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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010984
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
University of Louisville
Thomas Jefferson University
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage IV Melanoma Device: LC beads loaded with Doxorubicin Not Applicable

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Arterial Chemoembolization With Doxorubicin-loaded LC Beads in the Treatment of Liver-dominant Metastases in Patients With Stage IV Metastatic Melanoma
Study Start Date : September 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Transcatheter Arterial Chemoembolization
TACE using LC beads loaded with Doxorubicin
Device: LC beads loaded with Doxorubicin
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

Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Date of surgery through 2 years post procedure or until patient death ]
    Adverse events were collected from all 20 subjects.

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Percentage of tumor response assessed up to 1 year post treatment. ]
    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.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010984

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77230
Sponsors and Collaborators
Robert C. Martin
University of Louisville
Thomas Jefferson University
M.D. Anderson Cancer Center
Study Director: Robert CG Martin, MD, PhD University of Louisville

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert C. Martin, Professor University of Louisville, University of Louisville Identifier: NCT01010984     History of Changes
Other Study ID Numbers: G090097
First Posted: November 10, 2009    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018
Last Verified: March 2018

Keywords provided by Robert C. Martin, University of Louisville:
metastatic melanoma
stage IV melanoma
metastatic melanoma to the liver

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action