Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven liver cancer meeting 1 of the following criteria:

• Primary unresectable hepatocellular or cholangiocellular carcinoma

• Metastatic cancer to the liver originating from one of the following:

• Intraocular melanoma (closed to accrual as of 10/17/03)

• Islet cell carcinoma

• Adenocarcinoma of the colon or rectum limited to parenchyma of the liver

• No evidence of other unresectable extrahepatic colorectal metastasis

• Other neuroendocrine tumors, such as carcinoid tumors

• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 100,000/mm^3

• Hematocrit greater than 27.0%

• WBC at least 2,500/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)

• PT no greater than 2 seconds above upper limit of normal

• Elevated SGOT and SGPT allowed if not due to hepatitis

• No biopsy-proven cirrhosis or evidence of significant portal hypertension

• No prior or concurrent veno-occlusive disease

• Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• Congestive heart failure allowed if LVEF ≥ 40%

Pulmonary:

• No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age

Other:

• Weight greater than 30 kg

• Not pregnant or nursing

• Negative pregnancy test

• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 month since prior anticancer biologic therapy and recovered

Chemotherapy:

• At least 1 month since prior anticancer chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 month since prior anticancer radiotherapy and recovered

Surgery:

• Not specified

Other:

• Prior intrahepatic arterial infusion therapy allowed

• No chronic use of anticoagulants

• No concurrent immunosuppressive therapy