CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Ipilimumab, Melphalan and Dactinomycindrug
Likely dose
Ipilimumab, Melphalan and Dactinomycin 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01323517
NCT01323517Phase 2Completed
CompareCT.gov

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

Memorial Sloan Kettering Cancer Center·interventional·Posted Mar 25, 2011·Updated May 15, 2018

In Brief

A Phase 2 clinical trial evaluating Ipilimumab, Melphalan and Dactinomycin for Melanoma. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2011
Enrollment StartFeb 1, 2011
Primary CompletionAug 14, 2017
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 15.3 years ago

Interventions

Ipilimumab, Melphalan and Dactinomycindrug

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.