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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01010984
• Date of registration: 04/11/2009
• Prospective Registration: No
• Primary sponsor: Robert C. Martin
• Public title: LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma DEBDOX
• Scientific title: Transcatheter Arterial Chemoembolization With Doxorubicin-loaded LC Beads in the Treatment of Liver-dominant Metastases in Patients With Stage IV Metastatic Melanoma
• Date of first enrolment: September 2009
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01010984
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Robert CG Martin, MD, PhD
• Affiliation: University of Louisville

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stage IV Melanoma

Intervention(s)

Device: LC beads loaded with Doxorubicin

Primary Outcome(s)

Incidence of Adverse Events [Time Frame: Date of surgery through 2 years post procedure or until patient death]

Secondary Outcome(s)

Percentage of Tumor Response [Time Frame: Percentage of tumor response assessed up to 1 year post treatment.]

Secondary ID(s)

G090097

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Louisville

M.D. Anderson Cancer Center

Thomas Jefferson University

Results

• Results available: Yes
• Date Posted: 07/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01010984