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

Phase 2
18 Years
Not Enrolling
Uveal Melanoma, Liver Metastases

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Trial Information

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

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

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

- 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

- 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 SGOT and 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

Type of Study:


Study Design:

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

Outcome Measure:

Determine whether immuno-embolization of the liver with GM-CSF produces clinical benefit in patients with metastatic uveal melanoma

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Takami Sato, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

June 2012

Related Keywords:

  • Uveal Melanoma
  • Liver Metastases
  • Melanoma
  • Neoplasm Metastasis
  • Uveal Neoplasms
  • Liver Neoplasms



Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541