Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


Purpose:

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.


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


NCT ID:

NCT00019786


Primary Contact:

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


Backup Contact:

N/A


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: September 19, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.