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A Study to Evaluate PT-523 in Patients With Refractory Leukemia

Sponsor
Spectrum Pharmaceuticals, Inc (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00129558
Collaborator
(none)
0
Enrollment
6
Locations
74
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with refractory leukemia.

Condition or Disease Intervention/Treatment Phase
  • Drug: PT-523 for Injection
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of PT-523 in Patients With Refractory Leukemia
Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.

    • Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II.

    • ECOG performance status 0 - 2.

    • Adequate organ function and bone marrow reserve.

    • At least 4 weeks must have elapsed from the time of major surgery.

    • Use of appropriate contraceptive method.

    • Signed patient informed consent.

    Exclusion Criteria:

    • Known human immunodeficiency virus (HIV).

    • Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.

    • Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.

    • Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC, Kennth Norris Jr. Comprehensive Cancer Center Los Angeles California United States 90033-1048
    2 UCLA School of Medicine Los Angeles California United States 90095-3075
    3 University of Chicago Chicago Illinois United States 60637
    4 Duke University Medical Center Durham North Carolina United States 27710
    5 Wake Forest University School of Medicine Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1082
    6 University of Texas M. D. Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Spectrum Pharmaceuticals, Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Spectrum Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT00129558
    Other Study ID Numbers:
    • HBS103
    First Posted:
    Aug 12, 2005
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Leukemia

    Study Results

    No Results Posted as of Dec 4, 2013