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

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2011

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

Intervention(s) in this Clinical Trial

• Device: LC beads loaded with Doxorubicin
  • During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads will be delivered to the liver tumor(s). Total Doxorubicin dose is 150mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Transcatheter Arterial Chemoembolization
  • TACE using LC beads loaded with Doxorubicin

Primary Measures

• Incidence and grade of adverse events
  • Time Frame: 2 years post procedure or until patient death
    Safety Issue?: Yes

Secondary Measures

• Increase or decrease of tumor sizes as measured by modified RECIST criteria
  • Time Frame: until patient death
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Louisville

Overall Clinical Trial Officials and Contacts

Robert CG Martin, MD, PhD Study Director University of Louisville  

Overall Contact: Tiffany Metzger, BS 502-629-3383 tlmetz02@louisville.edu

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010984

Study ID Number: G090097

ClinicalTrials.gov Identifier: NCT01010984

Health Authority: United States: Food and Drug Administration