LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma

Exclusion Criteria

• •Adequate renal function: Creatinine ≤2.0mg/dl and GFR \>30
• •Adequate liver function: total bilirubin ≤ 2.5 mg/dl, ALT, AST ≤ 5 times ULN, albumin ≥ 2.5mg/dl
• •All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise specified above
• •Women who are pregnant or breast feeding
• •Patients eligible for curative treatment such as resection or radiofrequency ablation
• •Active bacterial, viral or fungal infection within 72 hours of study entry
• •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis \& Ti) or any cancer curatively treated \< 5 years prior to study entry
• •Contraindication to hepatic artery embolization procedures:
• •Severe peripheral vascular disease precluding catheterization
• •Large shunt as determined by the investigator (pretesting with TcMAA not required) at the time of first angiogram
• •Hepatofugal blood flow
• •Main portal vein occlusion (e.g. thrombus or tumor)
• •Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment.
• •Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated
• •Advanced liver disease (\> 80% liver replacement)
• •Other significant medical or surgical condition, or any medication or treatment that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation
• •Any contraindication for doxorubicin administration:
• •WBC \<3000 cells/mm3
• •Neutrophils \<1500 cells/mm3
• •Deficient cardiac function defined as a LVEF of \<50% normal