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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

NCT01010984•Robert C. Martin

View on ClinicalTrials.gov

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.

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Exclusion Criteria

•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
•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
+10 more criteria

Locations (3)

University of Louisville

Louisville, Kentucky, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 1, 2009

Primary Completion Date

December 1, 2012

Completion Date

December 1, 2012

Last Updated

October 25, 2018

Enrollment

ACTUAL participants

Conditions

Stage IV Melanoma

Interventions

LC beads loaded with Doxorubicin

DEVICE

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

NCT05176470

Locally Advanced MelanomaPathologic Stage IIIB Cutaneous Melanoma AJCC v8+3 more

View study

WITHDRAWNPHASE1

Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases

NCT02145910

Recurrent MelanomaStage IV Melanoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases

A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma

flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer

Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma

Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma