Melanoma Clinical Trial
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
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.
Full 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).
Eligibility Criteria
Inclusion Criteria:
Metastatic uveal melanoma in the liver with histological confirmation
Ability/willingness to give informed consent
ECOG performance status of 0 or 1
Adequate renal, liver and bone marrow function
Exclusion Criteria:
Solitary liver metastasis that is amenable to surgical removal
Presence of symptomatic liver failure including ascites and hepatic encephalopathy
Presence of extra-hepatic metastases
Untreated brain metastases
Uncontrolled hypertension or congestive heart failure or acute myocardial infarction within 6 months of entry
Presence of any other medical complication that imply survival of less than six months
Uncontrolled sever bleeding tendency or active GI bleeding
Significant allergic reaction to contrast dye or GM-CSF
Immunosuppressive treatments such as systemic steroids, radiation to pelvis or systemic chemotherapy within 4 weeks
Previous embolization of the hepatic artery or intrahepatic arterial chemotherapy of liver metastasis
Active hepatitis with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) greater than 5 x normal
HIV infection positive by ELISA
Pregnancy or breast feeding women
Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
Significant arteriovenous shunt identified on angiography of the hepatic artery
Occlusion of main portal vein or inadequate collateral flow around an occluded portal vein
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There is 1 Location for this study
Philadelphia Pennsylvania, 19317, United States
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