Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF

Liver Metastases Clinical Trial

Official title: Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)

Status Completed

Clinical Trial Summary

Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). It is hoped with this novel approach that:

• tumor cells will die due to a loss of their blood supply,

• local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and

• a systemic immune response against tumor cells may develop.

Clinical Trial Description

Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Metastases
• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

• NCT number: NCT00661622
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Completion date: June 2012