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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01728051 on ClinicalTrials.gov