Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF

NCT00661622 | Completed Phase 2 Results DMC

• 3 other identifiers: 04F.445R21CA103250JT 1280
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Uveal Melanoma; Liver Metastases

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Baseline then 3 to 4 weeks after every 2 treatments

Secondary Outcomes (3)

• Overall Survival

  Baseline to death

• Median Progression Free Survival

  Baseline to time of progression

• Systemic Progression Free Survival

  Baseline to time of progression

Study Arms (2)

Immunoembolization

EXPERIMENTAL

Liver embolization treatment with injection of GM-CSF.

Drug: GM-CSF; Procedure: Embolization

Plain embolization

ACTIVE COMPARATOR

Liver embolization with normal saline injected in place of GM-CSF

Procedure: Embolization

Interventions

GM-CSF DRUG

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

Also known as: granulocyte-macrophage colony stimulating factor

Immunoembolization

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

Also known as: embo

Immunoembolization; Plain embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19317, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors; Embolization, Therapeutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Results Point of Contact

• Title: Takami Sato, MD
• Organization: Thomas Jefferson University

Takami.Sato@jefferson.edu

215-955-8874

Study Officials

• Takami Sato, M.D., Ph.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: October 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: May 16, 2025
• Results First Posted: June 1, 2015

Record last verified: 2025-05

Locations

US (1)