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

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00055562

Purpose

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	Intervention	Phase
Melanoma Neoplasm Metastasis	Drug: CC 5013	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Estimated Enrollment:	274
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2004

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055562

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Locations

United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA
Los Angeles, California, United States, 90095-6956
Outpatient Clinic
Santa Monica, California, United States, 90404
University of Southern California Norris Cancer Center
Los Angeles, California, United States, 90089
St. Francis Memorial Hospital
San Francisco, California, United States, 94109
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
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33804-1057
United States, Illinois
Lutheran General
Park Ridge, Illinois, United States, 60068-1270
Carle Clinic
Urbana, Illinois, United States, 61801
United States, Massachusetts
Beth Israel Deaconess Medical Ctr
Boston, Massachusetts, United States, 02215-5400
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214-2698
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
Melanoma Center of St Louis
St. Louis, Missouri, United States, 63131
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
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
L'Hotel Dieu de Quebec
Quebec, Canada, PQ G1R 2J6
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

Sponsors and Collaborators

Celgene Corporation

More Information

No publications provided

Study ID Numbers:	CDC-5013-MEL-001
Study First Received:	March 5, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00055562 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Metastatic Melanoma
Metastatic Malignant Melanoma
Revimid
CC5013

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Nerve Tissue
Lenalidomide
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors

Neoplasms
Neoplastic Processes
Pathologic Processes
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 22, 2009