Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
Condition: Uveal Melanoma; Liver Metastases
MeSH terms: Melanoma
Intervention: GM-CSF; Embolization
Intervention description: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.; A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
Intervention MeSH terms: Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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