Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)

Sponsor
Astex Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00041990
Collaborator
Eisai Inc. (Industry)
40
Enrollment
8
Locations
5
Patients Per Site

Study Details

Study Description

Brief Summary

To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: decitabine (5-aza-2'deoxycytidine)
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571)
Study Start Date :
Jul 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion:
    • Histologically confirmed diagnosis of CML accelerated phase

    • Ph chromosome-positive

    • Previous treatment with imatinib mesylate resulting in:

    1. Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
    • Patients must have recovered from the side effects of previous CML therapy for accelerated phase with the exception of hydroxyurea

    • Age >/= 2 years

    • Bilirubin </= 3 x the upper limit of normal (ULN), SGOT and SGPT </= 3 x ULN, except </= 5 x ULN in leukemic involvement of the liver, serum creatinine </= 2 x ULN

    • WHO performance status 0-3

    • A negative serum hCG pregnancy test in patients of childbearing potential

    • Able to give signed informed consent directly or through a parent or guardian for minors

    Exclusion:
    • Leukemic involvement of the central nervous system

    • Active malignancy other than CML or non-melanoma cancer of the skin

    • Previous treatment for CML with another investigational agent within 28 days of study entry

    • At study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks

    • Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy

    • Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.

    • Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.

    • Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements

    • Patients with systemic, uncontrolled infections

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1City of Hope Medical CenterDuarteCaliforniaUnited States
    2Scripps ClinicEscondidoCaliforniaUnited States
    3USC/Norris Cancer CenterLos AngelesCaliforniaUnited States
    4Metro-Minnesota CCOPSt. Louis ParkMinnesotaUnited States
    5New York Medical CollegeValhallaNew YorkUnited States
    6Liberty Hematology/OncologyColumbiaSouth CarolinaUnited States
    7University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030
    8Princess Margaret HospitalTorontoOntarioCanada

    Sponsors and Collaborators

    • Astex Pharmaceuticals, Inc.
    • Eisai Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00041990
    Other Study ID Numbers:
    • DAC-013
    • DACO-013
    First Posted:
    Jul 23, 2002
    Last Update Posted:
    Dec 17, 2007
    Last Verified:
    Dec 1, 2007

    Study Results

    No Results Posted as of Dec 17, 2007