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

June 23, 2005 updated by: Celgene Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

274

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

March 5, 2003

First Submitted That Met QC Criteria

March 5, 2003

First Posted (Estimate)

March 6, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-5013-MEL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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