01. Overview of Clinical Trials
What Is a Clinical Trial?
Clinical trials are medical studies involving people. These medical studies investigate and help improve several aspects of mesothelioma cancer:
- Diagnosis: Researchers test new technologies for making it faster and/or easier to diagnose mesothelioma.
- Treatment options: Doctors try new treatments to determine their safety and efficacy, sometimes leading to medical breakthroughs.
- Quality of life: Researchers determine whether new interventions can improve the standard of living for mesothelioma patients.
Clinical trials are highly regulated in order to ensure patient safety as well as the integrity of results. Researchers must follow stringent regulations enforced by the federal government.
Each study is also subject to an Institutional Review Board (IRB). The IRB is composed of doctors, scientists and other people who work to ensure the safety of each trial participant. The IRB does so by regularly reviewing the study and corresponding results. Each review is an opportunity for the IRB to ensure any risks are as low as possible.
Finding Clinical Trials for Mesothelioma
Patients can discuss clinical trials with their medical care team. An experienced mesothelioma doctor will know which trials are recruiting. They will also know which may be the most appropriate for the patient’s case.
Patients can also research clinical trials on their own. There are a variety of online resources that provide clinical trial information, including:
- National Cancer Institute (all NCI-approved clinical trials)
- ClinicalTrials.gov (database of worldwide clinical trials)
- Specific cancer center websites (e.g., The University of Texas MD Anderson Cancer Center’s Clinical Trials page)
Such resources often list the status of the clinical trial for patients to identify if they’re recruiting, in progress or closed. If recruiting or active, patients can ask their doctor about their eligibility for the trial.
Resources for Mesothelioma Patients
02. The Clinical Trial Experience
What Happens When You Participate in a Clinical Trial?
Once a patient decides to pursue clinical trial enrollment, they must first officially join the trial. Officially joining a clinical trial requires the following:
- Meeting all eligibility criteria: The patient must have all the characteristics required for participants. They must also not have any of the exclusionary characteristics. Common eligibility requirements include a specific stage of mesothelioma and activity level (performance status).
- Providing informed consent: All clinical trial patients must understand the details and risks of the trial. This information will be provided in writing. Study organizers will get a signed confirmation that the patient has received and understands the study information. This confirmation will also include consent by the patient to be treated according to the study protocol. If the patient is uncomfortable with any details from the informed consent, they can decline to participate in the trial.
- Undergoing preliminary tests and medical history: Many clinical trials start with doctors running blood or imaging tests on study patients. These tests provide baseline information that helps researchers understand the study results. Patients will also provide a medical history and may undergo a physical examination. These steps help ensure patient safety.
- Receiving treatment according to the study protocol: The patient will undergo the treatment prescribed by the study. During or after treatment, the patient may have more blood tests or imaging studies done. These help researchers monitor the patient’s progress and potential side effects. Patients should report all side effects to their physician or study coordinators. Researchers may be able to treat or minimize these side effects.
- Following patient progress after treatment: Researchers will continue monitoring patients for the duration of the study, even after treatment has stopped. This may involve office visits or telephone interviews.
Patients should remember that study participation is voluntary at all times. Even after signing the informed consent or receiving treatment, patients can drop out of the study for any reason.
03. Clinical Trials Questions
Patient Questions About Clinical Trials
Some patients may have questions and concerns about enrolling in a clinical trial. Answers to some of the most common patient questions are listed below. Patients can also discuss potential trials with their healthcare providers. The oncology team will be able to take into account the patient’s individual circumstances and make appropriate recommendations.
Are Clinical Trials Safe?
Because clinical trials involve medical procedures, they do come with risks. However, all medical procedures, even the most basic, have risks. In a clinical trial, patients are informed of known risks in advance. This allows them to decide for themselves if the potential benefit is worth the risk.
Researchers must also take steps to lower risks. Clinical trials are subject to numerous rules and regulations. The Federal Government and an Institutional Review Board (IRB) enforce the regulations. These stringent rules are intended to keep the risks of the study as low as possible.
How Do I Choose a Clinical Trial?
The best way to choose a clinical trial is with an experienced mesothelioma oncologist. A mesothelioma specialist can apply their experience to an individual’s situation. This will help determine which trial may offer the best balance of risk and benefit.
How Do I Enroll in a Clinical Trial?
Patients can view a list of actively enrolling mesothelioma trials on our Clinical Trials – Recruiting page. Each trial has its own eligibility criteria. If an individual believes they qualify for a trial, they should discuss it with their oncologist. Patients can also contact the study organizers directly. Contact information for the study organizers is included in the trial’s record on ClinicalTrials.gov.
How Do I Know if the Treatment Is Working?
Some patients may worry they could get an inactive treatment, or a placebo, as part of a clinical trial. They may also wonder how to know whether any form of treatment is working.
As part of any cancer clinical trial, doctors monitor patients at regular intervals. This monitoring generally includes tests designed to assess cancer status. Patients can discuss these test results with their physician to understand how they are responding to treatment.
How Are a Clinical Trial and a Clinical Study Different?
A clinical study is a medical study involving people. A clinical trial is a specific type of clinical study. There are two main types of clinical studies: clinical trials and observational studies.
In a clinical trial, participants are assigned to a specific treatment group. They receive that treatment, and researchers monitor the results.
In an observational study, researchers monitor the outcomes of groups of patients. These patients are not assigned to a specific treatment group. Instead, they receive routine medical care according to their doctor or oncologist’s recommendations. That routine medical care may or may not include new or emerging treatments.
Clinical trials and observational studies can be registered with ClinicalTrials.gov. However, many observational studies do not register. Instead, these studies are monitored entirely by an Institutional Review Board (IRB).
Both clinical trials and clinical studies may give mesothelioma patients access to new treatment options. Anyone interested in a clinical trial or study should discuss those options with their oncologist.
What Kinds of Treatments Do Clinical Trials Test?
Clinical trials test a variety of treatments for both malignant pleural mesothelioma (MPM) and peritoneal mesothelioma. Some trials focus on combining treatments such as surgery and radiation therapy. Other studies have investigated specific chemotherapy combinations for patients with inoperable (unresectable) mesothelioma.
One such trial tested the chemotherapy drugs pemetrexed and cisplatin for first-line treatment of pleural mesothelioma. The combination of drugs extended survival by about three months versus cisplatin alone.
04. Recent Successes
Successful Mesothelioma Clinical Trials
Researchers are continually working to improve mesothelioma treatment through clinical trials. Various studies have demonstrated the value of this mesothelioma cancer research. Some studies have found ways to improve overall survival in patients who do not qualify for standard treatment. Other studies have helped improve the quality of palliative care options.
KEYNOTE-158 | Immunotherapy Success
In this study, researchers evaluated a new immunotherapy drug in a difficult situation. They administered the drug, Keytruda® (pembrolizumab), to two classes of malignant pleural mesothelioma patients:
- Patients who could not tolerate standard therapy
- Patients for whom standard therapy failed
Researchers found the drug showed “durable antitumor activity” in the study.
STELLAR Trial | Electric Fields to Fight Mesothelioma
This study investigated a novel device in patients with inoperable pleural mesothelioma. The device, the Optune Lua™, creates Tumor Treating Fields (TTFields). TTFields are mild, wave-like electric fields capable of interfering with tumor cell growth. TTFields may even kill cancer cells.
In the STELLAR trial, pleural mesothelioma patients received chemotherapy and TTField treatment. Median survival in the trial was 18.2 months, which researchers described as “encouraging.”
MesoVATs | Improvements in Palliative Care
This study evaluated two treatment options for pleural effusion caused by pleural mesothelioma. Pleural effusion is a condition in which fluid collects in between the two layers of the pleura (lining around the lung).
Some patients received talc pleurodesis, a procedure that collapses the two layers of the pleura. Other patients underwent video-assisted thoracoscopic partial pleurectomy (VAT-PP). VAT-PP is a minimally invasive procedure that removes the pleura. The goal of both procedures is to prevent pleural effusion.
Researchers determined talc pleurodesis was superior to VAT-PP. Talc pleurodesis led to shorter hospital stays and fewer complications with similar survival.
05. Trial Phases and Funding
Additional Clinical Trials Information
New treatments must demonstrate safety and success in clinical trials before they can be offered to non-study patients. The U.S. Food and Drug Administration (FDA) typically requires three or four phases of trials before it grants approval.
Mesothelioma Clinical Trials Funding
Clinical trials are often funded by the government or drug companies. However, there may be additional patient costs that should be taken into consideration. Health insurance may offer some coverage, but it depends on the patient’s individual case. Coverage can vary between private insurance and government programs like Medicare and Medicaid.
Insurance often covers certain study-related patient care costs, including:
- Doctor visits
- Hospitalizations
- Imaging (X-rays or MRI scans)
- Laboratory tests
- Standard cancer treatments
- Treatments to improve side effects
Out-of-pocket costs can include copays or deductibles. Additional fees may also arise with out-of-network care.
In addition to some coverage limitations, patients should keep other potential fees in mind. Deciding to pursue a clinical trial could require travel and housing expenses. For some patients, travel may require paying for a caretaker to watch loved ones during treatment.
Some trials will provide travel and housing stipends for patients who need to travel significant distances to participate. Patients may also find grant programs or other options to help cover additional costs of participating in a clinical trial.
