In short
Currently, there are 2 ongoing clinical trials investigating treatments for mesothelioma. These studies focus on evaluating the long-term safety of targeted cancer therapies and reducing side effects of standard chemotherapy treatments. Trials are being conducted in France, Poland, and the Netherlands.
Clinical trial locations
- France
- Netherlands
- Poland
Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials
This study evaluates the long-term safety of tazemetostat, a medication taken as film-coated tablets by mouth. The trial is designed for patients who have previously received tazemetostat in other clinical trials and have shown benefit from the treatment.
Inclusion criteria: Participants must be currently benefiting from tazemetostat treatment, either alone or in combination with other medications as part of a clinical trial. They must have a life expectancy of more than 3 months and adequate blood cell counts, bone marrow function, kidney function, and liver function. Women of childbearing potential must have a negative pregnancy test and agree to use both a highly effective birth control method and a barrier method during treatment and for 6 months afterward. Men must either have had a successful vasectomy or use condoms throughout the study and for 3 months after stopping treatment.
Exclusion criteria: Patients cannot participate if they are not currently receiving tazemetostat treatment in a previous study, have experienced severe side effects during previous treatment, have developed progressive disease while on tazemetostat, or are participating in other clinical trials simultaneously. Those who cannot comply with long-term safety monitoring requirements or have withdrawn consent from their previous study are also excluded.
Focus and goal: The study monitors patients who continue taking tazemetostat to track any side effects that may occur over an extended period. Researchers will monitor various health measures, including blood cell counts, kidney function, and liver function, as well as how long patients survive while receiving treatment. This is an open-label study, meaning all participants receive the active medication without a placebo comparison.
Investigational drug: Tazemetostat is an EZH2 inhibitor that works by blocking the EZH2 protein, which plays a crucial role in controlling gene expression and cancer cell growth. It represents an innovative approach in targeted cancer therapy and is being studied for its long-term safety profile.
Study on Calcium Folinate to Reduce Pemetrexed Side Effects in Patients with Non-Small Cell Lung Cancer, Mesothelioma, or Thymoma
This clinical trial investigates whether calcium folinate (in a medication called Rescuvolin) can help reduce side effects caused by pemetrexed, a chemotherapy treatment used for non-small cell lung cancer, mesothelioma, and thymoma. The study particularly focuses on preventing side effects affecting blood cells.
Inclusion criteria: Participants must be at least 18 years old and have non-small cell lung cancer, mesothelioma, or thymoma. They must be eligible for treatment with pemetrexed-based chemotherapy and have an ECOG performance score between 0 and 2. This score measures how well patients can perform daily activities, with 0 meaning fully active and 2 meaning able to be up and about more than half the day but unable to work. Patients must be able and willing to sign an informed consent form.
Exclusion criteria: Patients with any other type of cancer besides non-small cell lung cancer, mesothelioma, or thymoma cannot participate. Those who are part of a vulnerable population unable to give consent, have medical conditions that would make participation unsafe, or are currently participating in another clinical trial are also excluded.
Focus and goal: The study aims to evaluate whether calcium folinate can prevent or lessen side effects, particularly those affecting blood cells like neutropenia (low white blood cell count), when used alongside pemetrexed. Participants are randomly assigned to receive either calcium folinate or a placebo in addition to their regular cancer treatment. Health monitoring includes regular blood cell counts, with specific assessments on days 8-10 of treatment and after the second and fourth cycles to evaluate treatment efficacy.
Investigational drugs: The study uses two main drugs. Pemetrexed is a chemotherapy medication given through an intravenous infusion that interferes with cancer cells' ability to make and repair DNA, essential for their growth. Folinic acid (calcium folinate) is a form of vitamin B used as a "rescue therapy" to help protect healthy cells from the harmful effects of pemetrexed, with the goal of reducing the risk of neutropenia and other side effects.
Summary
The two ongoing clinical trials for mesothelioma reflect different approaches to improving patient care. One trial focuses on the long-term safety monitoring of a targeted therapy, tazemetostat, in patients who have already shown benefit from this treatment. The other trial investigates whether adding a protective vitamin supplement can reduce chemotherapy side effects.
Geographically, trials are distributed across Western and Central Europe, with France and Poland hosting the tazemetostat safety study and the Netherlands conducting the calcium folinate trial. The Dutch study is notable for including multiple cancer types alongside mesothelioma, specifically non-small cell lung cancer and thymoma.
Both studies represent important aspects of cancer care: establishing the safety profile of newer targeted therapies and improving the tolerability of established chemotherapy treatments. Patients interested in participating should discuss eligibility with their healthcare providers and consider the specific requirements and monitoring schedules of each trial.
