Metastatic melanoma to the liver: a clinical trial

Metastatic melanoma to the liver clinical trial: an introduction.

Do you have melanoma that has spread to your liver? Your doctor may refer to this as ‘metastatic melanoma to the liver’.

If you do – and the cancer in your liver is currently untreatable with surgery - you may be able to join this medical research study.

The study’s purpose is to test the safety and effectiveness of a ‘study device’. It’s hoped this study device might help kill liver tumors in people with your condition.

Why is it called a ‘study device’? Because it hasn’t been approved by the Food and Drug Administration (FDA) as a treatment for metastatic melanoma to the liver.

The study device consists of thousands of tiny round beads which together are known as ‘LC Bead’. LC Bead is coated with a chemotherapy drug called doxorubicin.  All 20 people who participate in this trial will have LC Bead inserted in their liver.

Are you eligible?

To join this study, at least 50% of the cancer in your body must be in your liver. Physicians call this ‘liver dominant metastatic melanoma’.

The study is open to people across the United States. But you’ll need to make several trips to Louisville, Kentucky.

The study device explained

How does LC Bead loaded with doxorubicin work? Firstly, the beads are inserted into the blood vessels in your liver that feed your tumor. This is what we call a minimally invasive procedure, since it is done through a blood vessel in the groin and does not involve open surgery.

Once in place, the beads act in two ways. Firstly, they stop blood flowing to your tumor. Researchers hope that this blockage may help to kill it. Secondly, the beads release the doxorubicin directly into the tumor. It’s hoped this will further assist in your tumor’s death.

Importantly, researchers expect the doxorubicin to be contained within your tumor and the area immediately around it. If this targeted approach works, there will be two benefits.

First of all, it will stop the doxorubicin harming healthy liver tissue and other areas of your body. That may mean fewer doxorubicin-related side effects like hair falling out. In turn, this will allow stronger doses of doxorubicin to be given than is possible when given to the whole body.

Physicians call this targeted delivery of a chemotherapy drug ‘chemoembolization’ or ‘TACE’ (Trans Arterial Chemo Embolization).

LC Bead and doxorubicin approved for other uses

As mentioned earlier, the study device doesn’t have FDA approval as a treatment for metastatic melanoma to the liver. However, the LC Bead without doxorubicin is an approved treatment. In particular, it is approved as a means of blocking blood vessels that supply blood to tumours in the liver.

Meanwhile, doxorubicin – without LC Bead – is approved by the FDA as a treatment for ovarian cancer, multiple myeloma and AIDS-related Kaposi sarcoma among other conditions.

Your standard treatment isn’t affected

If you join this study, you’ll continue receiving your standard medical treatment. This will be managed and delivered by your existing Medical Oncologist.

Importantly, your Medical Oncologist will be kept fully informed of the study-related procedures you undergo. And how you respond to them.

You can leave at any time

Participation in this study is voluntary. That means you’re free to withdraw without having to give a reason. Doing so will not affect your standard medical treatment for metastatic melanoma to the liver in any way.

Metastatic melanoma to the liver clinical trial: what participation entails

If this metastatic melanoma to the liver clinical trial interests you, it’s important you understand what’s involved before deciding to join. To build this understanding, you’ll obviously need to discuss the trial with the healthcare professionals who’re running it. And ideally with your Medical Oncologist, friends and family.

Your first conversation with the clinical trial team will be on the phone. Then, if you and they wish to continue the discussion, you’ll attend a face-to-face meeting. This will be with the physician running the clinical trial. Also at the meeting will be the Research Coordinator. This person manages the clinical trial on a day-to-day basis.

These conversations will allow you to fully understand how the trial works. And they’ll allow the research team to find out whether you might be eligible to participate.

The Informed Consent Document

If, after these conversations, you’re still interested in joining, you’ll be invited to read a so-called ‘Informed Consent Document’. This explains the study in detail. And it’s written in a style that’s easy to understand.

Once you’ve understood the Informed Consent Document, you must sign it if you still wish to participate. If you do this, you’ll move to the next stage, known as ‘screening’.

How you’ll be screened

The screening process involves tests to check whether you’re eligible to join the clinical trial. And whether you’re healthy enough to participate.

These include blood tests, CT scans to measure your tumors and a MUGA scan to test your heart function. Each of these can take several hours of your time.

If you pass the screening tests, you’ll be enrolled in the clinical trial. You’ll receive your first injection of LC Bead loaded with doxorubicin within four weeks.

The bead injection procedure

The procedure to inject the LC Bead is minimally invasive. In fact, you remain awake throughout. At the start of the procedure, you’ll be given pain medication and sedatives.

Next, a small flexible tube will be inserted into the artery in your groin. This tube is called a catheter and is about the size of a piece of spaghetti.

The catheter will be guided towards the blood vessels in your liver that feed your tumor. This is done using X-ray equipment. Once the catheter is in place, the LC Bead is injected through it and out into the target blood vessels.

After the procedure, you’ll stay in hospital for observation for up to 23 hours.

Two to three weeks after receiving your first injection of beads, you’ll receive another. If only one side of the liver has cancer, the beads will be injected into that area again. Meanwhile, where both left and right halves have cancer, the next bead injection will be into the opposite side. The procedure is the same.

In total, you’ll receive two to three injections into each affected area of the liver. Therefore, you could have up to six injections if you have tumors throughout the liver.

Your standard treatment continues

In the weeks when you’re not receiving the beads, you’ll receive your standard chemotherapy treatment. This will be managed and delivered by your existing Medical Oncologist.

Meanwhile, you’ll undergo medical tests throughout the trial. These will include CT scans, blood tests and evaluations of your vital signs. The tests will reveal how your body is responding to the LC Bead loaded with doxorubicin. And show whether you’re healthy enough to stay in the clinical trial.

What happens once all your bead injections are complete? You’ll be monitored in the study for a further two years.

Meanwhile, the beads don’t need to be taken out. As a result, they’ll stay in your body permanently.

Metastatic melanoma to the liver clinical trial: potential risks.

What risks might you face by participating in this metastatic melanoma to the liver clinical trial?

First of all, it’s possible your metastatic melanoma to the liver may not get better. Or it could become worse.

Also, there are a variety of other potential risks you need to consider before deciding to participate. Each of these will be explained to you by the research team. They’re also explained in the Informed Consent Document.

So which ones are you most likely to experience?

Firstly, doxorubicin chemotherapy can be associated with unwanted symptoms. These include:

• Feeling or being sick
• Fatigue
• Loss of appetite
• Diarrhoea
• Difficulty swallowing
• Thin or brittle hair
• Irritated skin
• Low blood counts
• Blisters in the mouth
• Swelling, pain, redness or peeling of the skin on the palms and soles of the feet.

It’s important to note that many of these can be managed using other medications. For example, antacids and anti-vomit drugs.

Besides side effects, the trial also involves procedures that give rise to a variety of risks. For example, you might experience pain where the catheter is inserted. And the blood draws may cause you some discomfort.

There are also risks associated with some of the technologies used in the study. For example, x-rays and CT scans.

While the above are known risks, there may also be risks that are unknown or unforeseeable.

Metastatic melanoma to the liver clinical trial: potential benefits.

This metastatic melanoma to the liver clinical trial could potentially deliver several benefits.

Firstly, it’s possible that receiving the study device may help shrink your tumor or tumors. This might prolong your survival. However, this is not certain.

Another reason to think about joining this trial is to advance medical knowledge. By volunteering, you’ll help researchers find better treatments for melanoma that has metastasised to the liver.

Metastatic melanoma to the liver clinical trial: costs of participation

If you’re interested in participating in this metastatic melanoma to the liver clinical trial, it’s essential that you first understand the financial consequences of doing so.

Importantly, you and your insurance company will be billed for all of the standard of care (i.e. routine) costs of treating you in this medical research study.

Examples include doctor’s office visits, blood tests, x-rays, CT scans and EKGs that would be done even if you weren’t participating in this study.

You will be responsible for paying your co-pay that is associated with any procedures.

None of the charges from the doctor’s office or hospital during your participation in this study will be paid for by the research program.

Importantly, some insurance companies won’t cover treatment costs for people who participate in a research study. Therefore, you should ask your insurance company what they will pay before participating in this clinical trial. If needed, a study staff member may be able to help you do this.

If your insurance company does not pay for your bills associated with this study, you will be responsible for paying them if you decide to go ahead.

You will not be billed for the tests and procedures that are only done for this clinical trial and that would not be necessary if you were not taking part. The charges for these items will be paid for by the research program. Items you will not be billed for include the LC Bead and the MUGA scans.           

Please be aware that if you’re injured by the research, you may incur additional costs for participating in this metastatic melanoma to the liver clinical trial.