drugset / Trial / NCT00661622
Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
Phase 2
Completed
53 enrolled
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
National Cancer Institute (NCI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2004-10
- Primary completion
- 2011-12
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-CSF | Protein / enzyme biologic | 2000 ug | Other |