Liver Transplantation and Uveal Malignant Melanoma

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01311466
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 57
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Uveal Malignant Melanoma	Procedure: Liver transplantation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• 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)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Over all survival [1 year]

   Patient survival after livertransplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Uveal malignant melanoma

• Liver metastases

• ECOG 0-1

Exclusion Criteria:

• Extra hepatic disease

• Previous other malignancy

• Previous organ transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	N0310

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Principal Investigator: Svein Dueland, MD, PhD, Oslo University Hospital, Radium hospitalet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Svein Dueland, MD PhD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT01311466
• Other Study ID Numbers: S-06408
• First Posted: Mar 9, 2011
• Last Update Posted: Oct 23, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Svein Dueland, MD PhD, Oslo University Hospital: Liver transplantation; Overall survival
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Oct 23, 2017