Mesothelioma Clinical Trials

Clinical trials underway at cancer centers around the country may provide the best hope for beating mesothelioma. These trials provide patients with access to cutting-edge treatments that can make a difference in their life expectancy, and they also play an essential role in future advancements in the fight against asbestos cancer.

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What Is a Clinical Trial?

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What exactly is a clinical trial? In simple terms, they're research studies that involve people. Each trial has a focused, unique purpose. They can be sponsored by Specialized Programs of Research Excellence, which brings researchers and scientists together with patients, governmental agencies like the National Cancer Institute (NCI) or by Community Clinical Oncology Programs.

Clinical trials strive for new research that involves new drugs, new therapies and different combinations. Even though a clinical trial might not provide an “Ah, ha!” moment – the treatment breakthrough every mesothelioma specialist wants – simply pushing treatment to a new place helps. Trials let doctors measure the effectiveness, and get a clearer picture, of the newest drugs and most up-to-date treatment procedures.

Immunotherapy and gene therapy, for example, are not yet FDA approved for mesothelioma, but they are available in clinical trials -- and considered the future of treatment with many cancers.

A trial can last for weeks, months or years, depending on the goal and whether the drug or treatment needs additional testing to reach the market. Many drugs require more than one trial to determine their efficacy.

Each trial requires extensive planning, funding and stringent execution. Because of strict federal and industry guidelines, they must be conducted in safe, regulated facilities.

Why Should I Participate?

Patient Advocate Karen Selby explains how clinical trials benefit mesothelioma patients.

Because there is no cure for mesothelioma, scientists and clinicians are continually researching new therapies to provide patients with life-extending treatments and ways to improve their quality of life.

Patients who have not responded to conventional therapies and may have no other treatment options available are usually the optimal candidates for clinical trials.

Clinical trials are what makes progress possible. It fuels the engine of hope. By participating in a mesothelioma clinical trial, not only are you giving yourself a better chance at beating the cancer, but you are also helping future patients by providing doctors and researchers with valuable information and feedback.

"When we talk about being in a clinical trial, the first reaction sometimes from a patient is, 'You want me to be a guinea pig?' And I say no, I want you to be a hero. A hero is someone who puts his life out there to help others, someone who really gives of himself. If we keep using the same treatments, we'll never find a better one."
Director of Hematology/Oncology, University of Vermont Medical Center

Dr. Fontaine talks about clinical trials for patients whose traditional treatments were unsuccessful.

The National Cancer Institute (NCI) estimates that less than 5 percent of all cancer patients in the United States are part of a clinical trial, which makes it difficult to uncover new treatments for rare cancers with such a small pool of patients.

"Participating of patients with mesothelioma in clinical trials is essential if we are going to make progress and develop novel therapies," said Raffit Hassan, M.D., a senior investigator at the NCI.

The best news is, patients don't have to wait to get into these trials. Dozens of trials about mesothelioma and asbestos lung cancer are recruiting for patients at all times. And while governmental regulations require a lengthy testing period — often more than a decade – before treatments can gain FDA approval, individuals can walk right into treatment without a time barrier.

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What Concerns Should I Have?

When a patient participates in a clinical trial, there are always certain risks because these are experimental drugs and treatments.

  • Potential Health Risks: The trial may result in ineffective treatment that doesn't achieve the desired conclusions or causes further harm to your health. Furthermore, you could end up experiencing side effects.

  • Costs: Research and patient care expenses are the most common costs. Patient costs may include two subsets of expenses, which are routine care costs and extra care costs. Routine care involves doctor and hospital visits or stays. This portion is often paid by a health insurance company. Extra costs include additional tests required for the trial.

Some states require health insurance companies to pay for routine medical care given in a clinical trial. This partial coverage may provide a little relief for mesothelioma patients. However, this only applies for routine medical care, and not all trials fall under this umbrella.

Factors that determine if insurance companies will pay for clinical trial costs include:

  • If the study is classified as experimental or more of a treatment
  • Duration of the study
  • Risks involved with the specific trial

Who Pays for Clinical Trials?

While patients cover some of the expenses, government agencies or pharmaceutical companies typically absorb the majority of the costs.

Government Funding

The 2007 budget for the NCI was about $4.9 billion. Overall funding for clinical trials for cancer research that year was $843.7 million. In 2010, the total funding for clinical trials was slightly larger: $852.2 billion.

In 2011, there were 188 clinical trials actively looking for participants or recently completed in the area of mesothelioma research. Sixty-five of those trials were funded by the NIH, two by the U.S. Department of Defense, 53 by pharmaceutical and biomedical companies and 70 by universities, cancer centers, hospitals and research organizations in the U.S. and abroad.

In addition, private donations may also help cover the costs of a mesothelioma clinical trial. For example, the University of Hawaii Cancer Center received a $3.58 million gift from an anonymous donor for mesothelioma research in 2011.

Patient Costs

These patient costs may include transportation, doctor visits, hospital stays, laboratory tests, X-rays and scans.

Although some of these costs are often covered by health insurance, depending on the patient's policy. Some states have laws or special agreements that require health insurance companies to pay for routine care received in a clinical trial.

Additional costs related to clinical trials that may not be covered by health insurance policies can include extra tests, doctor and nurse expenses, and research and analysis fees, which must be paid for by the organization sponsoring the trial.

For patients over the age of 65, Medicare covers routine costs related to all government-sponsored phase II and III clinical trials.

Remember to speak with the sponsor of the clinical trial to understand what costs they cover. Also, consult with your health insurance company to determine what they will cover.

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Phases of Clinical Trials

Clinical trials fall into one of three categories — prevention, screening or treatment – based on what the focus is. Each trial is divided into three phases. If a drug or treatment passes effectively through all three phases, then it can wind its way through the FDA approval process.

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Phase I

A Phase I trial involves a small group of people (20 or more) to analyze the safety of a drug or therapy. The goal is to analyze side effects and examine how the drug is processed by the body. It also looks at safe dosage levels.

Phase II

A Phase II trial, which includes up to 300 patients, includes a closer look at safety levels and just how effective the drug or the treatment is. It may be compared with other treatment options, or even a placebo.

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Phase III

A Phase III trial involves the largest group (up to several thousand people) and measures the effectiveness of the new treatment vs. standard treatment approaches. It also is used to finalize dosage amounts and document side effects.

Phase IV

Phase IV involves long-term testing of effectiveness and safety in a diverse patient population, usually after the FDA has approved treatment for standard use.

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Trials Now Looking for Patients

Dr. Tirrell Johnson explains what he tells newly diagnosed mesothelioma patients about clinical trials.

Because mesothelioma is such a rare disease — up to an estimated 3,000 patients in the United States are diagnosed annually with it — the actual number of patients in mesothelioma trials is small. The National Institutes of Health reports more than 100 mesothelioma clinical trials set for 2014. They are in various phases and for different disease types and for varying purposes. You should talk to your doctor about whether a mesothelioma clinical trial is right for you, and to see if you qualify to participate. Of the trials that are recruiting for participants, here are a few of the most notable ones:

  • Stem Cell Inhibitor Defactinib

    This Phase II, multi-center, multinational clinical trial involves the study of defactinib (VS-6063), a stem cell inhibitor that has shown considerable promise with other cancers. Stem cells are only a small percentage of cells in a tumor, but they are a major reason for cancer recurrence and disease progression. In this study, defactinib is used as maintenance following the standard chemotherapy regimen of pemetrexed. This is the first time a drug was designed to inhibit a particular protein (FAK) within the mesothelioma stem cell. Cancer centers in Chicago, Baltimore, New York, Cleveland, Philadelphia and Dallas are conducting this trial.

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  • Measles Virus

    This Phase I trial involves a genetically altered measles virus that triggers the body's immune system to recognize and attack mesothelioma tumor cells without harming the healthy ones. Scientists long ago recognized that the measles virus offered a delivery platform for an effective anti-cancer drug , and it already has shown promise with both prostate and ovarian cancers. The trial involves direct injection into the pleural cavity. This study is a collaborative effect between the Mayo Clinic in Rochester, Minn., and the National Cancer Institute in Bethesda, Md.

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  • Anti-Cancer Listeria Vaccine

    This multi-center, Phase I study focuses on the safety and immune response of CRS-207, a weakened form of Listeria. Scientists believe that this genetically altered virus can stimulate a natural immune response against the antigen mesothelin, which is more prevalent in tumors like mesothelioma. The trial will evaluate its effectiveness when given along with a standard chemotherapy regimen of pemetrexed and cisplatin. Locations for the trial include Tampa, Chicago, San Francisco, Philadelphia and Bethesda, Md.

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  • Tremelimumab for Unresectable Mesothelioma

    This Phase II trial, being done in numerous locations in several countries, may provide hope for those with unresectable pleural or peritoneal mesothelioma. Tremelimumab is an immunotherapy drug designed to unmask mesothelioma cells and allow the body's own immune system to destroy them. Tremelimumab has proven its value with other cancers, but has never been tried with mesothelioma. The study is part of a second-line treatment that also includes chemotherapy.

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Qualifying for a Clinical Trial

Your mesothelioma specialist can help you look over the clinical trials that are available. You may need to travel if you wish to participate. Each trial has specific guidelines that will determine your eligibility. Some of the guidelines may include:

Factors Considered for Clinical Trial Eligibility

  • Age and gender of patient
  • Overall health of the patient
  • Type and stage of mesothelioma
  • Patient's past treatment history
  • Underlying medical conditions

What Questions Should I Ask My Doctor?

Prior to enrolling, it is important for a mesothelioma patient to fully understand the details and purpose of the trial.

For example, patients should ask the trial sponsors about the specific goal of the clinical trial, other treatment options available, costs and possible side effects, among other concerns.

View and Print Some Questions to Ask About Clinical Trials

We've created a handy list of questions you can print and take with you. These cover some aspects of clinical trials you can ask the trial sponsors. Finding answers to your concerns will help you decide if you should participate in the clinical trial.

Take our handout home with you.

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Additional Resources


Karen Selby is a registered nurse and a Patient Advocate at The Mesothelioma Center. She worked in several subspecialties within nursing before joining Asbestos.com in 2009.

  1. Hassan, Raffit, M.D., Senior Investigator, National Cancer Institute, interview with Asbestos.com (2013, Oct. 16).
  2. Verschraegen, Claire, M.D., director, Hematology/Oncology Division, University of Vermont Medical Center, interview with Asbestos.com (2012, Sept. 12).
  3. http://clinicaltrials.gov/ct2/info/understand#Q19

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