Clinical trial NCT00661622: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveal Melanoma
Liver Metastases
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Response of Liver Metastases
timeFrame: Every 8 weeks
measure: Overall Response Rate
timeFrame: Baseline then 3 to 4 weeks after every 2 treatments
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline to death
measure: Median Progression Free Survival
timeFrame: Baseline to time of progression
measure: Systemic Progression Free Survival
timeFrame: Baseline to time of progression
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Takami Sato, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: