Back to resultsHepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma
Intraocular Melanoma, Melanoma (Skin), Metastatic Cancer
About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring liver metastases, extraocular extension melanoma, stage IV melanoma, recurrent melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size
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
Sites / Locations
- John Wayne Cancer Institute at Saint John's Health Center
- Swedish Medical Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Greenebaum Cancer Center at University of Maryland Medical Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Cancer Center of Albany Medical Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- St. Luke's Cancer Network at St. Luke's Hospital
- UPMC Cancer Centers
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
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.
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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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