Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia

Sponsor
Cell Genesys (Industry)
Overall Status
Completed
CT.gov ID
NCT00116467
Collaborator
(none)
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Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).

Condition or Disease Intervention/Treatment Phase
  • Biological: GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line
Study Start Date :
Mar 1, 2001
Actual Study Completion Date :
Jan 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.

    • No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.

    Exclusion Criteria:
    • Prior myelodysplastic disorder, or treatment-related leukemia.

    • Prior myeloproliferative disease.

    • Acute promyelocytic leukemia (APL).

    • Prior chemotherapy for a malignant or nonmalignant disorder.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143
    2 University of Chicago Chicago Illinois United States 60637
    3 Johns Hopkins University Baltimore Maryland United States 21231
    4 Dana Farber Cancer Institute Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Cell Genesys

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00116467
    Other Study ID Numbers:
    • K-0009
    • K-0009
    First Posted:
    Jun 30, 2005
    Last Update Posted:
    Dec 24, 2007
    Last Verified:
    Dec 1, 2007

    Study Results

    No Results Posted as of Dec 24, 2007