Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

INTERACT MESO: Intraperitoneal Paclitaxel for Patients with Primary Malignant Peritoneal Mesothelioma – a Phase I/II Dose Escalation and Safety Study

The INTERACT MESO study is exploring a new approach for people with primary malignant peritoneal mesothelioma, a type of cancer that affects the lining of the abdomen. This is a Phase I/II study, which means it's one of the first human trials. It aims to find the safest and most effective dose of a medicine called paclitaxel, which will be given directly into the tummy area (intraperitoneal). Researchers are carefully watching participants to make sure the treatment is safe and to see how their bodies respond. This kind of research is vital for finding better ways to treat cancer in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

08 Oct 2024

Patients with malignant peritoneal mesothelioma

What is this study about?

This study, called INTERACT MESO, is focused on a specific type of cancer called malignant peritoneal mesothelioma. This cancer starts in the lining of your tummy area (abdomen). The researchers are looking at a new way to give a common cancer medicine called paclitaxel. Instead of giving it through a drip in your vein, they are giving it directly into the tummy area where the cancer is. This is hoped to make the medicine work better by getting it right to where it's needed.

This is an early-stage study, known as a Phase I/II trial. In Phase I, the main goal is to find the safest dose of the medicine and understand any side effects. Once a safe dose is found, Phase II will look more closely at how effective the treatment is. This careful step-by-step approach is standard in medical research to ensure new treatments are safe before they are used more widely.

The reason this study matters is that malignant peritoneal mesothelioma can be challenging to treat. By exploring new ways to deliver existing medicines, doctors hope to find more effective and targeted treatments for patients. Studies like INTERACT MESO are crucial for advancing our understanding of cancer and developing better options for care.

Key takeaways

This study is for a type of cancer in the tummy lining.
It's testing a new way to give a cancer medicine directly into the tummy.
The main goals are to find a safe dose and see how well it works.
Anyone 18 or over with this type of cancer may be able to join.
You'll have regular check-ups and close monitoring.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults who have been diagnosed with malignant peritoneal mesothelioma, which is a type of cancer in the lining of the tummy.

To join, you must be 18 years old or older. The study is open to both men and women. There might be other specific health requirements that your doctor will check to make sure the study is a safe and suitable option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with malignant peritoneal mesothelioma?
Am I 18 years old or older?
Am I willing to consider a treatment given directly into my tummy area?
Am I able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, paclitaxel, directly into your tummy area. You would have regular appointments for check-ups, which include various tests to monitor your health and how you are responding to the treatment. These tests help the doctors understand if the medicine is working and if there are any side effects.

The study will involve several visits to the hospital or clinic for treatment and assessments. The healthcare team will explain the exact schedule of visits and tests during an initial meeting. You will be monitored closely for a period after your treatment finishes to see how you are doing.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new treatment approach that could help with your condition, and you'd be closely monitored by a healthcare team. However, there are also potential risks, as the treatment may have side effects, and it's not guaranteed to work. The doctors will fully explain all known and possible side effects. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is 'malignant peritoneal mesothelioma'?

It's a rare type of cancer that starts in the lining of your tummy (abdomen).

What does 'intraperitoneal' mean?

It means the medicine is given directly into the space inside your tummy, rather than through a vein.

What is a 'Phase I/II study'?

It's an early-stage study to find the safest dose of a new treatment and then to see how well it works.

Is paclitaxel a new medicine?

Paclitaxel is a common cancer medicine, but in this study, doctors are testing a new way of giving it (directly into the tummy).

Do I have to pay to be in the study?

No, all treatments and tests directly related to the study are usually provided free of charge.