Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma
- Conditions
- Intraocular MelanomaMelanoma (Skin)Metastatic Cancer
- Interventions
- Drug: regional chemotherapyDrug: systemic chemotherapyProcedure: hepatic artery embolization
- Registration Number
- NCT00324727
- Lead Sponsor
- Delcath Systems Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm II regional chemotherapy 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. Arm II systemic chemotherapy 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. Arm II hepatic artery embolization 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. Arm I melphalan 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.
- Primary Outcome Measures
Name Time Method Hepatic progression free survival Treatment to time of progression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
John Wayne Cancer Institute at Saint John's Health Center
🇺🇸Santa Monica, California, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
🇺🇸Bethesda, Maryland, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
St. Luke's Cancer Network at St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States