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Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

23. juli 2014 oppdatert av: Children's Oncology Group

Acute Myeloid Leukemia Salvage Therapy for Patients in First Relapse or Who Fail to Achieve an Initial Remission or Who Develop AML as a Second Malignant Neoplasm

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 patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES: I. Determine the toxicity, remission rate, event-free survival, and overall survival following induction with cytarabine/mitoxantrone (ARA-C/DHAD), intensification with ARA-C and etoposide (VP-16), and consolidation with cladribine (2-CdA) and VP-16 in patients with acute myeloid leukemia (AML) that is secondary, in first relapse, or has failed initial remission induction therapy. II. Compare the remission induction rate and event-free survival on this trial with prior second-line studies (i.e., protocols CCG-243, CCG-201, and CCG-261P). III. Compare survival of patients on this trial with the survival of patients relapsing or failing to achieve an initial complete remission (CR) on previous front-line AML trials (i.e., protocols CCG-251, CCG-213, CCG-2861, and CCG-2891). IV. Determine the frequency and prognostic significance of mdr1 gene expression and p53, topoisomerase II, and deoxycytidine kinase gene mutations in these patients. V. Determine the disease-free and overall survival of patients achieving a CR on this study in relation to the post-intensification therapy received (i.e., bone marrow transplantation, chemotherapy, or no further therapy). VI. Determine the frequency and degree of abnormal cardiac function on echocardiogram or MUGA at 1 and 5 years in patients treated with mitoxantrone following anthracycline therapy during initial treatment. VII. Provide a control arm evaluating the safety of using phase I or II agents in an "upfront window" approach planned for future CCG studies. VIII. Determine the toxicity, remission rate, event-free survival, and overall survival in patients who fail to achieve a CR with ARA-C/DHAD induction and are then treated with 2-CdA/VP-16. IX. Determine the biologic characteristics, toxicity, remission rate, event-free survival, and overall survival following this treatment regimen in patients who develop AML as a second malignancy.

OUTLINE: Patients who do not achieve M1/M2a marrow following Induction proceed to Salvage Induction; all others proceed to Intensification. Patients receive Consolidation therapy on Regimen A, B, or C according to the investigator's choice. The following acronyms are used: ARA-C Cytarabine, NSC-63878 2-CdA Cladribine (2-Chlorodeoxyadenosine), NSC-105014 DHAD Mitoxantrone, NSC-301739 G-CSF Filgrastim, NSC-614629 HC Hydrocortisone, NSC-10483 HD High Dose MTX Methotrexate, NSC-740 PBSC Peripheral Blood Stem Cells TBI Total-Body Irradiation TIT Triple Intrathecal Therapy (IT ARA-C/IT HC/IT MTX) VP-16 Etoposide, NSC-141540 INDUCTION: 2-Drug Combination Chemotherapy plus CNS Prophylaxis/Therapy. ARA-C/DHAD; G-CSF; plus IT ARA-C and, if CNS disease at entry, TIT. SALVAGE INDUCTION: 2-Drug Combination Chemotherapy. 2-CdA/VP-16. INTENSIFICATION: 2-Drug Combination Chemotherapy followed, as indicated, by Radiotherapy. HD ARA-C/VP-16; followed, in patients with persistent CNS disease, CNS relapse, or chloromas, by irradiation using megavoltage equipment (minimum Co60 and maximum 6 MV x-rays or electrons). CONSOLIDATION: Regimen A: 2-Drug Combination Chemotherapy. 2-CdA/VP-16. Regimen B: Myeloablative Chemoradiotherapy followed by Hematopoietic Rescue. TBI (equipment unspecified) with electron boosts to the testes, chest, extramedullary sites, and, if indicated, craniospinal region; VP-16; followed by allogeneic or autologous bone marrow or PBSC. Regimen C: No further therapy.

PROJECTED ACCRUAL: A total of 90 patients will be entered. The study may be closed if there are 7 or more deaths in the first 45 patients who complete Intensification.

Studietype

Intervensjonell

Registrering (Faktiske)

115

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3G9
        • IWK Grace Health Centre
  • Forente stater
    • California
      • Long Beach, California, Forente stater, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, Forente stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forente stater, 90027-0700
        • Children's Hospital Los Angeles
      • Orange, California, Forente stater, 92668
        • Children's Hospital of Orange County
      • San Francisco, California, Forente stater, 94115-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Children's Hospital of Denver
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010-2970
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60637
        • University of Chicago Cancer Research Center
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Hospitals and Clinics
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Kalamazoo, Michigan, Forente stater, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City, Missouri, Forente stater, 64108
        • Children's Mercy Hospital - Kansas City
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198-3330
        • University of Nebraska Medical Center
    • New Jersey
      • New Brunswick, New Jersey, Forente stater, 08901
        • Cancer Institute of New Jersey
    • New York
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forente stater, 10016
        • Kaplan Cancer Center
      • New York, New York, Forente stater, 10032
        • Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58102
        • Veterans Affairs Medical Center - Fargo
      • Fargo, North Dakota, Forente stater, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229-3039
        • Children's Hospital Medical Center - Cincinnati
      • Cleveland, Ohio, Forente stater, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, Forente stater, 43205-2696
        • Children's Hospital of Columbus
    • Oregon
      • Portland, Oregon, Forente stater, 97201-3098
        • Doernbecher Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Children's Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232-6838
        • Vanderbilt Cancer Center
    • Texas
      • Houston, Texas, Forente stater, 77030
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forente stater, 98105
        • Children's Hospital and Medical Center - Seattle
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Comprehensive Cancer Center

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 21 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome in one of the following categories: In first relapse Failed to achieve initial complete remission Newly diagnosed secondary AML eligible Required bone marrow status: Greater than 25% blasts (M3) OR Persistent abnormal clone on cytogenetics and 5-25% blasts (M2) No Fanconi's anemia

PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times normal AST or ALT less than 4.0 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR greater than 70 mL/min per 1.73 square meters or GFR in equivalent institutional normal range Cardiovascular: Shortening fraction greater than 27% by echocardiogram or in institutional normal range OR Ejection fraction greater than 47% by radionuclide angiogram

PRIOR CONCURRENT THERAPY: No more than 1 prior treatment No prior salvage therapy No prior mitoxantrone

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: Treatment
Induction will consist of one course of cytarabine and mitoxantrone. Patients achieving a complete or partial response by the end of induction will start intensification. Intensification will consist of one course of chemotherapy (Cytarabine (Ara-C), Etoposide (VP-16), Filgrastim (G-CSF)). Patients who do not attain a CNS remission following the completion of intensification therapy, or who develop recurrence of CNS disease and have not previously received radiation therapy involving the central nervous system should receive craniospinal radiotherapy. Continuation Therapy: cladribine (2CdA), Etoposide.
Legemiddel: mitoksantronhydroklorid
Andre navn:
  • Novantrone
  • NSC-301739
Legemiddel: kladribin
Andre navn:
  • Leustatin
  • 2CdA
  • 2-klorodeoksyadenosin
Legemiddel: cytarabin
Andre navn:
  • Ara-C
  • Cytosar-U
  • Cytosin Arabinoside
Legemiddel: etoposid
Andre navn:
  • VP-16
  • VePesid
  • NSC-141540
Legemiddel: metotreksat
Andre navn:
  • MTX
  • NSC-740
Legemiddel: terapeutisk hydrokortison
Andre navn:
  • Hydrokortisonnatriumsuccinat
  • NSC-10483
Fremgangsmåte: allogen benmargstransplantasjon
Fremgangsmåte: stamcelletransplantasjon av perifert blod
Biologisk: filgrastim
Andre navn:
  • G-CSF
  • Neupogen
  • NSC-614629
Fremgangsmåte: autolog benmargstransplantasjon
Stråling: lav-LET elektronterapi
Stråling: lav-LET fotonterapi
Stråling: lav-LET kobolt-60 gammastråleterapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Estimate second remission rate and survival rate
Tidsramme: 3 years
3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate the mortality of the start of VP-16/Ara-C intensification
Tidsramme: 45 days
45 days
Compare outcomes by the ethnicity and gender
Compare outcomes by the ethnicity (and gender) in study CCG-2951, and will control for ethnicity in multivariate models comparing the treatment arms

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: Robert J. Wells, MD, Children's Hospital Medical Center, Cincinnati

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. august 1997

Primær fullføring (Faktiske)

1. mai 2001

Studiet fullført (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

1. september 2004

Først lagt ut (Anslag)

2. september 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juli 2014

Sist bekreftet

1. juli 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2951
  • CCG-2951
  • CDR0000064907 (Annen identifikator: Clinical Trials.gov)

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. .

Kliniske studier på Leukemi

Kliniske studier på mitoksantronhydroklorid

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Greece

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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