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Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia

24. juli 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

59

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Chemotherapy Treatment
See detailed description.
Legemiddel: cyklofosfamid
Andre navn:
  • Cytoksan
  • CTX
  • NSC #026271
  • IND #7089
Legemiddel: leukovorin kalsium
Andre navn:
  • LCV
  • Wellcovorin
  • citrovorum faktor
  • folinsyre
  • NSC #003590
Legemiddel: asparaginase
Andre navn:
  • E coli
  • Elspar
  • NSC #109229
Legemiddel: cytarabin
Andre navn:
  • Ara-C
  • Cytosar
  • cytosin arabinosid
  • NSC #063878
Legemiddel: daunorubicinhydroklorid
Andre navn:
  • Cerubidin
  • daunomycin
  • DNR
  • NSC #82151
Legemiddel: deksametason
Andre navn:
  • Dekadron
  • NSC #034521
Legemiddel: metotreksat
Andre navn:
  • ametopterin
  • MTX
  • NSC #000740
  • IND #4291
Legemiddel: vinkristinsulfat
Andre navn:
  • VCR
  • Oncovin
  • NSC #067574
  • IND #7161
Legemiddel: merkaptopurin
Andre navn:
  • 6 MP
  • Purinethol
  • NSC #000755
Legemiddel: tioguanin
Andre navn:
  • 6-tioguanin
  • 6-TG
  • NSC #752

Hva måler studien?

Primære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 1998

Primær fullføring (Faktiske)

1. november 2002

Studiet fullført (Faktiske)

1. februar 2009

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

10. september 2004

Først lagt ut (Anslag)

13. september 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2014

Sist bekreftet

1. juli 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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. .

Abonnere