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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT02115243
Phase
PHASE1
Status
Completed

Conditions

  • Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2014
Status verified
Oct 2018
Primary completion
Dec 7, 2015
Completion
Dec 7, 2015

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Ipi/ILI
    Patients will receive ipilimumab followed by ILI.

Primary Outcome Measure

Safety and tolerability [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27707-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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