Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Heating melphalan to several degrees above body temperature and infusing it to the affected area directly around the tumor may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Melphalan

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