Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver
NCT01728051 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2013-10-23
Summary
The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted in the same patient population as well as using the same melphalan dosing as proposed in this study. This expanded access protocol will provide an experimental alternative treatment option for both physicians and patients until the Delcath CS-PHP System receives marketing approval.
Conditions
- Metastatic Liver Cancer
- Ocular Melanoma
- Cutaneous Melanoma
Interventions
- DRUG
-
Melphalan
- DEVICE
-
Percutaneous Hepatic Perfusion
Sponsors & Collaborators
-
Delcath Systems Inc.
lead INDUSTRY
Principal Investigators
-
Charles W Nutting, DO · Sky Ridge Medical Center
-
Jonathan Zager, MD · H. Lee Moffitt Cancer Center and Research Institue at University of Southern Florida
-
Mark Faries, MD · Saint John's Cancer Institute
-
James F Pingpank, MD · Univeristy of Pittsburg Cancer Center
-
Eric D Whitman, MD · Carol G. Simon Cancer Center at Morristown Memorial Hospital
-
H. Richard Alexander, MD · University of Maryland, Baltimore
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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