Overview

Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases

Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Thomas Jefferson University
Treatments:
Carmustine
Ethiodized Oil
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