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Carboxypeptidase-G2 til behandling af toksiske virkninger i nervesystemet hos patienter, der får en overdosis af intrathekal methotrexat

29. april 2015 opdateret af: National Cancer Institute (NCI)

Et forsøg med carboxypeptidase-G2 (CPDG2) til behandling af patienter med intrathekal methotrexat-overdosis

RATIONALE: Kemobeskyttende lægemidler såsom carboxypeptidase-G2 kan beskytte normale celler mod de toksiske virkninger af kemoterapi.

FORMÅL: Klinisk forsøg til undersøgelse af effektiviteten af ​​carboxypeptidase-G2 til behandling af toksiske virkninger på nervesystemet hos patienter, som ved et uheld får en overdosis af intrathekal methotrexat.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

  • Bestem effektiviteten af ​​carboxypeptidase-G2-redning hos patienter, som udvikler livstruende methotrexat (MTX) neurotoksicitet efter utilsigtet intratekal MTX-overdosis.
  • Undersøg CSF-farmakokinetikken af ​​MTX efter redning.

OVERSIGT: Patienter gennemgår en lumbalpunktur så hurtigt som muligt efter methotrexat-overdosis for at fjerne methotrexat og modtager en enkelt dosis carboxypeptidase-G2 intratekalt over 5 minutter.

Patienterne følges i mindst 1 måned.

PROJEKTERET TILSLUTNING: Der vil blive akkumuleret maksimalt 10 patienter til denne undersøgelse.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Westmead, New South Wales, Australien, 2145
        • Westmead Institute for Cancer Research at Westmead Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • 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, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • University of South Alabama Mitchell Cancer Institute
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, Forenede Stater, 90242-2814
        • Southern California Permanente Medical Group
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Madera, California, Forenede Stater, 93638-8762
        • Children's Hospital Central California
      • Orange, California, Forenede Stater, 92868
        • Children's Hospital of Orange County
      • Sacramento, California, Forenede Stater, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Diego, California, Forenede Stater, 92123-4282
        • Children's Hospital and Health Center - San Diego
      • Stanford, California, Forenede Stater, 94305
        • Stanford Comprehensive Cancer Center - Stanford
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19899
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Forenede Stater, 33155
        • Miami Children's Hospital
      • Orlando, Florida, Forenede Stater, 32806
        • Nemours Children's Clinic - Orlando
      • St. Petersburg, Florida, Forenede Stater, 33701
        • All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Winship Cancer Institute of Emory University
      • Savannah, Georgia, Forenede Stater, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 95813
        • Cancer Research Center of Hawaii
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46260
        • St. Vincent Indianapolis Hospital
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, Forenede Stater, 52242-1083
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • CancerCare of Maine at Eastern Maine Medial Center
      • Scarborough, Maine, Forenede Stater, 04074-9308
        • Maine Children's Cancer Program
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0238
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Kalamazoo, Michigan, Forenede Stater, 49007-5341
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota Medical Center & Children's Hospital - Fairview
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Children's Hospitals and Clinics of Minneapolis
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • St. Louis, Missouri, Forenede Stater, 63104
        • Cardinal Glennon Children's Hospital
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114-4113
        • Children's Hospital
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center Cancer Center
      • Morristown, New Jersey, Forenede Stater, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Saint Peter's University Hospital
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Forenede Stater, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, Forenede Stater, 10021-6094
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Forenede Stater, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, Forenede Stater, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195-5217
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forenede Stater, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, Forenede Stater, 45404-1815
        • Children's Medical Center - Dayton
      • Youngstown, Ohio, Forenede Stater, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Cancer Institute
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239-3098
        • Oregon Health & Science University Cancer Institute
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Children's Hospital of Pittsburgh
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Hospital System Cancer Center
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37604
        • East Tennessee State University Cancer Center at Johnson City Medical Center
      • Knoxville, Tennessee, Forenede Stater, 37916
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, Forenede Stater, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, Forenede Stater, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Houston, Texas, Forenede Stater, 77030-2399
        • Baylor University Medical Center - Houston
      • San Antonio, Texas, Forenede Stater, 78229-3993
        • Methodist Children's Hospital of South Texas
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05405
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Cancer Center at UV Health System
      • Fairfax, Virginia, Forenede Stater, 22031
        • Inova Fairfax Hospital
      • Norfolk, Virginia, Forenede Stater, 23507-1971
        • Children's Hospital of The King's Daughters
    • West Virginia
      • Huntington, West Virginia, Forenede Stater, 25701
        • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Midwest Children's Cancer Center
  • Schweiz
      • Geneva, Schweiz, 1205
        • Swiss Pediatric Oncology Group Geneva

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

  • VOKSEN
  • OLDER_ADULT
  • BARN

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SYGDOMS KARAKTERISTIKA:

  • Patienter, der fik en intratekal overdosis af methotrexat på 100 mg eller mere

PATIENT KARAKTERISTIKA:

Alder:

  • Enhver alder

Ydeevnestatus:

  • Ikke specificeret

Hæmatopoietisk:

  • Ikke specificeret

Hepatisk:

  • Ikke specificeret

Nyre:

  • Ikke specificeret

Andet:

  • Ingen forudgående anafylaktisk reaktion på carboxypeptidase-G2 administration

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi

  • Ikke specificeret

Kemoterapi

  • Se Sygdomskarakteristika

Endokrin terapi

  • Ikke specificeret

Strålebehandling

  • Ikke specificeret

Kirurgi

  • Ikke specificeret

Andet

  • Samtidig terapi tilladt

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: SUPPORTIVE_CARE
  • Maskning: INGEN

Samarbejdspartnere og efterforskere

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

Sponsor

National Cancer Institute (NCI)

Samarbejdspartnere

Children's Oncology Group

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. november 1993

Primær færdiggørelse (FAKTISKE)

1. april 2007

Datoer for studieregistrering

Først indsendt

11. juli 2001

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (SKØN)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (SKØN)

30. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2015

Sidst verificeret

1. april 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000077521
  • NCI-92-C-0137N
  • CCG-0923
  • POG-9688
  • NCI-T92-0021N
  • COG-0923
  • COG-P9688

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 .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Togo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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