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Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

24. juli 2014 opdateret af: Children's Oncology Group

Protocol for Patients With Newly Diagnosed Better Risk Acute Lymphoblastic Leukemia (ALL): A POG Pilot Study

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphocytic leukemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES: I. Determine whether a delayed multidrug intensification can be given in conjunction with methotrexate and leucovorin calcium rescue consolidation therapy in children with average risk acute lymphocytic leukemia. II. Determine the feasibility of delivering 6 courses of this therapy in these patients.

OUTLINE: This is a multicenter study. Induction: Patients receive oral dexamethasone twice daily on days 1-29, vincristine IV on days 1, 8, 15, and 22, and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients receive methotrexate intrathecally (IT) on days 1 and 15. CNS 2 and 3 patients also receive methotrexate IT on days 8 and 22. Patients with M1 bone marrow receive oral mercaptopurine daily beginning on day 29. Patients with M2 bone marrow on day 29 receive oral dexamethasone twice daily on days 29-42, vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36, and asparaginase IM on days 29, 32, 36, and 39. Patients with M3 bone marrow on day 29 or M2 or M3 bone marrow on day 43 are taken off study. Consolidation: Patients receive methotrexate IV over 4 hours once a week during weeks 7, 10, 13, 24, 27, and 30, oral leucovorin calcium every 6 hours for 5 doses beginning 42 hours after the start of methotrexate infusion, methotrexate IT during weeks 5, 9, 12, 16, 20, 21, and 29, asparaginase IM 3 times weekly during weeks 16 and 17, and oral mercaptopurine daily during weeks 5-14 and from week 24 until the end of consolidation. Patients receive oral dexamethasone twice daily during weeks 8, 16-18, and 28, vincristine IV on day 1 during weeks 8, 9, 16, 17, 18, 28, and 29, daunorubicin IV on day 1 during weeks 16, 17, and 18, cyclophosphamide IV over 30 minutes on day 1 during week 20, cytarabine IV or subcutaneously on days 2-5 during weeks 20 and 21, and oral thioguanine daily during weeks 20 and 21. Intensive continuation: Patients receive oral methotrexate every 6 hours for 24 hours during weeks 1, 3, 5, and 7, oral mercaptopurine daily, and oral leucovorin calcium every 12 hours for 1 day beginning 48 hours after the start of oral methotrexate. Patients also receive methotrexate IT during week 8, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment repeats every 8 weeks for 6 courses. Another continuation: Patients receive oral methotrexate once weekly except during the week of methotrexate IT administration, oral mercaptopurine daily, methotrexate IT every 8 weeks, vincristine IV on day 1 during week 8, and oral dexamethasone twice daily for 7 days beginning with vincristine. Treatment continues for up to 130 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually for ten years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

59

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital
      • Sainte Foy, Quebec, Canada, GIV 4G2
        • Centre Hospitalier de l'Université Laval
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center
    • California
      • Palo Alto, California, Forenede Stater, 94304
        • Lucile Packard Children's Hospital at Stanford
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Cancer center
      • San Diego, California, Forenede Stater, 92120
        • Kaiser Permanente-Southern California Permanente Medical Group
      • San Diego, California, Forenede Stater, 92134-3202
        • Naval Medical Center - San Diego
      • Santa Clara, California, Forenede Stater, 95051-5386
        • Kaiser Permanente Medical Center - Santa Clara
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Forenede Stater, 33136
        • Sylvester Cancer Center, University of Miami
      • Miami, Florida, Forenede Stater, 33176-2197
        • Baptist Hospital of Miami
      • Orlando, Florida, Forenede Stater, 32803
        • Walt Disney Memorial Cancer Institute
      • West Palm Beach, Florida, Forenede Stater, 33407
        • St. Mary's Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital - Atlanta
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96859-5000
        • Tripler Army Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, Forenede Stater, 60614
        • Children's Memorial Hospital, Chicago
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Christ Hospital
      • Peoria, Illinois, Forenede Stater, 61602
        • Saint Jude Midwest Affiliate
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Regional Medical Center-Saint Francis Campus
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
      • Portland, Maine, Forenede Stater, 04101
        • Maine Children's Cancer Program
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48236
        • St. John's Hospital and Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
      • Keesler AFB, Mississippi, Forenede Stater, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri-Columbia Hospital and Clinics
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Norris Cotton Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • University of New Mexico School of Medicine
    • New York
      • Stony Brook, New York, Forenede Stater, 11790-9832
        • State University of New York Health Sciences Center - Stony Brook
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73126-0307
        • Oklahoma Memorial Hospital
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37614-0622
        • James H. Quillen College of Medicine
    • Texas
      • 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, 77555-1329
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
        • San Antonio Military Pediatric Cancer and Blood Disorders Center
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Clinic
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401-3498
        • Vermont Cancer Center
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22046
        • Inova Fairfax Hospital
      • Roanoke, Virginia, Forenede Stater, 24029
        • Carilion Roanoke Memorial Hospital
    • Washington
      • Tacoma, Washington, Forenede Stater, 98431-5000
        • Madigan Army Medical Center
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • West Virginia University Medical School, Charleston Division
      • Morgantown, West Virginia, Forenede Stater, 26506-9162
        • West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Midwest Children's Cancer Center
  • Holland
      • Groningen, Holland, 9713 EZ
        • Academisch Ziekenhuis Groningen
  • Puerto Rico
      • Santurce, Puerto Rico, 00912
        • San Jorge Childrens Hospital
  • Schweiz
      • Geneva, Schweiz, 1211
        • Clinique de Pediatrie

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 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS: Histologically newly diagnosed early B-cell or B-precursor or B-progenitor acute lymphocytic leukemia Prior registration on POG-9400, stratum 6 for induction therapy Average prognosis (neither very good nor very poor)

PATIENT CHARACTERISTICS: Age: Children Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy other than on POG-9400

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Chemotherapy Treatment
See detailed description.
Medicin: cyclophosphamid
Andre navne:
  • Cytoxan
  • CTX
  • NSC #026271
  • IND #7089
Medicin: leucovorin calcium
Andre navne:
  • LCV
  • Wellcovorin
  • citrovorum faktor
  • folinsyre
  • NSC #003590
Medicin: asparaginase
Andre navne:
  • E coli
  • Elspar
  • NSC #109229
Medicin: cytarabin
Andre navne:
  • Ara-C
  • Cytosar
  • cytosin arabinosid
  • NSC #063878
Medicin: daunorubicin hydrochlorid
Andre navne:
  • Cerubidin
  • daunomycin
  • DNR
  • NSC #82151
Medicin: dexamethason
Andre navne:
  • Dekadron
  • NSC #034521
Medicin: methotrexat
Andre navne:
  • amethopterin
  • MTX
  • NSC #000740
  • IND #4291
Medicin: vincristinsulfat
Andre navne:
  • VCR
  • Oncovin
  • NSC #067574
  • IND #7161
Medicin: mercaptopurin
Andre navne:
  • 6 MP
  • Purinethol
  • NSC #000755
Medicin: thioguanin
Andre navne:
  • 6-thioguanin
  • 6-TG
  • NSC #752

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Event-free survival
Tidsramme: 7 years
7 years

Samarbejdspartnere og efterforskere

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

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Naomi J. Winick, MD, Simmons Cancer Center

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. december 1998

Primær færdiggørelse (Faktiske)

1. november 2002

Studieafslutning (Faktiske)

1. februar 2009

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

10. september 2004

Først opslået (Skøn)

13. september 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 9705
  • POG-9705 (Anden identifikator: Pediatric Oncology Group)
  • CDR0000066768 (Anden identifikator: Clinical Trials.gov)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med cyclophosphamid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner