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Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00050596
Collaborator
(none)
11
Locations
24
Duration (Months)

Study Details

Study Description

Brief Summary

The primary objectives of the study are to determine the safety and activity of multiple doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in combination with MDX-010

Condition or Disease Intervention/Treatment Phase
  • Drug: MDX-010 / MDX-010 + Docetaxel
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study Comparing 4 Monthly Doses of MDX-010 (CTLA-4) as a Single Agent or Used in Combination With a Single Dose of Docetaxel in Patients With Hormone-Refractory Prostate Cancer
Study Start Date :
Nov 1, 2002
Actual Primary Completion Date :
Nov 1, 2004
Actual Study Completion Date :
Nov 1, 2004

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:

    • Clinical diagnosis of adenocarcinoma of the prostate.

    • Metastatic prostate cancer (positive bone scan or measurable disease).

    • Progressive disease after androgen deprivation.

    • No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).

    Exclusion Criteria:

    • Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for greater than or equal to 5 years.

    • Previous occurrence of autoimmune disease.

    • Active infection requiring therapy including HIV or chronic hepatitis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Advanced Clinical Therapeutics Tucson Arizona United States 85712
    2 Pacific Shores Medical Group Long Beach California United States 90813
    3 San Diego Uro-Research San Diego California United States 92101
    4 LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus) New Orleans Louisiana United States 70112
    5 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    6 University Urological Research Institute Providence Rhode Island United States 02906
    7 Grand Strand Urology Myrtle Beach South Carolina United States 29572
    8 Urology Associates of North Texas Arlington Texas United States 76012
    9 Utah Cancer Specialists Salt Lake City Utah United States 84106
    10 Salt Lake Research Salt Lake City Utah United States 84124
    11 Seattle Cancer Center Alliance Seattle Washington United States 98109-1023

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00050596
    Other Study ID Numbers:
    • MDX010-07
    • CA184-019
    First Posted:
    Dec 17, 2002
    Last Update Posted:
    Jun 27, 2011
    Last Verified:
    Jun 1, 2011
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Docetaxel
    Ipilimumab

    Study Results

    No Results Posted as of Jun 27, 2011