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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 2

Conditions: Liver Metastases; Uveal Melanoma

Treatments: Drug: GM-CSF; Procedure: Embolization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00661622

JT 1280 (Other Identifier)

R21CA103250 (U.S. NIH Grant/Contract)

04F.445

Details and patient eligibility

About

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).

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups

Immunoembolization

Experimental group

Description:

Liver embolization treatment with injection of GM-CSF.

Treatment:

Procedure: Embolization

Drug: GM-CSF

Plain embolization

Active Comparator group

Description:

Liver embolization with normal saline injected in place of GM-CSF

Treatment:

Procedure: Embolization