Liver-Directed chemo shows promise for eye cancer metastases
NCT ID NCT04728633
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
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, 19107, United States
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Other studies related to the condition(s) this trial covers.
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