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Liver-Directed chemo shows promise for eye cancer metastases

NCT ID NCT04728633

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a procedure called transarterial chemoembolization (TACE) for people with uveal melanoma that has spread to the liver. Doctors inject a chemotherapy drug (carmustine) mixed with an oily contrast agent (Lipiodol) directly into the liver's blood supply, then block the artery with a gelatin sponge. The goal is to shrink or control liver tumors. The study enrolled 28 participants and is no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
carmustine (BCNU) chemotherapy combined with ethiodized oil (Lipiodol) and gelatin sponge
What this could lead to
If it works, this could offer a way to control liver tumors in uveal melanoma that has spread, potentially extending survival.
What could go wrong
This is a small phase 2 trial with only 28 participants, so results may not apply broadly. Chemoembolization carries risks like liver damage and side effects from chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

28 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.