Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases

NCT ID: NCT04728633

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2027-06-30

Brief Summary

This phase II trial studies the effect of transarterial chemoembolization in treating patients with uveal melanoma that has spread to the liver (liver metastases). Transarterial chemoembolization involves the injection of a blocking agent (gelatin sponge, ethiodized oil) and a chemotherapy agent (carmustine) directly into the artery in the liver to treat liver cancers. Chemotherapy drugs, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. transarterial chemoembolization with carmustine in combination with ethiodized oil and gelatin sponge may help cause the tumors in the liver to shrink or disappear.

Detailed Description

PRIMARY OBJECTIVE:

To determine the efficacy (clinical response) in terms of disease control rate (DCR) (complete response [CR] + partial response [PR] + stable disease [SD]) with chemoembolization of hepatic metastases with 300 mg of carmustine (BCNU) in ethiodized oil in metastatic uveal melanoma patients.

SECONDARY OBJECTIVES:

To investigate overall survival (OS) and progression-free survival (PFS) in uveal melanoma patients with hepatic metastases.

To assess the toxicity of the above treatment regimen.

OUTLINE:

Patients undergo transarterial chemoembolization (TACE) by receiving an infusion of carmustine dissolved in ethiodized oil and an injection of gelatin sponge. Treatment repeats once every 4 weeks (Q4W) for bilobar disease or once every 7 weeks (Q7W) for unilobar disease in the absence of disease progression or unacceptable toxicity or until maximum clinical benefit is obtained.

Steroid taper will begin the day of patient discharge. After completion of study treatment, patients are followed up at 30 days, and then every 2 months for up to 2 years.

After 3 years from first treatment, follow-up scans may occur every 16-20 weeks and labs every other month.

Conditions

Metastatic Malignant Neoplasm in the Liver; Metastatic Uveal Melanoma; Stage IV Choroidal and Ciliary Body Melanoma AJCC V8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (carmustine, ethiodized oil, gelatin sponge)

Patients undergo TACE by receiving an infusion of carmustine dissolved in ethiodized oil and an injection of gelatin sponge. Treatment repeats Q4W for bilobar disease or Q7W for unilobar disease in the absence of disease progression or unacceptable toxicity or until maximum clinical benefit is obtained.

Group Type: EXPERIMENTAL

Carmustine

Intervention Type: DRUG

Given via infusion

Ethiodized Oil

Intervention Type: DRUG

Given via infusion

Transarterial Chemoembolization

Intervention Type: PROCEDURE

Undergo TACE

Medical Device Usage and Evaluation

Intervention Type: OTHER

Given gelatin sponge via injection

Interventions

Carmustine

Given via infusion

Intervention Type: DRUG

Ethiodized Oil

Given via infusion

Intervention Type: DRUG

Transarterial Chemoembolization

Undergo TACE

Intervention Type: PROCEDURE

Medical Device Usage and Evaluation

Given gelatin sponge via injection

Intervention Type: OTHER

Other Intervention Names

1,3-Bis(2-chloroethyl)-1-nitrosourea; 1,3-Bis(beta-chloroethyl)-1-nitrosourea; BCNU; Becenum; Becenun; BiCNU; Bis(chloroethyl) Nitrosourea; Bis-Chloronitrosourea; Carmubris; WR-139021; SRI 1720; SK 27702; Nitrumon; Nitrourean; N,N''-Bis(2-chloroethyl)-N-nitrosourea; FDA 0345; Carmustinum; Carmustin; steroid taper initiated on day of discharge; Lipiodol; Iodized Oil; Ethiodol; ETHIODIZED OIL,; 8008-53-5; TACE

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed metastatic uveal melanoma in the liver
• Tumor burden < 75%. Patients must have at least one tumor measuring >= 10 mm in longest diameter by magnetic resonance imaging (MRI) or triphasic computed tomography (CT) (if MRI is not available or contraindicated)
• No prior transarterial catheter-directed therapies. Prior hepatic tumor ablation, hepatic radiation or liver resection will be permitted as long as growing measurable liver tumors exists. Prior systemic treatments are allowed as long as there are no outstanding toxicities greater than grade 1
• Willingness and ability to give informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Serum creatinine =< 2.0 mg/dl
• Bilirubin =< 2.0 mg/ml. Exceptions will be made for patients with diagnosed Gilbert's Syndrome. In this instance, a bilirubin level =< 3.0 mg/ml will be allowed for this patients with this syndrome
• Albumin >= 3.0 g/dl
• No ascites
• Granulocyte count >= 1500/m^3
• Platelet count >= 150,000/m^3

Exclusion Criteria

• Less than 18 years of age
• Previous liver-directed treatments including immunoembolization, chemoembolization, radioembolization, hepatic arterial perfusion, or drug-eluting beads
• Presence of life-limiting extrahepatic metastasis that requires systemic treatment within 3 months. However, radiation treatment of extrahepatic metastases such as bone, lymph nodes or subcutaneous metastases will be permitted while the patient is on study. Zometa or X-Geva to treat bone metastases will also be permitted. Immune check-point inhibitors while on study will NOT be permitted
• Portal vein occlusion, or inadequate collateral portal venous flow, as determined by MRI
• Known active viral or autoimmune hepatitis requiring treatments with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) equal or greater than 5 times normal
• Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry
• Presence of any other medical conditions that imply a survival of less than six months
• Uncontrolled severe bleeding tendency or active gastrointestinal (GI) bleeding due to varices or main portal vein occlusion. Abnormal coagulation test must be corrected prior to the procedure
• History of life-threatening allergic reaction to iodinated contrast or BCNU despite pre-treatment with steroids
• Pregnant and/or breastfeeding women
• Presence of known untreated brain metastases. If patients have had previous treatment for brain metastasis, an MRI or CT of the brain must confirm the stabilization of the brain metastasis for more than 4 weeks
• Biliary obstruction, biliary stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carin Gonsalves, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 15505

Identifier Type: OTHER

Identifier Source: secondary_id

20P.1076

Identifier Type: -

Identifier Source: org_study_id