Clinical trial NCT00057616: Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo 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: PHASE3
Conditions: Melanoma
Neoplasm Metastasis
Keywords: Metastatic Melanoma
Melanoma
Revimid
CC5013
Lead sponsor: Celgene
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2003-04-08
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 are 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: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Sydney Cancer Centre
state: New South Wales
city: Newcastle
country: Australia
facility: Royal Newcastle Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Roayl Brisbane Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Mount HospitalOncology
state: Western Australia
city: Tallinn
country: Estonia
facility: North-Estonian Regional Hospital
city: Tartu
country: Estonia
facility: Tartu University Clinics Onkology & Haematology Clinic
city: Berlin
country: Germany
facility: Klinick fur Dermatologie
city: Bochum
country: Germany
facility: Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
city: Bonn
country: Germany
facility: Klinick fur Dermatolgie
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitatsklinik Eppendorf
city: Kiel
country: Germany
facility: Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
city: Mannheim
country: Germany
facility: Klinik fur DermatologieVenerologie und Allergologie
city: Riga
country: Latvia
facility: Latvian Onkology Centre
city: Klaipeda
country: Lithuania
facility: Klaipeda Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Onkology Institute
city: Rotterdam
country: Netherlands
facility: Daniel DenHoed Kliniek
city: Cape Town
country: South Africa
facility: Panorama Medi-Clinic / Panorama Oncology Unit
city: Durban
country: South Africa
facility: Addington Hospital
city: Hatfield, Pretoria
country: South Africa
facility: Wilgers Hospital / Wilgers Oncology Centre
city: Morningside, Johannesburg
country: South Africa
facility: Sandton Oncology Centre
city: Port Elizabeth
country: South Africa
facility: St. Georges Hospital
city: Pretoria
country: South Africa
facility: Little Company of Mary / Mary Potter Oncology Centre
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital / Department Medical Oncology
city: Westridge, Durban
country: South Africa
facility: Durban Oncology Centre
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk State Medical Academy
city: Kharkov
country: Ukraine
facility: Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
city: Kiev
country: Ukraine
facility: Scientific Research Institute of OncologySoft Tissue Department
city: Kiev
country: Ukraine
facility: Kiev City Oncology Hospital
city: Lviv
country: Ukraine
facility: Lviv State Medical University Regional Oncology Centre
city: Odessa
country: Ukraine
facility: Odessa Regional Oncology DispensaryChemotherapy Dept
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Regional Oncology Diepensary
city: Egbaston
country: United Kingdom
facility: Cancer Centre
state: Birmingham
city: Withington
country: United Kingdom
facility: Christies Hospital
state: Manchester
city: Glasgow
country: United Kingdom
facility: Beatson Oncology CentreWestern InfirmaryOncology
city: Leeds
country: United Kingdom
facility: Cancer Research BldgDivsion of Cancer Medicine Research
city: London
country: United Kingdom
facility: Roayl Free Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital Department of Oncology
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle GeneralOncology
Study officials:
References:
citation: Eisen T, Trefzer U, Hamilton A, Hersey P, Millward M, Knight RD, Jungnelius JU, Glaspy J. Results of a multicenter, randomized, double-blind phase 2/3 study of lenalidomide in the treatment of pretreated relapsed or refractory metastatic malignant melanoma. Cancer. 2010 Jan 1;116(1):146-54. doi: 10.1002/cncr.24686.