Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection … (NCT00661622) | Clinical Trial Compass
CompletedPhase 2
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
United States53 participantsStarted 2004-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response of Liver Metastases
Timeframe: Every 8 weeks
2
Overall Response Rate
Timeframe: Baseline then 3 to 4 weeks after every 2 treatments
Trial details
NCT IDNCT00661622
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University