NCT01730157

Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver Metastases

Pilot Study of Sequential Hepatic Radioembolization and Systemic Ipilimumab in Patients With Uveal Melanoma Metastatic to Liver

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies radioembolization and ipilimumab in treating patients with uveal melanoma with liver metastases. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radioembolization together with ipilimumab may kill more tumor cells in patients with uveal melanoma

Detailed description

PRIMARY OBJECTIVE: I. To estimate the safety and efficacy of sequential hepatic radioembolization and systemic ipilimumab in patients with uveal melanoma metastatic to liver. SECONDARY OBJECTIVES: I. To evaluate effects on regulators of tumor immunity. OUTLINE: Patients undergo radioembolization with yttrium Y 90 glass microspheres via hepatic arterial infusion on day 1. Beginning on day 29, patients also receive ipilimumab intravenously (IV) over 90 minutes. Treatment with ipilimumab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.

Conditions

• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Ciliary Body and Choroid Melanoma, Small Size
• Extraocular Extension Melanoma
• Iris Melanoma
• Liver Metastases
• Metastatic Intraocular Melanoma
• Recurrent Intraocular Melanoma
• Stage IV Intraocular Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	ipilimumab	Given IV
RADIATION	yttrium Y 90 glass microspheres	Given via hepatic arterial infusion
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-11-21
• Last updated: 2016-03-10

Locations

1 site across 1 country: United States