A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate
No
H. Richard Alexander, MD, FACS
Study Chair
NCI - Surgery Branch
United States: Federal Government
990123
NCT00019786
August 1999
January 2006
Name | Location |
---|---|
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |