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Metastatic Malignant Neoplasm in the LiverPhase 2NCT04728633

Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases

A Phase 2 study testing Carmustine, Ethiodized Oil and Transarterial Chemoembolization in people with Metastatic Malignant Neoplasm in the Liver and Metastatic Uveal Melanoma, run by Thomas Jefferson University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carmustine, Ethiodized Oil and Transarterial Chemoembolization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
27 Sep 2021to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Chemoembolization of Uveal Melanoma Hepatic Metastases Using 300mg of BCNU Dissolved in Lipiodol® Followed by Gelfoam® Embolization

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.

Read the 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.

Being tested
Carmustine, Ethiodized Oil, Transarterial Chemoembolization, Medical Device Usage and Evaluation
Medical subject headings
Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarmustineDrug

    Also called 1,3-Bis(2-chloroethyl)-1-nitrosourea, 1,3-Bis(beta-chloroethyl)-1-nitrosourea, BCNU, Becenum

    Given via infusion

  • Ethiodized OilDrug

    Also called Lipiodol, Iodized Oil, Ethiodol, ETHIODIZED OIL,

    Given via infusion

  • Transarterial ChemoembolizationProcedure or surgery

    Also called TACE

    Undergo TACE

  • Medical Device Usage and EvaluationOther

    Given gelatin sponge via injection

Study groups in NCT04728633
Study groupRoleWhat they receive
Treatment (carmustine, ethiodized oil, gelatin sponge)ExperimentalPatients 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.
Receives: Drug: Carmustine; Drug: Ethiodized Oil; Procedure: Transarterial Chemoembolization; Other: Medical Device Usage and Evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best response to treatment

    Response to treatment

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

  2. 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.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Time to progression

    Will be estimated by the Kaplan-Meier method.

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

  2. Overall survival

    Will be estimated by the Kaplan-Meier method. Date and cause of death will be recorded. The cause of death will be categorized as either cancer-related or cancer unrelated.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2021
  2. Study start27 Sep 2021
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04728633
Sponsor's protocol ID
20P.1076
Other IDs
JT 15505
Status last verified
May 2026
First submitted
25 Jan 2021
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carmustine, Ethiodized Oil and Transarterial Chemoembolization in people with Metastatic Malignant Neoplasm in the Liver and Metastatic Uveal Melanoma, run by Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best response to treatment (time frame: After the completion of cycle 2 of chemoembolization (1 cycle = 4 or 7 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04728633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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