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Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer

Sponsor
Transgene (Industry)
Overall Status
Terminated
CT.gov ID
NCT00040170
Collaborator
University of California, Los Angeles (Other), The Cleveland Clinic (Other), University of Arizona (Other)
50
Enrollment
3
Locations
16.7
Patients Per Site

Study Details

Study Description

Brief Summary

This study involves the use of an experimental product, TG4010. The purpose of the study is to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.

Condition or Disease Intervention/Treatment Phase
  • Biological: MVA-MUC1-IL2
 Phase 2

Detailed Description

The experimental product, TG4010, is a modified vaccinia virus (already used in humans) into which two (2) genes have been placed. One gene is for a protein (MUC1) found in cancer cells. The second gene is for human interleukin 2 (IL2) which the body's immune system makes to help it fight cancer. The TG4010 is given as an injection under the skin (subcutaneous) once a week for six weeks followed by a schedule of every three weeks or every three weeks for the first twelve (12) weeks. If the therapy is working, it can be continued for up to 9 months until no further improvement or until the patient gets worse for as long as it is tolerated.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate
Study Start Date :
May 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Rising PSA after surgery or radiation for prostate cancer
    Exclusion Criteria:

    • Metastasis or local disease

    • Prior hormone treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724
    2 UCLA Los Angeles California United States 90095
    3 Cleveland Clinic Foundation Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • Transgene
    • University of California, Los Angeles
    • The Cleveland Clinic
    • University of Arizona

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00040170
    Other Study ID Numbers:
    • TG4010.03
    • NCT00040976
    First Posted:
    Jun 25, 2002
    Last Update Posted:
    Nov 2, 2006
    Last Verified:
    Oct 1, 2006
    Keywords provided by , ,
    Adenocarcinoma of the prostate
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Nov 2, 2006