Clinical trial NCT00055562: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Melanoma
Neoplasm Metastasis
Keywords: Metastatic Melanoma
Metastatic Malignant Melanoma
Revimid
CC5013
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2003-03-06
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California Norris Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Francisco
country: United States
facility: St. Francis Memorial Hospital
state: California
city: Santa Monica
country: United States
facility: Outpatient Clinic
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Waterbury
country: United States
facility: The Harold Lever Regional Cancer Center
state: Connecticut
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Park Ridge
country: United States
facility: Lutheran General
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Ctr
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: St. Louis
country: United States
facility: Melanoma Center of St Louis
state: Missouri
city: New York
country: United States
facility: Biomedical Research Alliance of New York
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: The Linder Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillion
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Qell Health Sciences Center
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Quebec
country: Canada
facility: L'Hotel Dieu de Quebec
Study officials:
References: