Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
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.
Islet Cell Tumor
Drug: isolated perfusion
Procedure: conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver|
- Response rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Patterns of recurrence [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||August 1999|
|Study Completion Date:||January 2006|
- 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.
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||H. Richard Alexander, MD, FACS||NCI - Surgery Branch|