A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion (PHP) (Delcath System) Versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver
Sponsor study identifier
Secondary identifiers
interventional
93
1 country
12
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
August 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
May 10, 2006
Actual (reported)May 11, 2006
Actual (reported)August 2012
Actual (reported)August 2012
Actual (reported)Hepatic progression free survival
Treatment to time of progression
Patients undergo an isolated hepatic arterial infusion of melphalan over 30 minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity.
Patients receive the best alternative therapy comprising supportive care, systemic or regional chemotherapy, hepatic artery (chemo)-embolization, or any other appropriate therapy at the National Cancer Institute or therapy at the discretion of their physician. Patients may cross over to arm I if they have evidence of disease progression.
Given throug isolated hepatic artery infusion
Patients receive the best alternative therapy
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, 90404, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956, United States
Marybeth S. Hughes, MD
NCI - Surgery Branch
93 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2006
First Posted
May 11, 2006
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Patients receive the best alternative therapy
Patients receive the best alternative therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Cancer Center of Albany Medical Center
Albany, New York, 12208, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210-1240, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0361, United States
Primary Completion
August 2012
Actual (reported)Study Completion
August 2012
Actual (reported)Last Updated
June 21, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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