VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00063713
First received: July 2, 2003
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Mantle Cell Lymphoma
Drug: VELCADE TM (bortezomib) for Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Estimated Enrollment: 152
Study Start Date: June 2003
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063713

  Hide Study Locations
Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Alta Bates Medical Center
Berkeley, California, United States, 94704
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Loma Linda Cancer Research Institute
Loma Linda, California, United States, 92354
UCLA School of Medicine
Los Angeles, California, United States, 90095
Stanford University
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Cancer
Denver, Colorado, United States, 80262
United States, District of Columbia
Georgetown University Medical Center Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Illinois
The Rush Cancer Center
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospital Division
Iowa City, Iowa, United States, 52242
United States, Minnesota
North Memorial Hospital
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
Onc/Hem Associates of Kansas City
Kansas City, Missouri, United States, 64111
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
St Lukes-Roosevelt Hospital
New York, New York, United States, 10019
New York Hospital Cornell Medical Center
New York, New York, United States, 10021
Beth Israel Medical Center
New York, New York, United States, 10003
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Wake Forest, University health Sciences/Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73112
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University Hospital-Madison Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00063713     History of Changes
Obsolete Identifiers: NCT00084851
Other Study ID Numbers: M34103-053
Study First Received: July 2, 2003
Last Updated: February 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014