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Liver Transplantation and Uveal Malignant Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01311466
First Posted: March 9, 2011
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital
  Purpose
Patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. There is no established treatment showing increased overall survival. The study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.

Condition Intervention
Uveal Malignant Melanoma Procedure: Liver transplantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Non-randomized Study to Assess the Benefit of Liver Transplantation in Patients With Liver Metastasis After Ocular Malignant Melanoma (Uveal Melanoma)

Resource links provided by NLM:


Further study details as provided by Svein Dueland, Oslo University Hospital:

Primary Outcome Measures:
  • Over all survival [ Time Frame: 1 year ]
    Patient survival after livertransplantation


Enrollment: 2
Study Start Date: January 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liver transplantation
The liver transplantation will be performed as described by the standard protocol, Liver Transplantation Protocol (Version 2006) at the Oslo University Hospital
Procedure: Liver transplantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uveal malignant melanoma
  • Liver metastases
  • ECOG 0-1

Exclusion Criteria:

  • Extra hepatic disease
  • Previous other malignancy
  • Previous organ transplantation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311466


Locations
Norway
Oslo University Hospital
Oslo, Norway, N0310
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Svein Dueland, MD, PhD Oslo University Hospital, Radium hospitalet
  More Information

Responsible Party: Svein Dueland, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01311466     History of Changes
Other Study ID Numbers: S-06408
First Submitted: March 7, 2011
First Posted: March 9, 2011
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by Svein Dueland, 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
Liver Extracts
Hematinics