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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Stage IV Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcatheter Arterial Chemoembolization

TACE using LC beads loaded with Doxorubicin

Group Type EXPERIMENTAL

LC beads loaded with Doxorubicin

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No