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

NCT01010984 | Completed Results

• 1 other identifier: G090097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Stage IV Melanoma

Keywords

metastatic melanoma; stage IV melanoma; metastatic melanoma to the liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Tumor Response

  Percentage of tumor response assessed up to 1 year post treatment.

Study Arms (1)

Transcatheter Arterial Chemoembolization

EXPERIMENTAL

TACE using LC beads loaded with Doxorubicin

Device: LC beads loaded with Doxorubicin

Interventions

LC beads loaded with Doxorubicin DEVICE

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

Transcatheter Arterial Chemoembolization

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert C. Martin: lead
• University of Louisville: collaborator
• Thomas Jefferson University: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (3)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77230, United States

Location

Related Publications (2)

• Rostas JW, Tam AL, Sato T, Scoggins CR, McMasters KM, Martin RCG 2nd. Health-related quality of life during trans-arterial chemoembolization with drug-eluting beads loaded with doxorubicin (DEBDOX) for unresectable hepatic metastases from ocular melanoma. Am J Surg. 2017 Nov;214(5):884-890. doi: 10.1016/j.amjsurg.2017.07.007. Epub 2017 Jul 21.

  PMID: 28754534 DERIVED

• Rostas J, Tam A, Sato T, Kelly L, Tatum C, Scoggins C, McMasters K, Martin RCG 2nd. Image-Guided Transarterial Chemoembolization With Drug-Eluting Beads Loaded with Doxorubicin (DEBDOX) for Unresectable Hepatic Metastases from Melanoma: Technique and Outcomes. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1392-1400. doi: 10.1007/s00270-017-1651-z. Epub 2017 May 15.

  PMID: 28508253 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Robert Martin, MD, PhD
• Organization: University of Louisville

robert.martin@louisville.edu

502-629-3355

Study Officials

• Robert CG Martin, MD, PhD

  University of Louisville

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor University of Louisville

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 10, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 25, 2018
• Results First Posted: June 7, 2018

Record last verified: 2018-03

Locations

US (3)