Melanoma Clinical Trial
Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma
Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving melphalan directly into the arteries around the tumor may kill more tumor cells. It is not yet known whether hepatic arterial infusion with melphalan is more effective than standard therapy in treating liver metastases due to melanoma.
PURPOSE: This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma.
Full Description
OBJECTIVES:
Primary
Compare the hepatic progression-free survival of patients with unresectable liver metastases secondary to ocular or cutaneous melanoma treated with percutaneous isolated hepatic arterial perfusion (PHP) with melphalan with subsequent venous hemofiltration vs the best alternative standard treatment.
Secondary
Determine the response rate and duration of response in patients treated with melphalan PHP.
Determine the patterns of recurrence in patients treated with melphalan PHP.
Compare the overall survival of patients treated with these regimens.
Compare the safety and tolerability of these regimens in these patients.
Determine the pharmacokinetics of melphalan after PHP.
OUTLINE: This is a multicenter study. Patients are stratified according to site of disease (ocular vs cutaneous). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo an isolated hepatic arterial infusion of melphalan over 30 minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity.
Arm II: Patients receive the best alternative therapy comprising supportive care, systemic or regional chemotherapy, hepatic artery (chemo)-embolization, or any other appropriate therapy at the National Cancer Institute or therapy at the discretion of their physician. Patients may cross over to arm I if they have evidence of disease progression.
Blood samples are collected periodically for pharmacokinetic analysis of melphalan.
After completion of study treatment, patients are followed periodically for 4 years and then annually for survival.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed liver metastases secondary to cutaneous or ocular melanoma
Unresectable disease
Predominantly in the parenchyma of the liver
Measurable disease by CT scan and/or MRI
Limited unresectable extrahepatic disease allowed provided the life-limiting component of progressive disease is in the liver, including, but not limited to, any of the following:
Up to 4 pulmonary nodules, each < 1 cm in diameter
Retroperitoneal lymph nodes < 3 cm in diameter
Less than 10 skin or subcutaneous metastases < 1 cm in diameter
Asymptomatic bone metastases that are eligible for or have undergone palliative external-beam radiotherapy
Solitary metastasis to any site that can be resected
PATIENT CHARACTERISTICS:
Life expectancy ≥ 3 months
ECOG performance status 0-2
Bilirubin < 3.0 mg/dL
PT within 2 seconds of upper limit of normal (ULN)
AST/ALT ≤ 10 times ULN
Platelet count > 75,000/mm^3
Hematocrit > 27% (may be achieved with a transfusion)
Absolute neutrophil count ≥ 1,300/mm^3
Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min
Fertile patients must use effective contraception
Not pregnant or nursing
Negative pregnancy test
No history of congestive heart failure
LVEF ≥ 40%
No significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease
FEV_1 ≥ 30%
DLCO ≥ 40% of predicted
Weight ≥ 35 kg
No untreated active bacterial infection with systemic manifestations (e.g., malaise, fever, and leucocytosis)
No severe allergic reactions to iodine contrast unless reaction can be controlled by antihistamines and/or steroids
No known hypersensitivity to melphalan
No positive serology for HIV, hepatitis B surface antigen, or hepatitis C antibody (pharmacokinetics portion of the study only)
No known latex allergy
No Childs B or C cirrhosis
No evidence of portal hypertension by history, endoscopy, or radiological study
No prior history of gastrinoma
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 1 month since prior chemotherapy, radiotherapy, or biologic therapy for this cancer and recovered
No prior regionally delivered melphalan
No prior Whipple procedure
No concurrent immunosuppressive therapy
No concurrent chronic anticoagulation therapy
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 12 Locations for this study
Santa Monica California, 90404, United States
Englewood Colorado, 80113, United States
Tampa Florida, 33612, United States
Baltimore Maryland, 21201, United States
Bethesda Maryland, 20892, United States
Morristown New Jersey, 07962, United States
Albany New York, 12208, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Bethlehem Pennsylvania, 18015, United States
Pittsburgh Pennsylvania, 15232, United States
Galveston Texas, 77555, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.