Status:
COMPLETED
Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma
Lead Sponsor:
Delcath Systems Inc.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
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 dire...
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 hepati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00324727
Start Date
February 1 2006
End Date
August 1 2012
Last Update
June 21 2021
Active Locations (12)
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1
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
2
Swedish Medical Center
Englewood, Colorado, United States, 80113
3
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
4
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201