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

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study, trans-arterial chemoembolization will be used to deliver LC beads loaded with Doxorubicin directly into liver tumors resulting from malignant melanoma.

Official Title
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Transcatheter Arterial Chemoembolization With Doxorubicin-loaded LC Beads in the Treatment of Liver-dominant Metastases in Patients With Stage IV Metastatic Melanoma

Conditions
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Stage IV Melanoma

Intervention / Treatment
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* Device: LC beads loaded with Doxorubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unresectable, measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST and EASL criteria (2D/3D-EASL) or MRI (Extent of Necrosis) Patients ≥ 18 years of age, > 35kg, of any race or sex, who have histological or radiological proof of melanoma to the liver ECOG performance status < 3 Patient chooses to participate and has signed the informed consent document Patients with unilobar disease who can be treated superselectively in a single session or patients with bilobar disease who can have both lobes able to be treated within 3 - 4 weeks in separate sessions Patients with patent main portal vein Ocular melanoma is allowed Patients with clinically and radiologically stable brain metastasis from melanoma can be included Patients with liver dominant disease (>50% overall tumor burden) Prior systemic therapy for metastatic disease is allowed Non-pregnant with an acceptable contraception in premenopausal women and fertile men Hematological function: ANC ≥1.5 x 109/L, platelets ≥ 75 x 109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible) 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Arterial Chemoembolization<br>TACE using LC beads loaded with Doxorubicin | Device: LC beads loaded with Doxorubicin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Adverse events were collected from all 20 subjects. | Date of surgery through 2 years post procedure or until patient death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Percentage of tumor response assessed up to 1 year post treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic melanoma, stage IV melanoma, metastatic melanoma to the liver