Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer
Liver Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable cancer of the parenchyma of the liver Liver metastases allowed Limited unresectable extrahepatic disease (including but not limited to the following) is allowed provided the life-threatening component of progressive disease is in liver: Up to 4 pulmonary nodules each less than 1 cm in diameter Retroperitoneal lymph nodes less than 3 cm in diameter Fewer than 10 skin or subcutaneous metastases less than 1 cm in diameter Asymptomatic bone metastases that have been or can be palliated with radiotherapy Solitary metastasis to any site that can be resected Prior therapy with intrahepatic perfusion with or without hepatic arterial infusion with floxuridine is allowed provided patient had a radiographic partial response of 3-months duration PATIENT CHARACTERISTICS: Age: 14 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm^3 Absolute neutrophil count at least 1,300/mm^3 Hematocrit greater than 27% Hepatic: Bilirubin no greater than 2.0 mg/dL PT within 2 seconds of upper limit of normal No biopsy-proven cirrhosis with evidence of portal hypertension by history, endoscopy, or radiologic study Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No prior congestive heart failure with LVEF less than 40% Pulmonary: No chronic obstructive pulmonary disease No other chronic pulmonary disease FEV_1 at least 30% of predicted DLCO at least 40% of predicted Other: Weight greater than 35 kg HIV negative No active infections No severe allergic reaction to iodine contrast not controlled by antihistamines or steroids No known prior hypersensitivity reaction to melphalan Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior biologic therapy for the malignancy and recovered Chemotherapy: See Disease Characteristics At least 1 month since prior chemotherapy for the malignancy and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 1 month since prior radiotherapy for the malignancy and recovered Surgery: Not specified Other: No concurrent chronic anticoagulants No concurrent immunosuppressive drugs
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support