Brief Title
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
Official Title
Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)
Brief 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.
Detailed 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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response of Liver Metastases
Secondary Outcome
Overall Survival
Condition
Uveal Melanoma
Intervention
GM-CSF
Study Arms / Comparison Groups
Immunoembolization
Description: Liver embolization treatment with injection of GM-CSF.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
53
Start Date
October 2004
Completion Date
June 2012
Primary Completion Date
December 2011
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Takami Sato, M.D., Ph.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00661622
Organization ID
04F.445
Secondary IDs
R21CA103250
Responsible Party
Sponsor
Study Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Takami Sato, M.D., Ph.D., Principal Investigator, Thomas Jefferson University
Verification Date
October 2016