What side effects are associated with this type of intervention?

Transarterial chemoembolization (TACE) for uveal melanoma, which involves localized delivery of carmustine combined with blocking agents, can lead to several side effects. Commonly reported adverse effects include retinal toxicity, such as optic disc edema, pallor, and retinopathy, which can result in irreversible optic nerve damage and vision loss. Additionally, patients may experience sectoral choroidal occlusive vasculopathy and retinal arteriolar embolization. These side effects highlight the importance of close monitoring and potential discontinuation of therapy if severe ocular toxicity occurs.

What prior FDA approvals exist?

The FDA has approved several treatments for Uveal Melanoma, though specific approvals for localized delivery methods like Transarterial Chemoembolization are less common. Traditional treatments include systemic chemotherapy, immunotherapy, and targeted therapies. For instance, carmustine, a chemotherapy agent used in the trial for Transarterial Chemoembolization, is approved for various cancers but not specifically for Uveal Melanoma. The use of blocking agents to restrict blood flow to tumors is a technique more commonly seen in liver cancer treatments. Overall, while localized delivery methods are being studied, broader systemic treatments remain the primary FDA-approved options for Uveal Melanoma.

What other types of research exist?

Promising novel alternatives to Transarterial Chemoembolization for Uveal Melanoma patients include: 1) Anti-VEGF agents such as Ranibizumab (Lucentis), which inhibit vascular endothelial growth factor to reduce neovascularization and tumor growth. 2) Nanoscale delivery systems that enhance the delivery of therapeutic agents to the posterior eye, potentially improving treatment efficacy and reducing the frequency of administration. 3) Intravitreal and subconjunctival administration of chemotherapeutic agents like melphalan, which have shown significant tumor reduction in preclinical studies.

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Alkylating agents

Chemoembolization for Liver Cancer

Phase 2

Recruiting

Led By Carin Gonsalves, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Previous liver-directed treatments including immunoembolization, chemoembolization, radioembolization, hepatic arterial perfusion, or drug-eluting beads

Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 5 Other Conditions

Summary

This trial studies a treatment that injects chemotherapy and blocking agents into the liver's blood vessels to target tumors in patients with eye cancer that has spread to the liver. The goal is to cut off the tumor's blood supply and apply chemotherapy directly, helping to shrink or eliminate the tumors. This method delivers highly concentrated drugs to the tumor and stops blood flow to it.

Who is the study for?

This trial is for adults with uveal melanoma that has spread to the liver. Participants must be able to consent, have good kidney function and physical health, a certain level of blood cells and albumin, and tumors detectable by imaging. They can't join if they're under 18, pregnant or breastfeeding, have had certain previous liver treatments or surgeries, uncontrolled other diseases like heart failure or hepatitis, severe bleeding tendencies or life-threatening allergies to specific drugs.

What is being tested?

The study tests transarterial chemoembolization on liver metastases from uveal melanoma. It involves injecting carmustine (chemotherapy) combined with ethiodized oil and gelatin sponge directly into the liver artery to shrink or eliminate tumors.

What are the potential side effects?

Potential side effects may include pain at the injection site, fever post-procedure (post-embolization syndrome), changes in liver function tests, fatigue due to chemotherapy drug carmustine as well as possible allergic reactions to any of the substances used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer, which started in the eye, has spread to my liver.

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My tumor is less than 75% of my organ's size and at least one tumor is 10 mm or larger.

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I am fully active or can carry out light work.

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I do not have fluid buildup in my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments targeting my liver.

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I do not have uncontrolled high blood pressure, heart failure, or a recent heart attack.

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I have hepatitis with liver enzyme levels more than 5 times the normal.

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I have had surgery or a procedure on my bile ducts, but not gallbladder removal.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best response to treatment

Disease control rate (DCR) including complete response + partial response + stable disease

Secondary study objectives

Incidence of adverse events

Overall survival

Time to progression

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carmustine, ethiodized oil, gelatin sponge)Experimental Treatment4 Interventions

Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carmustine

FDA approved

Transarterial Chemoembolization

2009

Completed Phase 1

~100

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Uveal Melanoma, such as Transarterial Chemoembolization (TACE), involve the localized delivery of chemotherapy agents like carmustine directly into the artery supplying the tumor. This is combined with blocking agents (e.g., gelatin sponge, ethiodized oil) to restrict blood flow to the tumor, enhancing the concentration of the drug at the tumor site and starving the tumor of nutrients. This targeted approach is crucial for Uveal Melanoma patients as it maximizes the tumor-killing effects while minimizing systemic side effects, potentially leading to better treatment outcomes and quality of life.

Intravitreal and subconjunctival melphalan for retinoblastoma in transgenic mice.Occurrence of sectoral choroidal occlusive vasculopathy and retinal arteriolar embolization after superselective ophthalmic artery chemotherapy for advanced intraocular retinoblastoma.