Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055562
Recruitment Status : Completed
First Posted : March 6, 2003
Last Update Posted : June 24, 2005
Information provided by:

Brief Summary:
Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles.

Condition or disease Intervention/treatment Phase
Melanoma Neoplasm Metastasis Drug: CC 5013 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2 or IFN Based Therapy
Study Start Date : January 2003
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Understand and voluntarily sign an informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug.
  • Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055562

  Hide Study Locations
United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
University of Southern California Norris Cancer Center
Los Angeles, California, United States, 90089
Los Angeles, California, United States, 90095-6956
St. Francis Memorial Hospital
San Francisco, California, United States, 94109
Outpatient Clinic
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80010
United States, Connecticut
The Harold Lever Regional Cancer Center
Waterbury, Connecticut, United States, 06708
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33804-1057
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Lutheran General
Park Ridge, Illinois, United States, 60068-1270
Carle Clinic
Urbana, Illinois, United States, 61801
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214-2698
Beth Israel Deaconess Medical Ctr
Boston, Massachusetts, United States, 02215-5400
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Melanoma Center of St Louis
St. Louis, Missouri, United States, 63131
United States, New York
Biomedical Research Alliance of New York
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
The Linder Clinical Trial Center
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203-1632
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Qell Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 2y9
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
L'Hotel Dieu de Quebec
Quebec, Canada, PQ G1R 2J6
Sponsors and Collaborators
Celgene Corporation Identifier: NCT00055562     History of Changes
Obsolete Identifiers: NCT00060281
Other Study ID Numbers: CDC-5013-MEL-001
First Posted: March 6, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2004

Keywords provided by Celgene:
Metastatic Melanoma
Metastatic Malignant Melanoma

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents