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
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of The 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|
- To determine progression free survival at one year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine the safety of additional Ipilimumab. Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine response rates of combination therapy. Tumor assessment will be measured by the immune related response criteria (irRC). [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progression free survival, from time of ILI, will be determined by measuring the index lesions, non-index lesions, and new lesions as described below. Patients with deep lesions will have repeat CT Scan evaluation to quantitate the lesions.
- To define the immunologic events and signatures at the tumor site and in the periphery that corresponds to response to Ipilimumab. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Summaries of antibody response, comparison of pretreatment with post-ipilimumab and end of treatment will be assessed for percent of CD4 and CD8 cells as well as CD25, FOXP3, ICOS, CD45, CD67 and CD152 cells among others.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Ipilimumab, Melphalan and Dactinomycin
This is a single-institution phase II trial with a primary outcome of progression free survival (PFS).
Drug: Ipilimumab, Melphalan and Dactinomycin
Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323517
|Contact: Charlotte Ariyan, MD, PhD||212-639-6280|
|Contact: Mary Brady, MD, FACS||212-639-8347|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Charlotte Ariyan, MD, PhD 212-639-6280|
|Contact: Mary Brady, MD, FACS 212-639-8347|
|Principal Investigator: Charlotte Ariyan, MD, PhD|
|Principal Investigator:||Charlotte Ariyan, MD,PhD||Memorial Sloan-Kettering Cancer Center|