drugset / Trial / NCT01323517

Addition of Ipilimumab (MDX-010) To Isolated Limb Infusion (ILI) With Standard Melphalan and Dactinomycin In The Treatment of Advanced Unresectable Melanoma of The Extremity

NCT01323517

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see the effect of adding a systemic study drug, Ipilimumab, to two standard chemotherapy drugs, Melphalan and Dactinomycin. The study drug Ipilimumab is an antibody to a normal protein found in the body, CTLA-4. This protein normally allows the immune system (the body's natural defense system that helps fight infections) uses to quiet an immune response. The study drug works by blocking this protein and allowing the immune system to become more active. This study will investigate the effects, of combining ILI (using two standard drugs to treat melanoma, Melphalan and Dactinomycin), with the study drug, Ipilimumab on advanced Melanoma cancer.

Timeline

Start
2011-02
Primary completion
2017-08-14
Completion
2017-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 10 mg/kg Intravenous
Background Dactinomycin Protein / enzyme biologic Other
Background Melphalan Small molecule Other

Indications