4 Major Factors to Consider When You Want to Participate in a Mesothelioma Clinical Trial

Clinical trials for new mesothelioma treatments give hope for the discovery of a possible cure for the deadly cancer. Mesothelioma is an aggressive form of asbestos related cancer with a very high mortality rate, most victims die within 1-2 years after the diagnosis. The patients currently involved in mesothelioma clinical trials will hopefully lead to the discovery of better and more efficient ways of treating the disease. Consulting with a physician about various available clinical trials should be considered at the initial diagnosis.

A clinical trial is a process that new treatment options and medications pass through before they are approved for use by the general population. Many patients with terminal diseases are advised to participate in clinical trials as a last hope for a cure. Many drugs and therapies that become the standard therapy of care for many diseases have gone through an extensive period of testing with clinical trials before they were approved for general use.

Factors to Consider Before Taking Part in a Clinical Trial There are a variety of factors to take into consideration when considering participation in a clinical trial.

1- The distance to the trial center and the financial implications of taking part in the clinical trial

Clinical trials most times take place in large metropolitan hospitals located in the major cities, some of the patients however live in smaller towns far from these major cities. It is important to know how often participants will need to see the physicians coordinating the trials and how long each visit will take, and how much the hotel and travel expenses will likely cost.

2- Selection criteria for the trial

Not everyone qualifies for a clinical trial ,the criteria for selection for a particular drug trial varies. Some clinical trials will want patients that have tried using some other medication which did not work, while other clinical trials require that the participating patients have not started any treatment for their disease.

3- The risk factor

Another factor when considering a clinical trial is the loss of control over medical treatment. In some clinical trials, referred to as randomized studies, patients receive the traditional treatment while others receive the experimental treatment. The patient does not choose which treatment they receive, nor do they likely know what treatment is being administered. There is no guarantee that a participant will receive the experimental treatment. There is always a risk involved in using experimental drugs and treatments, they might have unknown side effects that will only show up when they are used by human beings.

4- General state of health of the patient

A patient’s general health is also a major consideration when preparing to participate in a clinical trial. Patients with other pre-existing medical disease will not be allowed to participate in most clinical trials as well as patients on other major medications. The presence of other medical diseases might affect the accuracy and reliability of the results of the clinical trials. Some of those other major medications might also interact negatively with the actions of the drugs that are on trial.

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Asbestosis and Mesothelioma Clinical Trial Basics

Mesothelioma and asbestosis patients may have heard about clinical trials, but don’t know where to start or what to expect. Clinical trials for asbestos related cancer and diseases have saved lives and defied statistics. A clinical trial might be the answer to improve the quality of life and prognosis for you or your loved one.

Asbestosis from asbestos exposure and the threat or diagnosis of mesothelioma are not only difficult to diagnose, they are difficult to treat. A general physician typically has little experience treating asbestosis or mesothelioma, and since the diseases are rare, tests for these diseases will typically be down the ladder in a long line of tests until the physician is aware of asbestos exposure.

The treatment options suggested typically start with chemotherapy, radiation and lung removal. But chemotherapy and radiation have had little success and can produce significant pain. Lung removal is dangerous, but often necessary. It is frequently met with short success until the cancer cells grow and spread. Participating in a clinical trial could be the answer to a longer life, or at least a better life. If the asbestosis or mesothelioma are in the later stages and standard treatment hasn’t worked, there isn’t much to lose and your participation will help future patients battle the odds for survival. In fact, clinical trial surveys show that most participants participate to help themselves and to help others.

Doctors often have enough medical news to deal with, and may only be aware of a few clinical trials available for treating asbestosis or mesothelioma. Asking your doctor and many other doctors in related fields what clinical trials are available is often the first step to finding a clinical trial to join. The next biggest and most time-consuming step is to use the Internet. Those who have been resisting the computer must learn that research on the Internet has the potential to lead the cancer patient to a better, longer and healthier life. Family, friends and volunteers can help research clinical trial options for asbestos-related diseases. These clinical trials can be sponsored by hospitals, pharmaceutical companies and other research organizations, universities, and are held all over the world. Keep in mind that transportation to these trials may be a burden, however there are organizations for support, and many people have been successful with fundraisers.

The first factor to evaluate is what qualifications are needed to participate. Once you find a list of clinical trials, you will have to examine what ages they are accepting, what stages of the disease they are accepting, and what prior treatment or non-treatment may be accepted. There are often many tests that need to be performed before the trial; however, it is also likely many of these tests have already been performed. Clinical trials do not arise quickly, and often there are months to wait – which is frightening for someone who has months to live. Persistent research and persistent phone inquiries on cancellations or alternatives can speed up the treatment.

Asbestosis and mesothelioma clinical trials have been promising. The trials may include a mix of drugs, a new kind of therapy based on injections, laser surgery, or even gene therapy. There are hundreds of clinical trials available but they do take a great deal of research to find. Getting the assistance from a volunteer will make shuffling through the tests and medical terminology easier. Clinical trials might be the answer to overcoming your asbestosis or mesothelioma. Start researching, ask for help, and be persistent. Your life isn’t ready to wait, and it’s best to start now.

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Are Mesothelioma Clinical Trials Safe?

If you are a cancer sufferer and you are not sure whether to take part in a clinical trial or not; it can be a very difficult and frustrating decision.

Basically clinical trials are studies based around people and how they react to certain medical treatments. The doctors will be making sure that any new mesothelioma treatment is totally safe for human use and is actually effective. These mesothelioma trials are vitally important to determining whether or not a treatment or a procedure can actually help sufferers or maybe even cure.

It can be difficult to determine whether or not to actually take part in any clinical trial as you nor the doctors know what is going to happen and how it’s going to turn out; this is the whole point to the trials. If you already knew what was going to happen there would be no need for trials and the treatment would just be administered.

Many people do not bother paying any attention to clinical trials until the day they are diagnosed with something that is included in trials. There are instances where trials do go wrong and people suffer more; this is rare; the media do not report on good clinical trials only the negative ones. Of course this is par for course in certain clinical trials as that is what they are designed for; no one knows the outcome of the trials.

Thousands upon thousands of people are helped every year through mesothelioma clinical trials however, and millions more benefit from the successful outcomes to any clinical trial not just the mesothelioma clinical trials. That is why it is important that people do get involved in the medical trials, as without them there would not be any advances in science and in treatment. However, it is an extremely personal choice to make, and you should never feel pressured at any time to undertake a trial.

The decision is an extremely personal decision when it comes to clinical trials; talk it over with your friends and families and see if you can gain any support and help from them as well. You will need to think about your choices and always make sure you are 100% in whatever your decision may be! Your family and your friends will be a good point of comfort and care when you undertake the mesothelioma cancer treatment trials, so always keep them close and fully informed.

If you are considering taking part in a mesothelioma clinical trial then get as much information as you can about what it will entail, what may happen, any known dangers or side effects and the such like.

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Important Tips on How You Can Participate in a Mesothelioma Clinical Trial

A clinical trial is a process that all new treatment options and medications go through before they are accepted and registered for general usage. These trials often offer a last hope for cure for many terminal and difficult diseases. Most drugs that have become standard therapies for many illnesses today have all undergone an extensive period of testing with clinical trials.

There are three stages of clinical trials. Phase I trials enroll a limited number of people. They normally center on the correct dosage and relative safety of a particular drug. Phase II trials enroll more people and are used to determine if the new drug actually works against a particular illness. Phase III trials are the final phase before a drug is approved for treating a disease. During Phase III, the new drug is compared against the existing treatment. The goal during Phase III is to prove the new drug is a more effective treatment.

To find about clinical trials you can participate in you can check on the internet for resources that list ongoing clinical trials for mesothelioma, which include the qualifications for each.

You can also consult your mesothelioma doctor for information on available clinical trials. Doctors have access to all upcoming and current clinical trials, and can also help determine if a patient qualifies for a particular trial.

You can also contact the large regional cancer centers in their area, which will have access to information on clinical trials being coordinated from their hospitals

You have to consider a lot of factors if you want to take part in a clinical trial. Clinical trials typically occur in large metropolitan hospitals and it is important to know how often participants will need to see the physicians coordinating the trials and how long each visit will take, these visits will translate into a lot of hotel and travel expenses.

Not everyone qualifies for a clinical trial, different trials use different criteria for selecting eligible participants. Some clinical trials want participants that that have undergone an unsuccessful traditional treatment, while other clinical trials want patients who have not been treated at all.

Another factor that you have to consider about clinical trial is that you will have no control over the kind of treatment you will receive. In randomized clinical trials, patients receive the traditional treatment while others receive the experimental treatment. You do not get to choose which treatment you receive, nor will you know what treatment is being administered. There is no guarantee that a participant will receive the experimental treatment.

Despite apparent risks, the benefits of clinical trials are numerous. Without clinical trials it would be nearly impossible to judge the effectiveness of new drugs. The health care that participants receive during a clinical trial is fantastic. Careful records must be kept and extensive testing must be done to gauge the effectiveness and safety of a new therapy.

Mesothelioma is an aggressive form of asbestos cancer with an extremely low survival rate and clinical trials are one of the best ways to find a cure. The patients currently involved in mesothelioma clinical trials will hopefully pave the way for a more effective treatment. You must consult with your doctor about the various available clinical trials once you are diagnosed with mesothelioma.

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Commonly Asked Questions About Mesothelioma Clinical Trial

Most people have some concerns about taking part in a clinical trial, often because they’re not really sure what it will mean for them. Taking time to get as much information as you need before you decide is the best way to be sure that you will make the choice that is right for you. These are the commonly asked questions about mesothelioma clinical trials:

1- Is the clinical trial risky?

Yes, all clinical trials have risks. Every medical test, drug, or procedure has risks. The risk may be greater in a clinical trial because some aspects of any new treatment are unknown. This is especially true of phase I and II clinical trials, where the treatment has been studied in fewer people.

Perhaps a more important question is whether the risks are outweighed by the possible benefits. Since mesothelioma cancer is often a terminal disease with the current treatment modalities offering little hope in terms of cure, most victims are often willing to accept a certain amount of risk for a chance to be helped, but it is always important to be realistic about what this chance is. Ask your doctor to give you an idea of what the possible benefits are, and exactly what benefit is likely for you.

With this in mind, you can make a more informed decision. Some people may decide that any chance of being helped is worth the risk, while others may not. Others may be willing to take certain risks to help others.

2- Will I just be used as an experimental “guinea pig?”

There’s no denying that the ultimate purpose of a clinical trial is to answer a medical question. People who take part in clinical trials may need to do certain things or have certain tests done to stay in the study.
But this does not mean that you will not get excellent, compassionate care while in the study. In fact, most people enrolled in clinical trials appreciate the extra attention they get from their health care team. In 2005, the Coalition of Cancer Cooperative Groups surveyed over 1,700 people with cancer on their awareness and attitudes about clinical trials. Only a few had taken part in clinical trials. But most of those who did were very satisfied: 96% said they were treated with dignity and respect, 92% said they had a positive experience, and 91% would recommend that family or friends take part in a clinical trial if faced with cancer.

3- Will I get a placebo?

Most mesothelioma cancer clinical trials do not use placebos unless they are given along with an active drug. It would be unethical to give someone an inactive medicine as it would deny the mesothelioma victim of availing themselves of the available treatment for the cancer.

The very least you should expect from any clinical trial is to be offered the standard of care already being used.

4- Will my information be kept confidential?

As much as possible, all of your personal and medical information will be kept confidential. Of course, your health care team needs this information to give you with the best possible care, just as they would if you were not in a clinical trial.

Medical information that is important for the study, such as test results, is usually put on special forms and into computer databases. This is then given to the people who will analyze the study results. Your information is assigned a number or code ,your name is not on the forms or in the study database. Sometimes, members from the research team or from the Food and Drug Administration may need to look at your medical records to be sure the information they were given is correct. But your personal information is not given to them and is never used in any published study results.

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How to Choose the Best Mesothelioma Clinical Trial

You can find out about good mesothelioma clinical trials in different ways. You can enter for clinical trials do so after hearing about them from your doctor. You can also actively look for clinical trials on the Internet or in other places, hoping to find more options for treatment. Some clinical trials are advertised directly to patients.

Information about mesothelioma cancer resources can be obtained from several resources. These resources can be divided into 2 main types: clinical trials lists and clinical trials matching services.

1- Clinical trial lists

These sources give you the names and descriptions of clinical trials of new treatments. If there is a study you are interested in, you will probably be able to find it in a list. The list will often include a description of the study, the criteria for patient eligibility, and a contact person. If you (or your health care providers) are willing and able to read through descriptions of all the studies listed for your cancer type, then a list may be all you need. Some organizations that provide lists can help you narrow the list a little, according to the kind of treatment you are looking for (chemotherapy, immunotherapy, radiation therapy, etc.) and the stage of your cancer.

2- Clinical trials matching services

Over the past few years, several organizations have developed computer-based systems to match patients with studies they may be eligible for. This service is often offered online.

Each may differ somewhat in how it works. Some of the services allow you to search for clinical trials without registering at the site. If you have to register, they usually assure you that your information will be kept confidential. Either way, you will probably have to enter certain details, such as the type of cancer, the stage of the disease, and any previous treatments you may have had. When given this information, these systems can find clinical trials for which you may be eligible, and save you the time and effort of reading descriptions of studies that are not relevant to you. Some groups also allow you to subscribe to mailing lists so that you are informed as new studies open up.

Although they are usually free to users, most clinical trial matching services get paid for listing studies or get a finder’s fee from those running the studies when someone enrolls. Because of this, there may be some differences in the way they rank the studies, or the order in which they present the studies to you.

Because different services work differently, be sure you understand how the service you are looking at operates. Ask the following questions. (Note that the answers do not necessarily mean that the service is not worth using.)
•Is there a fee for using the service?
•Do I have to register to use the service?
•Does the service keep my information confidential?
•Where does the service get its list of clinical trials?
•Does the service rank the studies in any particular order? Is this based on fees they get?
•Can I contact the service through the Internet or by telephone?

Examples of clinical trials matching services are:

1- The American Cancer Society Clinical Trials Matching Service:
The American Cancer Society helps patients find high quality care in clinical trials that best match their medical needs and personal preferences, while helping researchers study more effective treatments for future patients

The TrialCheck® database, developed and maintained by the Coalition of Cancer Cooperative Groups, is a comprehensive database that includes the Coalition, National Cancer Institute, and industry trials. To our knowledge, this is the most complete matching database of cancer clinical trials available.

The clinical trials information provided by the American Cancer Society is not biased in any way. It is updated every day, as is the contact information that allows patients to get in touch with the doctors and nurses at cancer centers running each of the studies.
You can access the TrialCheck at www.cancer.org (click on “Find a Clinical Trial”) or through a toll-free number, 1-800-303-5691.

2- The National Cancer Institute (NCI) sponsors most government-funded cancer clinical trials. The NCI has a list of active studies (those currently enrolling patients), as well as some privately funded studies. You can find the list on their Web site at www.cancer.gov/clinicaltrials or by calling 1-800-4-CANCER (1-800-422-6237). You can search the list by the type and stage of cancer, by the type of study (for example, treatment or prevention), or by zip code.

3- The National Institutes of Health (NIH) has an even larger database of clinical trials at www.clinicaltrials.gov, but not all of these are cancer studies.

4- EmergingMed provides a free and confidential matching and referral service for cancer patients looking for clinical trials at www.emergingmed.com, or you can call 1-877-601-8601.

5- CenterWatch (www.centerwatch.com) is a publishing and information services company that keeps a list of both industry-sponsored and government-funded clinical trials for cancer and other diseases.

6- Private companies, such as pharmaceutical or biotechnology firms, may list the studies they are sponsoring on their Web sites or offer toll-free numbers so you can call and ask about them. Some of these firms also offer matching systems for the studies they sponsor. This can be helpful if you are interested in research on a particular experimental treatment and know which company is developing it.

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Mesothelioma Clinical Trial-An overview of three important clinical trials

Clinical trials are used to find out whether the treatment is safe for general use and whether it is actually effective against diseases. Participation in clinical trials is an important treatment option for many patients with mesothelioma as much of the currently used treatments offer little hope for a cure.

Mesothelioma is very resistant to treatment  and medical experts believe that there could be an epidemic of mesothelioma cases in years to come. Clinical trials (research studies with people) are designed to find new treatments and better ways to use current treatments, raising hope for victims of this devastating disease. These are three important ongoing clinical trials for mesothelioma treatment.

1-Phase III Vorinostat (SAHA) clinical trial for progressive or relapsed malignant pleural mesothelioma patients. This trial is studying the use of chemotherapy drug vorinostat to kill cancerous cells and stop their division, it is also believed that the drug can inhibit enzymes that are needed by the cancerous cells for growth and multiplication. These studies are currently in the third phase to understand its effects on epithelial, sarcomatous, and recurrent mesothelioma. Phase III Vorinostat (SAHA) trials for progressive or relapsed malignant pleural mesothelioma patients are currently underway at the Jonsson Comprehensive Cancer Center at UCLA and Warren Grant Magnuson Clinical Center – NCI Clinical Studies Support, Bethesda, Maryland.

2-Phase II AZD2171 clinical trial for patients with unresectable malignant mesothelioma Phase II AZD2171 for patients with unresectable malignant mesothelioma is investigating the use of chemotherapy drugs to inhibit enzymes that slow the growth and block the supply of blood into the cancerous cells. Cancer cells depend on the formation of new blood vessels to bring blood that will supply the nutrients that they need for growth, new drugs are being studied that will inhibit the development of these new blood vessels. This study hopes to result in the development of drugs that will be used to treat epithelial, sarcomatous, advanced, and recurrent malignant mesothelioma. These clinical trials are underway in Arizona, Georgia, Illinois, Indiana, Iowa, Kansas, Massachusetts, Michigan, Missouri, Montana, North Carolina, Ohio, South Carolina, Tennessee, Virginia, Washington, and Wyoming.

3-Phase II clinical trial on the use of Pemetrexed Disodium with Gemcitabine or Carboplatin in advanced malignant mesothelioma patients. The Phase II clinical trial on the use of Pemetrexed Disodium with Gemcitabine or Carboplatin in advanced malignant mesothelioma patients clinical is a study to study the effects of chemotherapy drugs pemetrexed disodium, gemcitabine, and carboplatin on advanced and recurrent malignant mesothelioma. This study is in phase II and is being conducted in several locations across the country including Delaware, Florida Illinois, Indiana, Iowa, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, South Dakota, and Wisconsin.

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Best To Know These Things

Clinical trials are generally bio-medic research studies in humans that strictly follow a pre-defined protocol. It is a process that all potential treatment alternatives and medicines go through before they are considered safe or effective for the general population.

People who participate in these trials are most often than not patients who have invasive and treatment-resistant diseases. Most of these patients see it as their last hope for a cure.

There are three stages.

Phase I
is for determining the correct dosage and safety of a particular drug. This phase is not to test the efficacy of the drug, but more the safety. This phase is normally tested in a small group of people; usually 20-80 persons for the first time.

Phase II
is for determining if the new drug actually works against a particular health problem. This stage further evaluates the optimum dosage and confirms the results of Phase I trials. Phase II gives tests to a larger group of people; around 100-300 persons.

Phase III
is the final phase of a clinical trial before the new drug is approved for treating a disease. In this stage, the new drug is compared against the current standard treatment for a particular illness. Different doses and drug combinations are also tested in this stage. Up to 3,000 people are participative in the last phase.
A fourth stage is used nowadays for post-marketing studies. This phase determines if a drug or treatment is safe over time, and is done only after all three previous phases were approved by the FDA.

Doctors conduct clinical trials before any new treatment is recommended to patients. Since mesothelioma is one of the most devastating diseases, participation in such trials has become an important option for many malignant mesothelioma patients.

There are clinical trial reports on mesothelioma and all were aimed to raise hope for patients suffering from this disease.

Phase III Vorinostat (SAHA) trial is conducted for progressive malignant pleural mesothelioma patients. In this trial, doctors use Vorinostat, a chemotherapy drug, to kill cancerous cells, stop their division, and block enzymes that cells need in order to grow and multiply.
Phase II Pemetrexed Disodium with Gemcitabine or Carboplatin advanced malignant mesothelioma patients is a study conducted to examine the effects of chemotherapy drugs such as Gemcitabine, Pemetrexed Disodium, and Carboplatin on advanced and recurrent malignant mesothelioma.
Phase II AZD2171 is a study for patients with unresectable malignant mesothelioma. Here, doctors investigate the use of chemotherapy drugs to inhibit enzymes which slow the growth and block blood flow into the tumor. This study aims to help victims suffering from sarcotamous, advanced, epithelial, and recurrent malignant mesothelioma.

The individuals who participate in extensive clinical trials are brave individuals who wish to take a more active role in helping mesothelioma patients. These individuals greatly contribute to a more thorough understanding of this disease and help further medical science’s options in treating mesothelioma.

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Mesothelioma Clinical Trials

Clinical trials, phases I through III, are experimental treatments that have not yet been proven to be effective enough to be accepted as standard treatment. In fact, they are done for the purpose of determining whether they are or are not effective, and of determining to what degree they are effective. Results from clinical trials are compared with other forms of treatment to determine the most effective treatments under varying conditions. Clinical trials types include:

• Prevention trials

• Screening trials

• Diagnostic trials

• Treatment trials

• Quality-of-life, or Supportive care trials

• Genetics studies

What Kinds of Clinical Trials are Available for Mesothelioma Patients?

Clinical trials for treatment of mesothelioma might be designed to find a new treatment, or to improve a standard one. They test new drugs, radiation therapy, vaccines, new methods of surgery, or new treatment combinations.

Quality-of-life, also called supportive care trials work to improve cancer patients’ and survivors’ quality of life, comfort, or reduce the side effects of treatment or the cancer, itself.

How to Enroll in a Clinical Trial.

If your physician is unable to offer you a treatment or surgical option that he believes will cure, or improve, your condition, you may be eligible to enroll in a clinical trial. Your physician will be able to tell you which clinical trials are appropriate for you, and how to enroll.

Who Pays for Clinical Trials?

Clinical trials are not free. As with any medical treatment, you are responsible to pay for payment. If you have health insurance, you will need to find out whether or not they cover the particular clinical trial you intend to undergo. If your policy states that it considers clinical trials to be experimental or investigative, it may not cover any or your expenses for this treatment.

Increasingly, states are passing laws that require coverage for at least the routine care you would get during a clinical trial. These include doctor visits, hospital stays, lab work and x-rays and other costs common to any covered treatment that you might receive. In most cases the group sponsoring the trial will cover some of the costs of the clinical trials. These would include the costs that are related to tests that are done solely for research purposes.

The National Cancer Institute (NCI) is one of those research groups. NCI is working with major health insurance companies and managed care groups, and Medicare covers patient care clinical trial costs. NCI offers links to articles about clinical trials that may answer many of your questions. Other links to valuable information are at NCI Publications.

What Happens During a Clinical Trial?

There are four phases of treatment clinical trials:

Phase I: First step in testing a new treatment in humans

• Evaluates effective dose, route of delivery, and frequency of treatment

• Evaluates harmful side effects

• Involves only a small number of human subjects

Phase II:

• Studies safety and effectiveness of this treatment

• Evaluates effect on human body

• Limits to a specific type of cancer

• Involves fewer than 100 patients

Phase III: Compares this treatment to the current standard treatment

• Patients are randomly assigned to either the standard treatment or the one under study

• Treatments at phase III have shown promise based upon results from phases I and II

• Involves large numbers of people from many different places in the country

Phase IV:

• Evaluate the long-term safety and outcomes of this treatment

• Usually done after treatment is approved as a standard treatment

• Involves hundreds to thousands of people to ensure consistency in results

A 2002 study at phase III showed that a new chemotherapy drug regimen was effective in extending the lives of mesothelioma patients while reducing pain and discomfort.

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