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VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00063713
Collaborator
(none)
152
Enrollment
35
Locations
4.3
Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.

Condition or Disease Intervention/Treatment Phase
  • Drug: VELCADE TM (bortezomib) for Injection
 Phase 2

Detailed Description

VELCADE is approved in multiple myeloma for patients who have received two prior therapies and their disease came back or got worse while on their second therapy. VELCADE is currently being studied in other types of cancers.

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Dec 1, 2005

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

    • 18 years of age or older

    • Confirmed diagnosis of mantle cell lymphoma

    • Documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. At least one of those regimens must have included an anthracycline or mitoxantrone. Relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.

    • At least 1 measurable or evaluable site of disease

    • Voluntary consent

    Exclusion Criteria

    • Previous treatment with VELCADE

    • Any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug

    • Radiation therapy within 3 weeks before the first dose of study drug

    • Major surgery with 2 weeks before the first dose of study drug

    • Rituximab, Campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug

    • Radioimmunotherapy or other toxin immunoconjugates such as Zevalin or Bexxar within 10 weeks before the first dose of study drug

    • History of allergic reactions to boron or mannitol compounds

    • Diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug

    • Active systemic infection requiring treatment

    • Women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)

    • Serious medical or psychiatric illness likely to interfere with participation in this clinical study

    • Concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Alabama United States 35294
    2 Alta Bates Medical Center Berkeley California United States 94704
    3 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    4 Loma Linda Cancer Research Institute Loma Linda California United States 92354
    5 UCLA School of Medicine Los Angeles California United States 90095
    6 Stanford University Palo Alto California United States 94304
    7 University of Colorado Cancer Denver Colorado United States 80262
    8 Georgetown University Medical Center Lombardi Cancer Center Washington District of Columbia United States 20007
    9 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
    10 The Emory Clinic Atlanta Georgia United States 30322
    11 The Rush Cancer Center Chicago Illinois United States 60612
    12 University of Chicago Medical Center Chicago Illinois United States 60637
    13 Indiana University Cancer Center Indianapolis Indiana United States 46202
    14 University of Iowa Hospital Division Iowa City Iowa United States 52242
    15 North Memorial Hospital Robbinsdale Minnesota United States 55422
    16 Onc/Hem Associates of Kansas City Kansas City Missouri United States 64111
    17 University of Nebraska Medical Center Omaha Nebraska United States 68198
    18 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
    19 Beth Israel Medical Center New York New York United States 10003
    20 St Lukes-Roosevelt Hospital New York New York United States 10019
    21 Memorial Sloan Kettering Cancer Center New York New York United States 10021
    22 New York Hospital Cornell Medical Center New York New York United States 10021
    23 University of Rochester Medical Center Rochester New York United States 14642
    24 University of North Carolina Chapel Hill North Carolina United States 27599
    25 Wake Forest, University health Sciences/Comprehensive Cancer Center Winston-Salem North Carolina United States 27157
    26 Cancer Care Associates Oklahoma City Oklahoma United States 73112
    27 Cancer Care Associates Tulsa Oklahoma United States 74136
    28 Oregon Health Science University Portland Oregon United States 97239
    29 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104
    30 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    31 Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224
    32 Vanderbilt University Nashville Tennessee United States 37232
    33 Sarah Cannon Cancer Center Nashville Tennessee United States
    34 MD Anderson Cancer Center Houston Texas United States 77030
    35 University Hospital-Madison Wisconsin Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • Millennium Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00063713
    Other Study ID Numbers:
    • M34103-053
    • NCT00084851
    First Posted:
    Jul 4, 2003
    Last Update Posted:
    Feb 11, 2008
    Last Verified:
    Feb 1, 2008
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Mantle-Cell
    Bortezomib

    Study Results

    No Results Posted as of Feb 11, 2008