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Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma

Unresectable Melanoma Clinical Trial

Official title:
A Phase I Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma

Clinical Trial Summary

The purpose of this study is to determine safety profile, initial response rates and progression free survival for the combination therapy of neoadjuvant system ipilimumab followed by ILI with melphalan in patients with in transit melanoma.

Hypothesis:

The combination of regional LPAm plus systemic ipilimumab will lead to a larger response rate than either therapy alone.

The combination of regional LPAm plus systemic ipilimumab will cause larger changes in immune cell populations than are seen with either therapy along.

Changes in immune cell populations will predict progression free survival.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02115243
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date May 2014
Completion date December 7, 2015
View Details
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