Study on Transarterial Chemoembolization for Treating Uveal Melanoma with Liver Metastases

Sponsor: Thomas Jefferson University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04728633

Provider View

This clinical trial is exploring a treatment called transarterial chemoembolization for patients with uveal melanoma that has spread to the liver. The treatment involves delivering chemotherapy directly to the liver to help shrink or eliminate tumors.

Patient Parameters

Program Overview

This study is testing a treatment called transarterial chemoembolization for patients with uveal melanoma that has spread to the liver. This treatment involves injecting a chemotherapy drug, carmustine, along with a blocking agent directly into the liver's artery. The goal is to stop the growth of cancer cells and shrink or eliminate the tumors in the liver.

Description

The main goal of this study is to see how well the treatment controls the cancer in the liver by measuring the disease control rate, which includes complete response, partial response, and stable disease. Researchers will also look at how long patients live and how long they stay free from cancer progression. They will assess any side effects from the treatment.

Patients will receive the treatment through a procedure called transarterial chemoembolization (TACE), where carmustine is mixed with a special oil and injected into the liver, along with a gelatin sponge. This treatment is repeated every 4 weeks for cancer in both liver lobes or every 7 weeks for cancer in one lobe, as long as the cancer does not progress or side effects are manageable.

After finishing the treatment, patients will have follow-up visits 30 days later and then every 2 months for up to 2 years to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with uveal melanoma that has spread to the liver.
  • Tumor size less than 75% of the liver, with at least one tumor measuring 10 mm or more.
  • No previous treatments directed at the liver using a catheter.
  • Willing and able to provide informed consent.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Kidney function with serum creatinine 2.0 mg/dl or less.
  • Bilirubin level 2.0 mg/ml or less, with exceptions for Gilbert's Syndrome up to 3.0 mg/ml.
  • Albumin level of 3.0 g/dl or higher.
  • No fluid buildup in the abdomen (ascites).
  • Granulocyte count of 1500/m^3 or higher.
  • Platelet count of 150,000/m^3 or higher.

Exclusion Criteria

  • Under 18 years old.
  • Previous liver-directed treatments like chemoembolization or radioembolization.
  • Life-threatening cancer outside the liver needing treatment within 3 months.
  • Blocked portal vein or poor blood flow in the liver.
  • Active hepatitis or liver inflammation with high liver enzymes.
  • Uncontrolled high blood pressure, heart failure, or recent heart attack.
  • Medical conditions suggesting less than six months to live.
  • Severe bleeding issues or active bleeding in the digestive system.
  • Severe allergic reaction to contrast dye or carmustine.
  • Pregnant or breastfeeding women.
  • Untreated brain cancer or unstable brain metastases.
  • Bile duct blockage or previous bile duct surgery.

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