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Mesothelioma clinical trials

A mesothelioma clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

The benefits of participating in a clinical trial include the following:

• Participants have access to promising new approaches that are often not available outside the clinical trial setting.
• The approach being studied may be more effective than the standard approach.
• Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.
• Participants may be the first to benefit from the new method under study.
• Results from the study may help others in the future.

The possible risks of participating in a clinical trial include the following:

• New drugs or procedures under study are not always better than the standard care to which they are being compared.
• New treatments may have side effects or risks that doctors do not expect or that are worse than standard care.
• Participants in randomized trials will not be able to choose the approach they receive.
• Health insurance and managed care providers may not cover all patient care costs in a study.
• Participants may be required to make more visits to the doctor than they would if they were not in the clinical trial.

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a mesothelioma clinical trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Mesothelioma clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

There are several types of clinical trials:

Prevention trials study ways to reduce the risk, or chance, of developing cancer. Most prevention trials are conducted with healthy people who have not had cancer. Some trials are conducted with people who have had cancer and want to prevent the return of cancer (recurrence), or reduce the chance of developing a new type of cancer.

Screening trials study ways to detect cancer. They are often conducted to determine whether finding cancer before it causes symptoms decreases the chance of dying from the disease. These trials involve people who do not have any symptoms of cancer.

Diagnostic trials study tests or procedures that could be used to identify cancer more accurately and at an earlier stage. Diagnostic trials usually include people who have signs or symptoms of cancer.

Treatment trials are conducted with people who have cancer. They are designed to answer specific questions about, and evaluate the effectiveness of, a new treatment or a new way of using a standard treatment. These trials test many types of treatments, such as new drugs, vaccines, new approaches to surgery or radiation therapy, or new combinations of treatments.

Supportive care (or quality of life) trials explore ways to improve the comfort and quality of life of cancer patients and cancer survivors. These trials may study ways to help people who are experiencing nausea, vomiting, sleep disorders, depression, or other effects from cancer or its treatment.

Genetics studies are sometimes part of another cancer clinical trial. The genetics component of the trial may focus on how genetic makeup can affect detection, diagnosis, or response to cancer treatment.

Population and family-based genetic research studies differ from traditional cancer clinical trials. In these studies, researchers look at tissue or blood samples, generally from families or large groups of people, to find genetic changes that are associated with cancer. People who participate in genetics studies may or may not have cancer, depending on the study. The goal of these studies is to help understand the role of genes in the development of cancer.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

There are some phases of clinical trials in which a treatment is studied before the treatment is eligible for approval by the FDA (Food and Drug Administration).

phase I trial
The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments. The purpose of a Phase I study is to find the best way to give a new treatment and how much of it can be given safely. Physicians watch patients carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies, but the side effects in patients are not completely predictable.

phase I/II trial
A trial to study the safety, dosage levels, and response to a new treatment.

phase II/III trial
A trial to study response to a new treatment and the effectiveness of the treatment compared with the standard treatment regimen.

phase III trial
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people. Phase III trials require entry of large numbers of patients; some trials enroll thousands of patients. One of the groups may receive standard (the most accepted) treatment, so the new treatments can be directly compared. The group that receives the standard treatment is called the "control group. " For example, one group of patients (the control group) may receive the standard chemotherapy for a certain type of cancer, while another patient group may receive another type of chemotherapy that may or may not contain an investigational drug to see if this improves survival. All patients in Phase III trials are monitored closely for side effects, and treatment is discontinued if the side effects are too severe.

phase IV trial
After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.

Non-Drug Related Clinical Trials

Non-drug related clinical trials are much the same as drug clinical trials with the exception that they do not always require FDA approval. Whereas drug clinical trials consist of four phases, non-drug related clinical trials typically consist of three.

Although the FDA does not regulate the development of new treatment modalities, it does regulate any newly developed medical devices used in the practice of such treatments. For example, the development of a new surgical procedure aimed at curing malignant mesothelioma is not regulated by the FDA; however, a newly developed surgical tool used to perform the surgery does require FDA approval. The FDA approves the safety and efficacy of the device as opposed to the safety and efficacy of the treatment.

The Mesothelioma Applied Research Foundation (MARF) lists mesothelioma clinical trials on their site. Once you find a trial on one of these web sites that seems like it might be beneficial, you should call the center where it's being conducted to find out as much as you can about the risks, potential benefits, eligibility requirements, and costs and then discuss the suitability of the trial with your medical team and your family or close friends. If they have other questions you didn't think of, call back and ask the center conducting the test.

The same clinical trial may be conducted at various locations so be sure to ask for all locations. You may find a location close to home, or close to the homes of relatives or friends with whom you can stay during treatment. It is certainly convenient to find clinical trials close to home, but remember there are organizations that can help you with travel expenses and a place to stay.

Costs

The cost of clinical trials can be tricky and it's important to determine who pays for what.

There are two types of costs in clinical studies:

• patient care costs
• research costs

Patient care costs are generally those which you would have even if you were receiving traditional treatment, such as doctor visits, hospital stays, lab tests, x-rays, and the like. The patient is usually responsible for these costs and you need to determine whether your insurer will pay for them.

Often, the cost of investigational drugs and research costs, such as tests performed solely for research purposes, are covered by the sponsor of a clinical trial but you should always check which costs are covered by the sponsor and which are not.

Medicare reimburses certain patient care costs in clinical trials. See their website or call 1-800-MEDICARE (1-800-633-4227). In NCI-sponsored trials, TRICARE, the Department of Defense's healthcare program covers certain patient care costs and the VA covers certain costs for eligible veterans. See the cancer.gov website for more information.

Some states now require coverage of patient care costs (not research costs) in certain clinical trials. Click here to see if your state has laws that may help.

The NCI sponsors clinical trials around the country. There is no charge for medical care at NCI-sponsored clinical trials at the NIH Clinical Center in Bethesda, Maryland but patients are responsible for travel costs for their initial screening visit. Usually, once a patient is enrolled in a trial there, the NCI covers transportation costs for all later visits for patients who do not live locally and these patients usually receive a small daily amount for food and lodging expenses if they are being treated as outpatients. You can search their site for more information.

Note: different websites have different information, so look everywhere and call to find out as much as you can about what's available.

Who Sponsors Clinical Trials? Who Conducts Them?

Of the thousands of cancer clinical trials going on at any one time, the US National Cancer Institute (NCI), a part of the National Institutes of Health (NIH), sponsors (pays for the costs of) a good portion of them. These studies are often run by NCI-sponsored cancer cooperative groups, which are networks of doctors and institutions across the country who specialize in a particular aspect of cancer.

There are currently 10 major cooperative groups conducting studies:

• American College of Radiology Imaging Network (ACRIN)
• American College of Surgeons Oncology Group (ACOSOG)
• Cancer and Leukemia Group B (CALGB)
• Children's Oncology Group (COG)
• Eastern Cooperative Oncology Group (ECOG)
• Gynecologic Oncology Group (GOG)
• National Surgical Adjuvant Breast and Bowel Project (NSABP)
• North Central Cancer Treatment Group (NCCTG)
• Radiation Therapy Oncology Group (RTOG)
• Southwest Oncology Group (SWOG)

Researchers conduct clinical trials in many different settings. Major cancer centers are the most common; because they usually have the most advanced facilities and highly trained staffs, they can conduct all phases of clinical trials. But they are not the only places where these studies take place.

Community hospitals across the country also participate in clinical trials, although these are usually phase II or III studies. Many of these hospitals are part of the NCI’s Community Clinical Oncology Program (CCOP). CCOP members conduct the same clinical trials across the country. Community hospitals may conduct other, privately sponsored, studies as well.

Doctors in private practice can also be involved in clinical trials, either as members of cooperative groups or by being actively involved in private research. But many doctors decide not to conduct clinical research, for a variety of reasons.

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