Liver Transplantation and Uveal Malignant Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Oslo University Hospital
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01311466
First received: March 7, 2011
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

Patients with uveal malignatnt melanoma with liver metastases have a dismal prognosis with a median survival of less than 12 months. There is noe established treatment showing increased overall survival. In this study we will determin if liver transplantation will result in long term survival in patients with liver only metastases from uveal malignant melanoma.


Condition Intervention Phase
Uveal Malignant Melanoma
Procedure: Liver transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Over all survival

Estimated Enrollment: 6
Study Start Date: January 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liver transplantation Procedure: Liver transplantation
Other Name: Liver transplantation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:Uveal malignant melanoma, liver only metastases, ECOG 0-1 -

Exclusion Criteria:Extra hepatic disease, previous other maligency, previous organ transplantation

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311466

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, N0310
Contact: Svein Dueland, MD, Ph.D    47-22934000    svein.dueland@oslo-universitetssykehus.no   
Principal Investigator: Svein Dueland, MD, Ph.D         
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Svein Dueland, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01311466     History of Changes
Other Study ID Numbers: S-06408
Study First Received: March 7, 2011
Last Updated: May 29, 2013
Health Authority: Norway:Regional Ethics Committee

Keywords provided by Oslo University Hospital:
Liver transplantation
Overall survival

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 29, 2014