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Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia

22. januar 2013 opdateret af: National Cancer Institute (NCI)

A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase

This phase I trial is studying the side effects and best dose of rebeccamycin analog in treating patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast phase. Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop cancer cells from dividing so they stop growing or die

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

I. Determine the maximum tolerated dose and dose-limiting toxicity of rebeccamycin analogue (XL119) in patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blastic phase.

OUTLINE: This is a dose-escalation study.

Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR. Patients achieving a partial response (PR) or hematologic improvement (HI) receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • M D Anderson 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of 1 of the following:

    • Acute myeloid leukemia

    • Myelodysplastic syndromes, including 1 of the following:

      • Refractory anemia with excess blasts (RAEB)
      • RAEB in transformation
      • Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts
    • Acute lymphoblastic leukemia
    • Chronic myelogenous leukemia in blastic phase

  • Relapsed or refractory disease, defined as 1 of the following:

    • Failed to achieve a complete response (CR) to a standard induction regimen
    • Relapsed after achieving a CR
  • Failed last cytotoxic regimen before study entry
  • No alternate, potentially curative option available
  • No known CNS disease
  • Performance status - ECOG 0-2
  • SGOT and SGPT normal
  • Bilirubin normal
  • Creatinine normal
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119)
  • No concurrent uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior allogeneic stem cell transplantation
  • No concurrent prophylactic hematopoietic colony-stimulating factors (CSF)
  • No epoetin alfa or hematopoietic CSF during course 1 of study therapy
  • More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea
  • More than 7 days since prior radiotherapy
  • Recovered from all prior therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer agents or therapies
  • No other concurrent antileukemic agents or therapies
  • No other concurrent investigational agents or therapies
  • No other concurrent cytotoxic agents

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: Treatment (becatecarin)
Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 1 additional course beyond CR. Patients achieving a PR or HI receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Andet: laboratoriebiomarkøranalyse
Korrelative undersøgelser
Medicin: becatecarin
Givet IV
Andre navne:
  • BMS-181176
  • rebeccamycin analog
  • rebeccamycinanalog, tartratsalt
  • XL119

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum tolerated dose of becatecarin
Tidsramme: 21 days
Graded using the NCI CTCAE version 3.0.
21 days

Sekundære resultatmål

Resultatmål
Tidsramme
Survival
Tidsramme: From date of first study drug administration to the date of death of the patients, assessed up to 3 years
From date of first study drug administration to the date of death of the patients, assessed up to 3 years
Time to progression
Tidsramme: From the date of first study drug administration to the date that the patient is withdrawn because of clinical or radiographic progressive disease, or death from any cause, assessed up to 3 years
From the date of first study drug administration to the date that the patient is withdrawn because of clinical or radiographic progressive disease, or death from any cause, assessed up to 3 years
Time to treatment failure
Tidsramme: From the date of first study drug administration to the date of withdrawal from the study for any reason other than study closure, assessed up to 3 years
From the date of first study drug administration to the date of withdrawal from the study for any reason other than study closure, assessed up to 3 years
Duration of response
Tidsramme: From the date of first objective response to the date of progression, assessed up to 3 years
From the date of first objective response to the date of progression, assessed up to 3 years
Time to response
Tidsramme: From the date of first study drug administration until the first objective documentation of response, assessed up to 3 years
From the date of first study drug administration until the first objective documentation of response, assessed up to 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

National Cancer Institute (NCI)

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. maj 2004

Primær færdiggørelse (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først indsendt

8. juli 2004

Først indsendt, der opfyldte QC-kriterier

9. juli 2004

Først opslået (Skøn)

12. juli 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2012-02609
  • U01CA062461 (U.S. NIH-bevilling/kontrakt)
  • MDA-2003-0909
  • CDR0000373813 (Registry Identifier: PDQ (Physician Data Query))

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 Kronisk myelomonocytisk leukæmi

Kliniske forsøg med laboratoriebiomarkøranalyse

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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