Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma
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|ClinicalTrials.gov Identifier: NCT02115243|
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : October 29, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Melanoma||Drug: Ipilimumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Neoadjuvant Ipilimumab Followed by Melphalan Via Isolated Limb Infusion for Patients With Unresectable In-transit Extremity Melanoma|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||December 7, 2015|
|Actual Study Completion Date :||December 7, 2015|
Patients will receive ipilimumab followed by ILI.
- Safety and tolerability [ Time Frame: 2 years ]The primary objective is to characterize the safety and tolerability of combining IPI and ILI by determining the MTD of IPI when used prior to ILI with LPAM.
- Response Rate [ Time Frame: 3 years ]Estimate the complete response rate to ipi plus ILI in the patients who received the MTD of ipi.
- Progression Free Survival [ Time Frame: 2 years ]
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): NCT02115243
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27707|
|Principal Investigator:||Douglas Tyler, MD||Duke University|
|Principal Investigator:||April K Salama, MD||Duke University|