Clinical trialNCT00324727CompletedPhase 3Interventional

Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma

SponsorDelcath Systems Inc.Enrollment93Intraocular MelanomaMelanoma (Skin)Metastatic Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving melphalan directly into the arteries around the tumor may kill more tumor cells. It is not yet known whether hepatic arterial infusion with melphalan is more effective than standard therapy in treating liver metastases due to melanoma. PURPOSE: This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Marybeth S. Hughes, MD
NCI - Surgery Branch
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

John Wayne Cancer Institute at Saint John'S Health Center
Santa Monica, California, United States
Swedish Medical Center
Englewood, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - Nci Clinical Trials Referral Office
Bethesda, Maryland, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
St. Luke'S Cancer Network at St. Luke'S Hospital
Bethlehem, Pennsylvania, United States
Upmc Cancer Centers
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Melphalan →Regional chemotherapySystemic chemotherapy

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Feb 2006
Primary completion: 31 Aug 2012
Completion: 31 Aug 2012
Last update posted: 21 Jun 2021
Registered enrollment: 93
Registry id: NCT00324727

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.