Uveal MelanomaPhase 2NCT00661622
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
A Phase 2 study testing GM-CSF and Embolization in people with Uveal Melanoma and Liver Metastases, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, Liver Metastases
- What is being tested?
- GM-CSF and Embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19317
About this study
Official title: Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)
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.
Read the 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).
- Conditions
- Uveal Melanoma, Liver Metastases
- Being tested
- GM-CSF, Embolization
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFDrug
Also called granulocyte-macrophage colony stimulating factor
2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
EmbolizationProcedure or surgery
Also called embo
A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery
| Study group | Role | What they receive |
|---|---|---|
| Immunoembolization | Experimental | Liver embolization treatment with injection of GM-CSF. Receives: Drug: GM-CSF; Procedure: Embolization |
| Plain embolization | Active comparator | Liver embolization with normal saline injected in place of GM-CSF Receives: Procedure: Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of Liver Metastases
Complete response: Disappearance of all target and non-target liver lesions
Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions
Stable disease: Absence of change which would qualify as response or progression
Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s)
Measured: Every 8 weeks
Overall Response Rate
Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.
Measured: Baseline then 3 to 4 weeks after every 2 treatments
Secondary outcomes (3)
Overall Survival
Measured from the start of the treatment to death of patients
Measured: Baseline to death
Median Progression Free Survival
Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s).
Measured: Baseline to time of progression
Systemic Progression Free Survival
Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s).
Measured: Baseline to time of progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startOct 2004
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Takami Sato, M.D., Ph.D., Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661622
- Sponsor's protocol ID
- 04F.445
- Other IDs
- R21CA103250, JT 1280
- Status last verified
- May 2025
- First submitted
- 16 Apr 2008
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)
- ClinicalTrials.gov ID
- NCT00661622
- Acronym / sponsor ID
- 04F.445
- Conditions
- Uveal Melanoma, Liver Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoembolization | Experimental | Drug: GM-CSF, Procedure: EmbolizationLiver embolization treatment with injection of GM-CSF. |
| Plain embolization | Active comparator | Procedure: EmbolizationLiver embolization with normal saline injected in place of GM-CSF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM-CSFAlso: granulocyte-macrophage colony stimulating factor2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver. | Drug | Immunoembolization |
| EmbolizationAlso: emboA catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery | Procedure or surgery | Immunoembolization, Plain embolization |
Primary outcome
Response of Liver Metastases
Time frame: Every 8 weeks
Complete response: Disappearance of all target and non-target liver lesions Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions Stable disease: Absence of change which would qualify as response or progression Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s)
Overall Response Rate
Time frame: Baseline then 3 to 4 weeks after every 2 treatments
Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.
3 secondary outcomes
Overall Survival
Time frame: Baseline to death
Median Progression Free Survival
Time frame: Baseline to time of progression
Systemic Progression Free Survival
Time frame: Baseline to time of progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takami Sato, M.D., Ph.D. principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CSF and Embolization in people with Uveal Melanoma and Liver Metastases, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of Liver Metastases (time frame: Every 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.