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

This study has been completed.
Sponsor:
Collaborators:
University of Louisville
Thomas Jefferson University
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville
ClinicalTrials.gov Identifier:
NCT01010984
First received: November 4, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Stage IV Melanoma
Device: LC beads loaded with Doxorubicin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Incidence and grade of adverse events [ Time Frame: 2 years post procedure or until patient death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Increase or decrease of tumor sizes as measured by modified RECIST criteria [ Time Frame: until patient death ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 doxorubicn will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010984

Locations
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
Investigators
Study Director: Robert CG Martin, MD, PhD University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: Robert C. Martin, Professor University of Louisville, University of Louisville
ClinicalTrials.gov Identifier: NCT01010984     History of Changes
Other Study ID Numbers: G090097
Study First Received: November 4, 2009
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
metastatic melanoma
stage IV melanoma
metastatic melanoma to the liver

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014