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

Primary Purpose

Melanoma, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC 5013
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Metastatic Melanoma, Metastatic Malignant Melanoma, Revimid, CC5013

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arizona Cancer Center
  • University of Southern California Norris Cancer Center
  • UCLA
  • St. Francis Memorial Hospital
  • Outpatient Clinic
  • University of Colorado
  • The Harold Lever Regional Cancer Center
  • Lakeland Regional Cancer Center
  • Mount Sinai Comprehensive Cancer Center
  • Lutheran General
  • Carle Clinic
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Ctr
  • Spectrum Health
  • Ellis Fischel Cancer Center
  • Washington University School of Medicine
  • Melanoma Center of St Louis
  • Biomedical Research Alliance of New York
  • Memorial Sloan Kettering Cancer Center
  • The Linder Clinical Trial Center
  • Cleveland Clinic Foundation
  • Penn State Hershey Medical Center
  • UPMC Cancer Pavillion
  • Sarah Cannon Cancer Center
  • MD Anderson Cancer Center
  • Tom Baker Cancer Center
  • Cross Cancer Institute
  • Cancer Care Manitoba
  • Qell Health Sciences Center
  • Princess Margaret Hospital
  • L'Hotel Dieu de Quebec

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 5, 2003
Last Updated
June 23, 2005
Sponsor
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00055562
Brief Title
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma
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 Type
Interventional

2. Study Status

Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Neoplasm Metastasis
Keywords
Metastatic Melanoma, Metastatic Malignant Melanoma, Revimid, CC5013

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
274 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC 5013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Southern California Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6956
Country
United States
Facility Name
St. Francis Memorial Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Outpatient Clinic
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
The Harold Lever Regional Cancer Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33804-1057
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Lutheran General
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1270
Country
United States
Facility Name
Carle Clinic
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214-2698
Country
United States
Facility Name
Beth Israel Deaconess Medical Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Melanoma Center of St Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Biomedical Research Alliance of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Linder Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
UPMC Cancer Pavillion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Qell Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2y9
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
L'Hotel Dieu de Quebec
City
Quebec
ZIP/Postal Code
PQ G1R 2J6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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