- New Jersey
  - Hackensack, New Jersey, Forenede Stater, 07601
    - Hackensack University Medical Center
  - Livingston, New Jersey, Forenede Stater, 07039
    - St. Barnabas Medical Center
  - New Brunswick, New Jersey, Forenede Stater, 08903
    - Cancer Institute Of New Jersey
  - Newark, New Jersey, Forenede Stater, 07112-2094
    - Newark Beth Israel Medical Center
  - Paterson, New Jersey, Forenede Stater, 07503
    - St. Joseph's Hospital and Medical Center
  - Summit, New Jersey, Forenede Stater, 07901
    - Atlantic Health System
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87131
    - University of New Mexico Cancer Research and Treatment Center
- New York
  - Albany, New York, Forenede Stater, 12208
    - Cancer Center of Albany Medical Center
  - Bronx, New York, Forenede Stater, 10461
    - Albert Einstein Clinical Cancer Center
  - Brooklyn, New York, Forenede Stater, 11219
    - Maimonides Medical Center
  - Brooklyn, New York, Forenede Stater, 11201
    - Brooklyn Hospital Center
  - Brooklyn, New York, Forenede Stater, 11203
    - State University of New York Health Science Center at Brooklyn College of Medicine
  - Brooklyn, New York, Forenede Stater, 11212
    - Brookdale University Hospital and Medical Center
  - Buffalo, New York, Forenede Stater, 14263-0001
    - Roswell Park Cancer Institute
  - Manhasset, New York, Forenede Stater, 11030
    - North Shore University Hospital
  - New Hyde Park, New York, Forenede Stater, 11042
    - Schneider Children's Hospital
  - New York, New York, Forenede Stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, Forenede Stater, 10029
    - Mount Sinai School of Medicine
  - New York, New York, Forenede Stater, 10032
    - Herbert Irving Comprehensive Cancer Center
  - New York, New York, Forenede Stater, 10021-4885
    - New York Presbyterian Hospital - Cornell Campus
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center
  - Stony Brook, New York, Forenede Stater, 11790-7775
    - State University of New York Health Sciences Center - Stony Brook
  - Syracuse, New York, Forenede Stater, 13210
    - State University of New York - Upstate Medical University
  - Valhalla, New York, Forenede Stater, 10595
    - New York Medical College
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28801
    - Mission St. Joseph's Health System
  - Chapel Hill, North Carolina, Forenede Stater, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Charlotte, North Carolina, Forenede Stater, 28232-2861
    - Carolinas Medical Center
  - Charlotte, North Carolina, Forenede Stater, 28233
    - Presbyterian Healthcare
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke Comprehensive Cancer Center
  - Greenville, North Carolina, Forenede Stater, 27858-4354
    - East Carolina University School of Medicine
- North Dakota
  - Fargo, North Dakota, Forenede Stater, 58103-4940
    - Dakota Cancer Institute
- Ohio
  - Akron, Ohio, Forenede Stater, 44308
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, Forenede Stater, 45229-3039
    - Children's Hospital Medical Center - Cincinnati
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Forenede Stater, 44106-5065
    - Ireland Cancer Center
  - Columbus, Ohio, Forenede Stater, 43205-2696
    - Children's Hospital of Columbus
  - Dayton, Ohio, Forenede Stater, 45404
    - Children's Medical Center - Dayton
  - Toledo, Ohio, Forenede Stater, 43601
    - Toledo Children's Hospital
  - Youngstown, Ohio, Forenede Stater, 44501
    - Forum Health-Tod Childrens Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Children's Hospital of Oklahoma
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - Natalie Warren Bryant Cancer Center
- Oregon
  - Portland, Oregon, Forenede Stater, 97201-3098
    - Doernbecher Children's Hospital
  - Portland, Oregon, Forenede Stater, 97227
    - Legacy Emanuel Hospital and Health Center
- Pennsylvania
  - Danville, Pennsylvania, Forenede Stater, 17822-1320
    - Geisinger Medical Center
  - Hershey, Pennsylvania, Forenede Stater, 17033-0850
    - Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Children's Hospital of Philadelphia
  - Philadelphia, Pennsylvania, Forenede Stater, 19134-1095
    - St. Christopher's Hospital for Children
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - Children's Hospital of Pittsburgh
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425-0721
    - Medical University of South Carolina
  - Columbia, South Carolina, Forenede Stater, 29203
    - Palmetto Health South Carolina Cancer Center
  - Greenville, South Carolina, Forenede Stater, 29605
    - Children's Hospital of Greenville Hospital System
- South Dakota
  - Sioux Falls, South Dakota, Forenede Stater, 57105-1080
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Forenede Stater, 57117
    - Sioux Valley Hospital
- Tennessee
  - Johnson City, Tennessee, Forenede Stater, 37604
    - East Tennessee State University Cancer Center at JCMC
  - Knoxville, Tennessee, Forenede Stater, 37901
    - East Tennessee Children's Hospital
  - Memphis, Tennessee, Forenede Stater, 38105-2794
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Forenede Stater, 37232-6838
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Texas Tech University Health Sciences Center School of Medicine
  - Dallas, Texas, Forenede Stater, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, Forenede Stater, 75235-9154
    - Simmons Cancer Center - Dallas
  - Fort Worth, Texas, Forenede Stater, 76104
    - Cook Children's Medical Center - Fort Worth
  - Galveston, Texas, Forenede Stater, 77555-0361
    - University of Texas Medical Branch
  - Houston, Texas, Forenede Stater, 77030
    - Baylor College of Medicine
  - Houston, Texas, Forenede Stater, 77030-4009
    - University of Texas - MD Anderson Cancer Center
  - Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
    - San Antonio Military Pediatric Cancer and Blood Disorders Center
  - Lubbock, Texas, Forenede Stater, 79410
    - Covenant Children's Hospital
  - San Antonio, Texas, Forenede Stater, 78207
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Forenede Stater, 78229-3902
    - Methodist Health Care System
  - Temple, Texas, Forenede Stater, 76508
    - Scott and White Memorial Hospital
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84112
    - Huntsman Cancer Institute
- Vermont
  - Burlington, Vermont, Forenede Stater, 05401-3498
    - Vermont Cancer Center
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22908
    - Cancer Center at the University of Virginia
  - Falls Church, Virginia, Forenede Stater, 22042-3300
    - INOVA Fairfax Hospital
  - Norfolk, Virginia, Forenede Stater, 23507
    - Children's Hospital of The King's Daughters
  - Portsmouth, Virginia, Forenede Stater, 23708-5100
    - Naval Medical Center, Portsmouth
  - Richmond, Virginia, Forenede Stater, 23298-0037
    - Massey Cancer Center
  - Roanoke, Virginia, Forenede Stater, 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 Cooperative
  - Spokane, Washington, Forenede Stater, 99210-0248
    - Deaconess Medical Center
  - Tacoma, Washington, Forenede Stater, 98431-5000
    - Madigan Army Medical Center
- West Virginia
  - Charleston, West Virginia, Forenede Stater, 25302
    - West Virginia University - Charleston
  - Huntington, West Virginia, Forenede Stater, 25701
    - Cabell-Huntington Hospital, Inc
  - Morgantown, West Virginia, Forenede Stater, 26506-9300
    - West Virginia University Hospitals
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54301
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay
  - Green Bay, Wisconsin, Forenede Stater, 54301
    - Bellin Memorial Hospital
  - Green Bay, Wisconsin, Forenede Stater, 54307-9070
    - St. Vincent Hospital
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Forenede Stater, 53792-6164
    - University of Wisconsin Comprehensive Cancer Center
  - Madison, Wisconsin, Forenede Stater, 53792-6164
    - Medical College of Ohio Hospital
  - Marshfield, Wisconsin, Forenede Stater, 54449-5772
    - Marshfield Clinic
  - Milwaukee, Wisconsin, Forenede Stater, 53226
    - Midwest Children's Cancer Center
Holland
- - Groningen, Holland, 9700 RB
    - Academisch Ziekenhuis Groningen
New Zealand
- - Auckland, New Zealand
    - Starship Children's Hospital
Puerto Rico
- - San Juan, Puerto Rico, 00936-5067
    - University of Puerto Rico School of Medicine Medical Sciences Campus
  - Santurce, Puerto Rico, 00912
    - San Jorge Childrens Hospital
Schweiz
- - Bern, Schweiz, CH 3010
    - Swiss Pediatric Oncology Group Bern
  - Geneva, Schweiz, CH 1211
    - Swiss Pediatric Oncology Group Geneva
  - Lausanne, Schweiz, CH 1011
    - Swiss Pediatric Oncology Group Lausanne

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 21 år (VOKSEN, BARN)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

Histologisk eller cytologisk bekræftede solide tumorer
- Neuroblastom
- Ewings sarkom/perifer primitiv neuroektodermal tumor (PNET) (Ewings sarkom lukket for optjening pr. 19/5/03)
- Osteosarkom (lukket for optjening pr. 19/5/03)
- Rhabdomyosarkom
- Andre ekstrakranielle solide tumorer
- CNS/hjernetumorer:
  - Medulloblastom/PNET
  - Ependymom
  - Hjernestamgliom
  - Andre CNS-tumorer
- Histologisk verifikation kan fraviges for hjernestammegliom og klassisk optisk gliom, men biopsi anbefales ELLER
Histologisk eller cytologisk bevist non-Hodgkins lymfom
- Refraktær over for standardbehandling og ingen helbredende terapi tilgængelig
Målbar sygdom

PATIENT KARAKTERISTIKA:

Alder:

21 og derunder på tidspunktet for den oprindelige diagnose

Ydeevnestatus:

Karnofsky 50-100% hos patienter over 10 år
Lansky 50-100 % hos patienter på 10 år og derunder

Forventede levealder:

Mindst 8 uger

Hæmatopoietisk:

Absolut neutrofiltal større end 1.000/mm^3
Blodpladetal større end 75.000/mm^3
Hæmoglobin større end 8,0 g/dL

Hepatisk:

Bilirubin normalt for alder
SGPT mindre end 2,5 gange øvre normalgrænse
Amylase normal
Lipase normal

Nyre:

Kreatinin normalt for alder ELLER
Glomerulær filtrationshastighed mindst 60 ml/min

Andet:

Ingen samtidig ukontrolleret infektion
Ikke gravid eller ammende
Negativ graviditetstest
Fertile patienter skal anvende effektiv prævention under og i 6 måneder efter deltagelse i undersøgelsen

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

Kom sig efter tidligere immunterapi

Kemoterapi:

Mindst 6 uger siden tidligere nitrosourea og restitueret
Kom sig efter enhver anden tidligere kemoterapi
Ikke mere end to tidligere kemoterapiregimer

Endokrin terapi:

CNS-tumorpatienter, der får dexamethason, skal have en stabil eller faldende dosis mindst 2 uger før studiestart

Strålebehandling:

Mindst 6 uger siden tidligere forlænget strålebehandling og kommet sig
Ingen forudgående bestråling af hele kroppen

Kirurgi:

Forudgående strålekirurgi tilladt

Andet:

Ingen samtidig brug af følgende fødevarer eller medicin:
- Grapefrugtjuice
- Erythromycin
- Azithromycin
- Clarithromycin
- Rifampin og analoger
- Fluconazol
- Ketoconazol
- Itraconazol
- Cimetidin
- Cannabinoider (marihuana eller dronabinol)
- Leukotrienhæmmere (fx zafirlukast og zileuton)
Ingen andre samtidige anticancer- eller undersøgelsesmidler

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: BEHANDLING
Tildeling: NA
Interventionel model: SINGLE_GROUP
Maskning: INGEN

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
EKSPERIMENTEL: Arm I Patienter med solide tumorer er stratificeret i henhold til tumorhistologi (neuroblastom vs Ewings sarkom [lukket for akkumulering pr. 19/5/03]/perifer primativ neuroektodermal tumor [PNET] vs osteosarkom [lukket for akkumulering pr. 19/5/03] rhabdomyosarkom vs non-Hodgkins lymfom vs andre solide tumorer). Patienter med CNS-tumorer stratificeres i henhold til tumorhistologi (medulloblastom/PNET vs ependymoma vs hjernestammegliom vs andre CNS-tumorer). Patienterne får rebeccamycinanalog IV over 1 time på dag 1. Behandlingen fortsætter hver 21. dag i i alt 16 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.	Medicin: becatecarin

Deltagergruppe / Arm

Intervention / Behandling

EKSPERIMENTEL: Arm I

Patienterne får rebeccamycinanalog IV over 1 time på dag 1. Behandlingen fortsætter hver 21. dag i i alt 16 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.

Medicin: becatecarin

Samarbejdspartnere og efterforskere

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

Sponsor

National Cancer Institute (NCI)

Efterforskere

Studiestol: Anne-Marie Langevin, MD, The University of Texas Health Science Center at San Antonio

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

Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC; Children's Oncology Group. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Mar;50(3):577-80. doi: 10.1002/pbc.21274.

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. juli 2000

Primær færdiggørelse (FAKTISKE)

1. juni 2006

Datoer for studieregistrering

Først indsendt

3. august 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (SKØN)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (SKØN)

5. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. februar 2013

Sidst verificeret

1. november 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCI-2012-01851
COG-P9963
CDR0000068111 (REGISTRERING: PDQ (Physician Data Query))

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 .