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

November 4, 2009
December 20, 2013
September 2009
December 2012   (final data collection date for primary outcome measure)
Incidence and grade of adverse events [ Time Frame: 2 years post procedure or until patient death ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01010984 on ClinicalTrials.gov Archive Site
Increase or decrease of tumor sizes as measured by modified RECIST criteria [ Time Frame: until patient death ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
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.

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

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stage IV Melanoma
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
Experimental: Transcatheter Arterial Chemoembolization
TACE using LC beads loaded with Doxorubicin
Intervention: Device: LC beads loaded with Doxorubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01010984
G090097
No
Robert C. Martin, University of Louisville
Robert C. Martin
  • University of Louisville
  • Thomas Jefferson University
  • M.D. Anderson Cancer Center
Study Director: Robert CG Martin, MD, PhD University of Louisville
University of Louisville
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP