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.

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

Conditions

MelanomaNeoplasm Metastasis

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

October 2002; Study completion: December 2004

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

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

Total Enrolment

274

Contact Details

Australian Capital Territory

  • The Canberra Hospital, Garran, Australian Capital Territory, 2605, Australia

New South Wales

  • Sydney Cancer Centre, Camperdown, New South Wales, 2145, Australia
  • Westmead Hospital, Westmead, New South Wales, 2145, Australia
  • Royal Newcastle Hospital, Newcastle, New South Wales, 2300, Australia
  • Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia

Queensland

  • Roayl Brisbane Hospital, Herston, Queensland, 4029, Australia
  • Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia

South Australia

  • Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia

Tasmania

  • Royal Hobart Hospital, Hobart, Tasmania, 7001, Australia

Victoria

  • Cabrini Hospital, Malvern, Victoria, 3144, Australia

Western Australia

  • Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia
  • Mount Hospital Oncology, Perth, Western Australia, 6009, Australia

Results of study