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

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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