Status:
COMPLETED
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Uveal Melanoma
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wi...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00661622
Start Date
October 1 2004
End Date
June 1 2012
Last Update
May 16 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19317