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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma, Neoplasm Metastasis

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CDC-5013-MEL-001

NCT ID:

NCT00055562

Start Date:

January 2003

Completion Date:

December 2004

Related Keywords:

  • Melanoma
  • Neoplasm Metastasis
  • Metastatic Melanoma
  • Metastatic Malignant Melanoma
  • Revimid
  • CC5013
  • Neoplasms
  • Melanoma
  • Neoplasm Metastasis

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center Houston, Texas  77030-4096
Cleveland Clinic Foundation Cleveland, Ohio  44195
Washington University School of Medicine Saint Louis, Missouri  63110
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140
University of Colorado Denver, Colorado  80217
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Ellis Fischel Cancer Center Columbia, Missouri  65203
Lakeland Regional Cancer Center Lakeland, Florida  33805
Sarah Cannon Cancer Center Nashville, Tennessee  37203
UCLA Los Angeles, California  90095
Spectrum Health Grand Rapids, Michigan  49503
Penn State Hershey Medical Center Hershey, Pennsylvania  17033
University of Arizona Cancer Center Tucson, Arizona  85724
University of Southern California Norris Cancer Center Los Angeles, California  90089
St. Francis Memorial Hospital San Francisco, California  94109
Outpatient Clinic Santa Monica, California  90404
The Harold Lever Regional Cancer Center Waterbury, Connecticut  06708
Lutheran General Park Ridge, Illinois  60068-1270
Carle Clinic Urbana, Illinois  61801
Beth Israel Deaconess Medical Ctr Boston, Massachusetts  02215-5400
Melanoma Center of St Louis St. Louis, Missouri  63131
Biomedical Research Alliance of New York New York, New York  10016
The Linder Clinical Trial Center Cincinnati, Ohio  45219
UPMC Cancer Pavillion Pittsburgh, Pennsylvania  15232