MedTrace Logo

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

NCT00661622 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-05-16

Study results available
· View outcomes & findings →

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

Interventions

DRUG

GM-CSF

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

PROCEDURE

Embolization

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Takami Sato, M.D., Ph.D. · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2011-12-31
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661622 on ClinicalTrials.gov