The purpose of this study is to determine if LC beads loaded with Doxorubicin are a safe and effective treatment for melanoma that has spread to the liver.
In this study, trans-arterial chemoembolization will be used to deliver LC beads loaded with Doxorubicin directly into liver tumors resulting from malignant melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg
University of Louisville
Louisville, Kentucky, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Incidence of Adverse Events
Adverse events were collected from all 20 subjects.
Time frame: Date of surgery through 2 years post procedure or until patient death
Percentage of Tumor Response
Progression is determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Progressive disease is defined as at least 20% increase in the sum of the longest target lesions, taking as reference the smallest sum longest diameter recorded since start of treatment OR appearance of one or more new lesions greater then 1cm in size. Percentage of tumor response will be assessed up to 1 year post treatment.
Time frame: Percentage of tumor response assessed up to 1 year post treatment.
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