Expired Study
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Bethesda, Maryland 20892


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.

Study summary:

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.


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



Primary Contact:

Study Chair
H. Richard Alexander, MD, FACS
NCI - Surgery Branch

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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