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

NCT ID: NCT00055562

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma Neoplasm Metastasis

Keywords

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Metastatic Melanoma Metastatic Malignant Melanoma Revimid CC5013

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CC 5013

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

* Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role lead

Locations

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University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

University of Southern California Norris Cancer Center

Los Angeles, California, United States

Site Status

UCLA

Los Angeles, California, United States

Site Status

St. Francis Memorial Hospital

San Francisco, California, United States

Site Status

Outpatient Clinic

Santa Monica, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

The Harold Lever Regional Cancer Center

Waterbury, Connecticut, United States

Site Status

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Site Status

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Site Status

Lutheran General

Park Ridge, Illinois, United States

Site Status

Carle Clinic

Urbana, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Ctr

Boston, Massachusetts, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Melanoma Center of St Louis

St Louis, Missouri, United States

Site Status

Biomedical Research Alliance of New York

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

The Linder Clinical Trial Center

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, United States

Site Status

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Tom Baker Cancer Center

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Site Status

Qell Health Sciences Center

Halifax, Nova Scotia, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

L'Hotel Dieu de Quebec

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CDC-5013-MEL-001

Identifier Type: -

Identifier Source: org_study_id

NCT00060281

Identifier Type: -

Identifier Source: nct_alias