Know Cancer

or
forgot password

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 CenterNew York, New York  10021
MD Anderson Cancer CenterHouston, Texas  77030-4096
Cleveland Clinic FoundationCleveland, Ohio  44195
Washington University School of MedicineSaint Louis, Missouri  63110
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
University of ColoradoDenver, Colorado  80217
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Lakeland Regional Cancer CenterLakeland, Florida  33805
Sarah Cannon Cancer CenterNashville, Tennessee  37203
UCLALos Angeles, California  90095
Spectrum HealthGrand Rapids, Michigan  49503
Penn State Hershey Medical CenterHershey, Pennsylvania  17033
University of Arizona Cancer CenterTucson, Arizona  85724
University of Southern California Norris Cancer CenterLos Angeles, California  90089
St. Francis Memorial HospitalSan Francisco, California  94109
Outpatient ClinicSanta Monica, California  90404
The Harold Lever Regional Cancer CenterWaterbury, Connecticut  06708
Lutheran GeneralPark Ridge, Illinois  60068-1270
Carle ClinicUrbana, Illinois  61801
Beth Israel Deaconess Medical CtrBoston, Massachusetts  02215-5400
Melanoma Center of St LouisSt. Louis, Missouri  63131
Biomedical Research Alliance of New YorkNew York, New York  10016
The Linder Clinical Trial CenterCincinnati, Ohio  45219
UPMC Cancer PavillionPittsburgh, Pennsylvania  15232