Expired Study
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Philadelphia, Pennsylvania 19317


Purpose:

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.


Study 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).


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


Study is Available At:


Original ID:

04F.445


NCT ID:

NCT00661622


Secondary ID:

R21CA103250


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Thomas Jefferson University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

53


Enrollment Type:

Actual


Overall Contact Information

Official Name:Takami Sato, M.D., Ph.D.
Principal Investigator
Thomas Jefferson University

Study Dates

Start Date:October 2004
Completion Date:June 2012
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 8, 2016
First Received Date:April 16, 2008
First Results Date:March 24, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Systemic Progression Free Survival
Time Frame:Baseline to time of progression
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Median Progression Free Survival
Time Frame:Baseline to time of progression
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:Baseline to death
Safety Issues:False
Description:Measured from the start of the treatment to death of patients
Outcome Type:Primary Outcome
Measure:Overall Response Rate
Time Frame:Baseline then 3 to 4 weeks after every 2 treatments
Safety Issues:False
Description: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 wil
Outcome Type:Primary Outcome
Measure:Response of Liver Metastases
Time Frame:Every 8 weeks
Safety Issues:False
Description: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 o

Study Interventions

Intervention Type:Drug
Name:GM-CSF
Description:2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.
Arm Name:Immunoembolization
Other Name:granulocyte-macrophage colony stimulating factor
Intervention Type:Procedure
Name:Embolization
Description: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
Arm Name:Immunoembolization
Other Name:embo

Study Arms

Study Arm Type:Active Comparator
Arm Name:Plain embolization
Description:Liver embolization with normal saline injected in place of GM-CSF
Study Arm Type:Experimental
Arm Name:Immunoembolization
Description:Liver embolization treatment with injection of GM-CSF.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Thomas Jefferson University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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