Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00050102
Collaborator
(none)
9
16

Study Details

Study Description

Brief Summary

The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.

Condition or Disease Intervention/Treatment Phase
  • Drug: MDX-010 (CTLA-4)
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.
Study Start Date :
Oct 1, 2002
Actual Primary Completion Date :
Feb 1, 2004
Actual Study Completion Date :
Feb 1, 2004

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

    • Clinical diagnosis of unresectable metastatic melanoma.

    • No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma.

    Exclusion Criteria

    Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:

    • Any other prior malignancy, except for the following: 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 >=5 years.

    • Active autoimmune disease.

    • Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724
    2 Pacific Shores Medical Group Long Beach California United States 90813
    3 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033
    4 Northern California Melanoma Center San Francisco California United States 94109
    5 Cancer Institute Medical Group Santa Monica California United States 90404
    6 Indiana Oncology/ Hematology Consultants Indianapolis Indiana United States 46237
    7 Piedmont Oncology Specialists Charlotte North Carolina United States 28207
    8 Joe Arrington Cancer. Research & Treatment Center Lubbock Texas United States 79410
    9 Huntsman Cancer Institute Salt Lake City Utah United States 84112

    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:
    NCT00050102
    Other Study ID Numbers:
    • MDX010-08
    • CA184-013
    First Posted:
    Nov 22, 2002
    Last Update Posted:
    Jan 28, 2011
    Last Verified:
    Jan 1, 2011
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2011