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A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.
OBJECTIVES: * Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan. * Determine the disease-free and overall survival of patients treated with this regimen. OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour. Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression. PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Start Date
August 1, 1999
Completion Date
January 1, 2006
Last Updated
March 23, 2012
67
ESTIMATED participants
isolated perfusion
DRUG
melphalan
DRUG
conventional surgery
PROCEDURE
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
NCT04704661
NCT06696768
Data Source & Attribution
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