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

Phase 2CompletedNCT00019786

National Institutes of Health Clinical Center (CC)67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Islet Cell Tumor Liver Cancer

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes