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

NCT00055562 | Completed Phase 2

• 1 other identifier: CDC-5013-MEL-001
• Study Type: interventional
• Target: 274
• Locations: 2 countries
• Sites: 31

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.

Conditions

Melanoma; Neoplasm Metastasis

Keywords

Metastatic Melanoma; Metastatic Malignant Melanoma; Revimid; CC5013

Interventions

CC 5013 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (31)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Southern California Norris Cancer Center

Los Angeles, California, 90089, United States

Location

UCLA

Los Angeles, California, 90095-6956, United States

Location

St. Francis Memorial Hospital

San Francisco, California, 94109, United States

Location

Outpatient Clinic

Santa Monica, California, 90404, United States

Location

University of Colorado

Aurora, Colorado, 80010, United States

Location

The Harold Lever Regional Cancer Center

Waterbury, Connecticut, 06708, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33804-1057, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Lutheran General

Park Ridge, Illinois, 60068-1270, United States

Location

Carle Clinic

Urbana, Illinois, 61801, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214-2698, United States

Location

Beth Israel Deaconess Medical Ctr

Boston, Massachusetts, 02215-5400, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Melanoma Center of St Louis

St Louis, Missouri, 63131, United States

Location

Biomedical Research Alliance of New York

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

The Linder Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203-1632, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Qell Health Sciences Center

Halifax, Nova Scotia, B3H 2y9, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

L'Hotel Dieu de Quebec

Québec, Quebec, PQ G1R 2J6, Canada

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2003
• First Posted: March 6, 2003
• Study Start: January 1, 2003
• Study Completion: December 1, 2004
• Last Updated: June 24, 2005

Record last verified: 2004-05

Locations

CA (6); US (25)