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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01323517|
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Ipilimumab, Melphalan and Dactinomycin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 2011|
|Primary Completion Date :||August 14, 2017|
|Study Completion Date :||August 14, 2017|
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.
- To determine progression free survival at one year. [ Time Frame: 1 year ]
- 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 ]
- To determine response rates of combination therapy. Tumor assessment will be measured by the immune related response criteria (irRC). [ Time Frame: 2 years ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323517
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Charlotte Ariyan, MD,PhD||Memorial Sloan Kettering Cancer Center|