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Completed

NCT Number: NCT00661622

Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of 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.

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Key information

Conditions

Uveal Melanoma Eye Diseases Eye Neoplasms Liver Metastases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19317, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GM-CSF

Drug

2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.

Other names: granulocyte-macrophage colony stimulating factor

embolization

Procedure

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

Other names: embo

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Overall Survival

    Time frame: Baseline to death

    Measured from the start of the treatment to death of patients

  2. Median Progression Free Survival

    Time frame: Baseline to time of progression

    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).

  3. Systemic Progression Free Survival

    Time frame: Baseline to time of progression

    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).

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)

Important dates

Study start
2004
Primary completion
2011
Study completion
2012
First posted
Apr 18, 2008
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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