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Study on Colchicine and Tiemonium Methylsulphate for Reducing Atherosclerosis in Cancer Patients Undergoing Immune Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication colchicine on patients with atherosclerosis who are also receiving treatment for cancer with immune therapy. Atherosclerosis is a condition where the blood vessels become narrowed and hardened due to a buildup of plaque, which can lead to heart problems. The study aims to see if colchicine can help reduce inflammation in the blood vessels of these patients.

Participants in the study will receive colchicine, which is taken orally, to see if it can help manage the inflammation in their coronary arteries, which are the blood vessels that supply the heart. The study will also involve the use of a special type of scan called a PET-scan to measure changes in the blood vessels over a period of 12 weeks. This scan helps to visualize how much of a certain substance, called 68Gallium-DOTATATE, is taken up by the blood vessels, which indicates the level of inflammation.

The trial will also monitor other health indicators, such as the condition of the carotid arteries and aorta, which are major blood vessels, as well as the overall health of the spleen and bone marrow. Additionally, the study will track any major heart-related events, like heart attacks or strokes, and any side effects related to the immune therapy. The goal is to understand if colchicine can provide a protective effect for patients undergoing cancer treatment, potentially improving their overall health outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, eligibility is confirmed based on criteria such as being 50 years or older, having signs of atherosclerosis on imaging, and planning to receive a PD-1 or PD-L1 inhibitor for at least 3 months.
Step 2
Initial assessment
An initial assessment is conducted, which includes imaging tests to measure the coronary artery calcium score and other relevant health markers.
Step 3
Medication administration
The medication colchicine is administered orally. The specific dosage and frequency are determined by the trial protocol and communicated during this stage.
Step 4
Ongoing monitoring
Regular monitoring is conducted to assess the effect of colchicine on coronary vessel wall inflammation. This includes follow-up imaging and blood tests to measure various health markers.
Step 5
12-week follow-up
A follow-up assessment is conducted 12 weeks after starting the medication. This includes a PET-scan to measure changes in the target-to-background ratio (TBRmax) in coronary arteries.
Step 6
Completion of trial participation
Upon completion of the trial, final assessments are conducted to evaluate the overall impact of the treatment. This includes reviewing any changes in health markers and recording any adverse events experienced during the trial.

Who can join the trial?

3 criteria

Must be 50 years or older.
Must be planned for treatment with a PD-1 or PD-L1 inhibitor for at least 3 months. These are types of medications used in cancer treatment.
Must show signs of atherosclerosis on imaging tests. This means there should be evidence of calcium deposits in the arteries, which can be seen on certain types of CT scans.

Who cannot join the trial?

2 criteria

Patients with **Atherosclerosis** cannot participate. Atherosclerosis is a condition where the blood vessels become narrow due to the buildup of fats, cholesterol, and other substances.
Patients with **Cancer** are not eligible. Cancer is a disease where some of the body's cells grow uncontrollably and spread to other parts of the body.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Colchicine is a medication that is being studied for its potential to reduce inflammation in the walls of the coronary vessels. In this trial, researchers are investigating whether colchicine can help prevent or slow down the development of atherosclerosis, which is a condition where the arteries become narrowed and hardened due to a buildup of plaque. This condition can be accelerated by certain cancer treatments known as immune checkpoint inhibitors. By reducing inflammation, colchicine may help protect the heart and blood vessels in patients undergoing these cancer treatments.

What is already known about the treatment

Colchicine – Colchicine is administered orally in the form of tablets. It is currently being studied in clinical trials to assess its potential benefits in reducing inflammation in the coronary vessels, particularly in patients with cancer who are experiencing accelerated atherosclerosis due to immune checkpoint inhibitors. The main therapeutic indications for colchicine include its use in treating conditions like gout and familial Mediterranean fever, but it is now being explored for its anti-inflammatory effects in cardiovascular diseases. At the molecular level, colchicine works by disrupting the formation of microtubules, which are structures within cells that help with cell division and transport, thereby reducing inflammation. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Atherosclerosis
Atherosclerosis is a condition where the arteries become narrowed and hardened due to a buildup of plaque on the artery walls. This plaque is made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, the plaque can harden and narrow the arteries, limiting the flow of oxygen-rich blood to organs and other parts of the body. As the disease progresses, it can lead to reduced blood flow, which may cause symptoms like chest pain or leg pain during physical activity. In advanced stages, atherosclerosis can lead to serious complications if the plaque ruptures, potentially causing blood clots. The progression of the disease is gradual and can occur over many years.
Cancer
Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells can invade and destroy normal body tissue, and they have the potential to spread throughout the body. The progression of cancer varies depending on the type and location of the cancer, as well as the individual characteristics of the patient. In general, cancer begins when genetic changes interfere with the normal regulation of cell growth and division. As cancer progresses, it can form tumors, invade nearby tissues, and spread to other parts of the body through the bloodstream or lymphatic system. The rate of progression can vary widely, with some cancers growing slowly and others advancing rapidly.