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Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia

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

Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by melphalan and peripheral stem cell transplantation in treating children who have newly diagnosed acute myeloid leukemia that has not been treated previously.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES: I. Determine the feasibility and toxicity of timed sequential remission induction and consolidation in children with newly diagnosed acute myeloid leukemia. II. Determine the feasibility and toxicity of a single high dose of melphalan with peripheral blood stem cell rescue following an intense timed sequential induction and consolidation in these children.

OUTLINE: This is a multicenter study. Remission induction: Patients receive daunorubicin IV over 15 minutes on days 1-3, cytarabine IV continuously on days 1-7, oral thioguanine daily on days 1-7, and cytarabine intrathecally (IT) on day 1. Cytarabine IV over 3 hours is administered every 12 hours on days 10-12. Filgrastim (G-CSF) is administered IV or subcutaneously (SQ) beginning on day 13 and continuing until blood counts recover. On approximately day 28, patients undergo a bone marrow aspirate and biopsy to assess response. Patients who have attained an M1 or M2a status proceed to consolidation or, if a 5/5 or 6/6 HLA matched sibling donor is available, proceed to allogeneic bone marrow transplantation. Patients with greater than 25% blasts go off study. Consolidation 1: Patients receive daunorubicin IV over 15 minutes on days 1 and 2, cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, and asparaginase on days 2 and 9. G-CSF IV or SQ begins on day 10 and continues until blood counts recover. Consolidation 2: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. G-CSF IV or SQ begins on day 6 and continues until blood counts recover. Peripheral blood stem cells (PBSC) are collected after the second course of consolidation. Consolidation 3: Treatment is repeated as in consolidation 1. Patients who remain in morphologic remission after consolidation 3 proceed with therapy. Patients receive melphalan IV over 30 minutes on day -2, then PBSC are reinfused on day 0. G-CSF IV or SQ begins on day 1 and continues until blood counts recover. Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 8 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama Comprehensive Cancer Center
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Palo Alto, California, Forenede Stater, 94304
        • Lucile Packard Children's Hospital at Stanford
      • San Diego, California, Forenede Stater, 92123-4282
        • Children's Hospital and Health Center
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital - Atlanta
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60614
        • Children's Memorial Hospital, Chicago
    • Maine
      • Scarborough, Maine, Forenede Stater, 04074
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231
        • Johns Hopkins Oncology Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Children's Hospital of Michigan
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63104
        • Cardinal Glennon Children's Hospital
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Tomorrows Children's Institute
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine
    • Texas
      • Dallas, Texas, Forenede Stater, 75235-9154
        • Simmons Cancer Center - Dallas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Cook Children's Medical Center - Fort Worth
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Midwest Children's Cancer Center

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 (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS: Histologically proven, previously untreated primary acute myeloid leukemia (AML) Isolated granulocytic sarcoma (myeloblastoma) allowed Patients with cytopenias and bone marrow blasts greater than 5% but less than 30% eligible only if there is karyotypic abnormality characteristic of de novo AML (t(8;21), inv16, t(9;11), etc.) OR unequivocal presence of megakaryoblasts No acute promyelocytic leukemia (M3) No Down syndrome

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Uric acid no greater than 8.0 mg/dL Cardiovascular: Cardiac function normal by echocardiogram Pulmonary: No uncontrolled, life threatening pneumonia Other: No uncontrolled, life threatening sepsis or meningitis Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy

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: Chemo + STEM cell
See detailed description.
Medicin: asparaginase
Andre navne:
  • E coli
  • Elspar
  • NSC #109229
Medicin: cytarabin
Andre navne:
  • Cytosar
  • cytosin arabinosid
  • NSC #063878
  • AraC
Medicin: daunorubicin hydrochlorid
Andre navne:
  • Cerubidin
  • daunomycin
  • DNR
  • NSC #82151
Medicin: thioguanin
Andre navne:
  • 6-thioguanin
  • 6-TG
  • NSC #000752
Procedure: perifer blodstamcelletransplantation
Biologisk: filgrastim
Andre navne:
  • Granulocytkoloni-stimulerende faktor
  • r-metHuG-CSF
  • NSC #614629
  • Neupogen®
  • GCSF
Medicin: melphalan
Andre navne:
  • Alkeran
  • L-PAM
  • L-phenylalanin sennep
  • L-sarcolysin
  • NSC #008806

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy
Tidsramme: Length of study
To determine the feasibility and toxicity of an intensive regimen that uses timed-sequential therapy as a strategy for both remission induction and consolidation of newly diagnosed children with AML.
Length of study
Feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue
Tidsramme: Length of study
To test the feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue following an intense timed-sequential induction and consolidation.
Length of study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Make observations regarding PCR evidence of Minimal Residual Disease
Tidsramme: Length of study
To make observations regarding PCR evidence of Minimal Residual Disease in patients with relevant specific translocations who obtain a clinical remission.
Length of study

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: Craig A. Hurwitz, MD, Maine Children's Cancer Program at Barbara Bush Children's Hospital

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

  • Hurwitz CA, Chang M, Graham M, et al.: Timed-sequential remission induction and intensification followed by stem cell rescue for childhood AML -a POG pilot study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1553, 2002.

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. oktober 1999

Primær færdiggørelse (Faktiske)

1. oktober 2002

Studieafslutning (Faktiske)

1. marts 2007

Datoer for studieregistrering

Først indsendt

10. december 1999

Først indsendt, der opfyldte QC-kriterier

19. maj 2004

Først opslået (Skøn)

20. maj 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. 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

  • 9822
  • POG-9822
  • CDR0000067253

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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