Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases

NCT04728633 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20P.1076JT 15505
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Best response to treatment

  Response to treatment

  After the completion of cycle 2 of chemoembolization (1 cycle = 4 or 7 weeks)

• Disease control rate (DCR) including complete response + partial response + stable disease

  All estimates of rates (e.g., DCR) will be presented with corresponding confidence intervals. For DCR, the method of Atkinson and Brown will be used to allow for the two-stage design using the criteria adapted from the international criteria proposed by Response Evaluation Criteria in Solid Tumors 1.03.

  Up to 2 years

Secondary Outcomes (2)

• Time to progression

  From the first chemoembolization to the time when progression of liver metastases is confirmed, assessed up to 2 years

• Overall survival

  From the first chemoembolization until death, assessed up to 2 years

Study Arms (1)

Treatment (carmustine, ethiodized oil, gelatin sponge)

EXPERIMENTAL

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.

Drug: Carmustine; Drug: Ethiodized Oil; Procedure: Transarterial Chemoembolization; Other: Medical Device Usage and Evaluation

Interventions

Medical Device Usage and Evaluation OTHER

Given gelatin sponge via injection

Treatment (carmustine, ethiodized oil, gelatin sponge)

Transarterial Chemoembolization PROCEDURE

Undergo TACE

Also known as: TACE

Treatment (carmustine, ethiodized oil, gelatin sponge)

Carmustine DRUG

Given via infusion

Also known as: 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

Treatment (carmustine, ethiodized oil, gelatin sponge)

Ethiodized Oil DRUG

Given via infusion

Also known as: Lipiodol, Iodized Oil, Ethiodol, ETHIODIZED OIL,, 8008-53-5

Treatment (carmustine, ethiodized oil, gelatin sponge)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Carmustine; Ethiodized Oil; Iodized Oil

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Carin Gonsalves, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)