Clinical trial NCT01010984: LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
Official title: Transcatheter Arterial Chemoembolization With Doxorubicin-loaded LC Beads in the Treatment of Liver-dominant Metastases in Patients With Stage IV Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage IV Melanoma
Keywords: metastatic melanoma
stage IV melanoma
metastatic melanoma to the liver
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: University of Louisville
name: Thomas Jefferson University
name: M.D. Anderson Cancer Center
First posted: 2009-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Date of surgery through 2 years post procedure or until patient death
Secondary outcomes:
measure: Percentage of Tumor Response
timeFrame: Percentage of tumor response assessed up to 1 year post treatment.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Louisville
name: Robert CG Martin, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.