Mesothelioma Clinical Trials

Clinical trials underway at cancer centers around the country may provide the best hope for beating mesothelioma or at least living with it for as long and as well as possible. These trials can give patients access to cutting-edge treatments, and they play an essential role in advancing the science of cancer treatment.

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Clinical trials are what make progress possible. They fuel the engine of hope. By participating in a mesothelioma clinical trial, not only are you giving yourself a chance to receive the best treatment available — you are also helping future patients by providing doctors and researchers with valuable information and feedback.

Mesothelioma Clinical Trial Facts:

  • Clinical trials are a safe, structured way to test experimental treatments.

  • Many mesothelioma trials are of drugs already approved for other cancers.

  • Dozens of clinical trials are actively recruiting mesothelioma patients.

  • Each clinical trial has different criteria for who is eligible to enroll.

What Is a Clinical Trial?

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

Clinical trials are research studies that involve people. In terms of mesothelioma treatment, a clinical trial is a carefully controlled way to test whether a new therapy approach is safe, effective and better than existing therapies. When scientists suspect a new drug, technology or combination of therapies will help patients live longer and better lives, clinical trials give the scientists a way to prove it.

These trials can be sponsored by government agencies such as the National Cancer Institute (NCI), by cancer centers at hospitals or universities, by pharmaceutical companies that research and develop new drugs or by a partnership of several organizations. Regardless of sponsorship, every clinical trial is subject to strict regulations and industry guidelines put in place to protect patients and ensure high-quality research data.

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A clinical trial can last for weeks, months or years, depending on the trial’s goal, the number of patients involved and the results. Most drugs have to pass through multiple phases of trials before being approved by the FDA.

“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.”

Claire Verschraegen, M.D., Director of Hematology/Oncology, University of Vermont Medical Center

Why Should I Participate?

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

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

Usually, a clinical trial results in an incremental improvement in patient outcomes, or it returns a negative result that convinces doctors to try different ideas. Sometimes, however, a trial leads to the sort of breakthrough every mesothelioma specialist hopes for, changing the way the medical community approaches cancer treatment.

For example, successful trials of immunotherapy are driving one of the biggest shifts in cancer treatment in decades. The U.S. Food and Drug Administration (FDA) has not yet approved immunotherapy specifically for mesothelioma patients, but many of the latest drugs are being offered to select pleural and peritoneal mesothelioma patients through clinical trials.

The stories of participants with mesothelioma attest to the life-changing potential of clinical trials.

How Do I Enroll in a Clinical Trial?

The U.S. National Institutes of Health (NIH) maintains a database of past and present clinical trials, and a mesothelioma specialist at a cancer center can also help you access new treatments. Talk to your doctor about whether a clinical trial is right for you.

A comprehensive listing of clinical trials for mesothelioma and other forms of cancer can be found at Clinicaltrials.gov.

Every clinical trial has specific criteria for who is eligible to participate. Some trials are only for patients who have not been treated before; other trials are exclusively for patients who did not respond well to standard treatments.

Factors Considered for Clinical Trial Eligibility

  • Age and gender of patient

  • Overall health of patient

  • Type and stage of mesothelioma

  • Patient’s past treatment history

  • Underlying medical conditions

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Clinical Trials Recruiting Mesothelioma Patients

Because mesothelioma is such a rare disease, with only 2,000 to 3,000 patients diagnosed annually in the United States, it is all the more important for as many mesothelioma patients as possible to participate in clinical trials. Dozens of trials are actively recruiting mesothelioma patients. A few of the most notable ones are reviewed below.

Quick Fact

“Participation of patients with mesothelioma in clinical trials is essential if we are going to make progress and develop novel therapies.” — Raffit Hassan, M.D., senior investigator at the NCI

Keytruda and CRS-207

In the summer of 2017, six cancer centers began recruiting patients for a phase II clinical trial involving a combination of two immunotherapy drugs: Pembrolizumab and CRS-207. Both drugs have already shown promising results individually in previous clinical trials.

Pembrolizumab, marketed as Keytruda, is a well-known immunotherapy agent already approved by the FDA for treating several types of cancer. CRS-207 uses genetically engineered Listeria bacteria to trigger an immune response to a specific tumor antigen.

To qualify for this treatment study, patients must already have received chemotherapy. The trial is expected to run through 2019.

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Nivolumab and Ipilimumab

On the heels of a promising 2016 clinical trial in France, 17 cancer centers around the world are now conducting a phase III clinical trial to test whether an immunotherapy drug combination produces better results than standard chemotherapy for unresectable pleural mesothelioma.

The drugs nivolumab (Opdivo) and ipilimumab (Yervoy) have already impressed researchers as second-line and third-line treatment options, and now hundreds of patients will have a chance to receive the immunotherapy regimen as a first-line treatment.

Newly diagnosed patients with unresectable disease are encouraged to participate in the trial, which is expected to last until 2021.

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Durvalumab

In 2017, a dozen cancer centers across the country began participating in a phase II clinical trial involving durvalumab, a promising immunotherapy drug already FDA-approved for the treatment of bladder cancer and lauded for its effectiveness in lung cancer clinical trials.

Durvalumab activates an immune system response against tumor cells that overexpress the PD-L1 protein, which is common in several cancers.

This is the first time researchers are testing a combination of durvalumab and standard chemotherapy as a first-line treatment for unresectable mesothelioma. To qualify for this trial, patients must not have received any other type of treatment.

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Anetumab Ravtansine

Following positive clinical trial results presented in 2016, several cancer centers are now testing the immunotherapy drug anetumab ravtansine as part of a first-line mesothelioma treatment regimen.

Anetumab ravtansine targets mesothelin, the tumor surface protein found in 85-90 percent of mesothelioma cancer patients. The new phase I trial will combine the novel drug with cisplatin and pemetrexed, the most common chemotherapy drugs used for treating mesothelioma.

The trial is expected to last a year, and it is open to pleural and peritoneal mesothelioma patients, as well as patients with non-small cell lung cancer.

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What Risks Are Involved?

Clinical trials always come with certain risks. The experimental treatment may not be as effective as anticipated, and you could experience unexpected side effects that harm your health.

To make the process as safe as possible for patients, the FDA structures clinical trials into four phases.

Phase I

A phase I trial involves the smallest number of people, perhaps only a few dozen participants, because it focuses on making sure the experimental therapy is safe. The goals are to analyze side effects, examine how the drug or procedure is processed by the body, and determine safe dosage levels.

Phase II

A phase II trial takes a closer look at just how effective the new treatment is, while still carefully calibrating the safety levels of the therapy. The trial population may include up to a few hundred patients.

Phase III

A phase III trial involves the largest number of people, potentially thousands of patients, and it measures the effectiveness of the new treatment versus the standard treatment approach. It also is used to finalize dosage amounts and document side effects.

Phase IV

After a drug successfully clears the first three phases of clinical trials, a drug developer can file an application to market the new drug. Even after the FDA has approved a new therapy, however, further phase IV trials may be required to ensure its effectiveness even after it has been approved for commercial use for specific indications.

Could I Get a Placebo?

Registered nurse Karen Selby explains how clinical trials benefit mesothelioma patients.

Not all clinical trial participants actually receive the new treatments being tested, but all cancer patients participating in a clinical trial do receive excellent medical care. You will not miss out on high-quality medical attention by participating in a clinical trial.

Many medical experiments divide participants into a test group and a control group. The test group receives the experimental treatment, while the control group does not.

  • In a clinical trial involving healthy patients, the control group might receive a fake version of the treatment, which is called a placebo.

  • In a trial for cancer patients, however, the control group will receive the standard cancer treatment appropriate for them.

Researchers are never allowed to intentionally withhold necessary medical care.

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 and Industry Funding

The 2017 budget for the NCI was about $5.3 billion, with many millions of dollars set aside for clinical trials of cancer treatments. In recent years, however, private industry funding of clinical trials has begun to dwarf direct government investment. Hospitals, universities and other research organizations also play a major role.

In the summer of 2017, there were 80 mesothelioma-related clinical trials listed on the NIH database, which can be divided into four categories based on funding source on the website.

Private donations may also help cover the cost 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

Costs for clinical trial participants may include transportation, doctor visits, hospital stays, laboratory tests, X-rays and scans.

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

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

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

  • The phase of the trial

  • The duration of the study

  • The risks involved with the trial

In many cases, transportation costs present the largest obstacle for mesothelioma patients who want to participate in a clinical trial. You may have to travel to a cancer center in another state and arrange for room and board while you are there. Cancer centers and charitable organizations offer grants to help with these expenses.

Questions to Ask Your 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.

View & Print These Questions to Ask About Clinical Trials

We’ve created a handy list of questions you can print and take with you. Getting answers to these concerns will help you decide if you should participate in a clinical trial.

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Karen Selby, RN and Patient Advocate at The Mesothelioma Center

Karen Selby joined Asbestos.com in 2009. She is a registered nurse with a background in oncology and thoracic surgery and was the director of a tissue bank before becoming a Patient Advocate at The Mesothelioma Center. Karen has assisted surgeons with thoracic surgeries such as lung resections, lung transplants, pneumonectomies, pleurectomies and wedge resections. She is also a member of the Academy of Oncology Nurse & Patient Navigators.

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Sources
  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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