Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver Metastases
Ciliary Body and Choroid Melanoma, Medium/Large Size
Ciliary Body and Choroid Melanoma, Small Size
Extraocular Extension Melanoma
Metastatic Intraocular Melanoma
Recurrent Intraocular Melanoma
Stage IV Intraocular Melanoma
Radiation: yttrium Y 90 glass microspheres
Other: laboratory biomarker analysis
Early Phase 1
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Sequential Hepatic Radioembolization and Systemic Ipilimumab in Patients With Uveal Melanoma Metastatic to Liver|
- Number of patients that experience grade 3-4 toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 3 weeks after discontinuation of study treatment ]
- Number of patients with an overall response of liver metastasis according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ]Sequential hepatic radioembolization and systemic ipilimumab will be considered potentially efficacious if >3/12 patients achieve objective responses because the upper limit of the corresponding exact 95% confidence interval will be >57%. The best overall response of liver metastases, from the start of hepatic radioembolization will be used for the efficacy analysis.
- Overall survival [ Time Frame: From the hepatic radioembolization procedure until death, assessed up to 5 years ]Number of patients still alive after 5 years.
- Progression-free (PFS) survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From the hepatic radioembolization to confirmation of progression or death, assessed up to 5 years ]Number of patients progression free survival at 5 years. Hepatic and extrahepatic PFS will be evaluated separately.
- Tumor genotype/phenotype Biomarkers [ Time Frame: pre-treatment (Day 0 and 28), post-hepatic radioembolization (Day 71), post ipilimumab (Year 5) ]A number of correlative studies will be performed. Data will be analyzed longitudinally using methods such as repeated measures ANOVA; however, the primary analyses will be at specific time points (e.g., pre-treatment, post-hepatic radioembolization, post ipilimumab), and these analyses will be conducted using primarily non-parametric methods (e.g., Wilcoxon signed-rank or rank sum test). All tests will be two sided with a significance level of .05, and no adjustment for multiple comparisons will be made due to the exploratory nature of these studies.
|Study Start Date:||December 2012|
|Study Completion Date:||February 2016|
|Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (yttrium Y 90 glass microspheres, ipilimumab)
Patients undergo radioembolization with yttrium Y 90 glass microspheres via hepatic arterial infusion on day 1. Beginning on day 29, patients also receive ipilimumab 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.
Other Names:Radiation: yttrium Y 90 glass microspheres
Given via hepatic arterial infusion
Other Name: TheraSphereOther: laboratory biomarker analysis
I. To estimate the safety and efficacy of sequential hepatic radioembolization and systemic ipilimumab in patients with uveal melanoma metastatic to liver.
I. To evaluate effects on regulators of tumor immunity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730157
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Michael McNamara, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|