Mesothelioma Doctors: We Need More Patients in Clinical Trials

Research & Clinical Trials
Reading Time: 7 mins
Publication Date: 09/19/2012
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One of the most important steps any cancer patient can take — especially for a mesothelioma cancer patient — is the step into a clinical trial, a leap of faith that goes well beyond one’s own best interest.

It’s what makes progress possible. It’s what creates optimism for the future. It’s what fuels the engine of hope.

And ultimately, it’s what can define a cancer patient.

“The first reaction, sometimes, from a patient when we talk about being in a clinical trial, is they say,`You want me to be a guinea pig?’ ” said Claire Verschraegen, M.D., director of the Hematology/Oncology Division at the University of Vermont Medical Center, in an interview with
“And I say, `No, no, 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. And that’s what these patients are doing.”

Like so many oncologists, surgeons and researchers around the country, Verschraegen believes patients in clinical trials are the real heroes in this ongoing fight to find better treatment options, improve therapies, and eventually find cures for all cancers.

Unfortunately, not enough patients participate in clinical trials. The lack of participants is one reason the progress with cancer often has been slow, especially for a rare cancer like mesothelioma.

5-Percent Participation for Cancer Trials

According to The National Cancer Institute, less than 5 percent of all cancer patients in the United States are part of a clinical trial. And while two-thirds of all cancer patients are 65 years or older, this group represents less than one-third of all clinical trial participants.

Clinical trials are research studies that involve people. Each has a distinct, well-focused purpose. Studies can be categorized into treatment, prevention or screening. They allow patients to contribute to the knowledge of scientists and doctors who deal with cancer.

They can be sponsored by government agencies like the National Cancer Institute (NCI), by Cancer Center Programs with NCI support, by Community Clinical Oncology Programs, which make trials available in a large number of communities, or by Specialized Programs of Research Excellence, which brings scientists and researchers together with patients.

“For studies to produce meaningful results, you need a large number of people involved, which is why it’s so important for patients to participate if given the opportunity,” Cary Gross, M.D., associate professor of medicine at Yale University and co-director of the Robert Wood Johnson Foundation Clinical Scholars Program, said during a recent interview. “And it’s critical for a rare cancer like mesothelioma. If you’re only getting five of 100 patients participating, it’s going to slow down the testing of new treatments.”

Many Clinical Trials Slots Unfilled

There are 164 clinical trials involving different levels of malignant mesothelioma research in 2012. They are either recruiting participants, actively testing participants or just recently finished, according to the United States National Institutes of Health (NIH). Yet within the ongoing trials, many slots remain unfilled.

Many involve the testing of new drugs that scientists hope can combat the cancer.  Among the treatments being tested in clinical trials – and with considerable early success – are gene therapy, which uses laboratory modified viruses, and immunotherapy, a technique that manipulates a patient’s immune system into attacking cancerous cells.

“Participation 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 National Cancer Institute, which is part of NIH.

Many patients go into a trial with the hope that it will improve their survival time against a cancer with no cure. Other participants volunteer purely for altruistic reasons. They understand that progress can’t be made unless new drugs and therapies can be tested. Trials come with no guarantees.

“There are many whose main reason for enrolling is that they believe there is a chance it could help them significantly. Sometimes it helps them, and sometimes it doesn’t,” Gross said. “But there also is a large number in the trials who know they are helping others. That’s why they are there. I’ve had people tell me, `The one good thing that can come out of me getting cancer is that I can help those who come after me.’ I think the split is pretty even.”

Nobody Asking Patients to Participate

Researchers believe there are several reasons why the percentage of cancer patients who participate in a clinical trial is so low. There often are costs involved that aren’t always covered by private insurance or by Medicare, although the majority of states now require insurance companies to cover clinical trials.

Older patients sometimes have little interest if it requires travel. Too often, patients are not always aware of the availability of a trial, which is partly the fault of the local oncologist they are seeing.

“One study looked at the main reason why, and the response was they never were asked to be part of one,” Gross said. “One of the biggest barriers we often face is that local doctors are not always aware of them, or they don’t encourage the patient to participate. I do know that getting more people to participate (in trials) would absolutely help the fight (against cancer).”

The low percentage of participants is magnified with mesothelioma, which is diagnosed in only 2,000 to 3,000 Americans a year. It is caused by an exposure to asbestos, and has a latency period of 10 to 50 years. Too often, it is not diagnosed until it already has spread, leaving the patient with a feeling of hopelessness.

“Mesothelioma is a rare disorder and requires a greater proportion of the affected population to participate in trials,” said Jill Ohar, M.D., professor of medicine at Wake Forest University, who has a particular interest in how genetics affect mesothelioma. “You need sufficient statistical power to make sense of the data. These therapies (some of which are in trials) have the potential to revolutionize the way we care for cancer patients by providing a mechanism to prevent or slow the recurrence of disease.”

Patients ‘Need to Be Bold’

The standardized care for mesothelioma today that includes a two-drug combination of cisplatin and alimta, replaced the earlier single-drug treatment, primarily because of results from a clinical trial a decade ago.

“Mesothelioma patients need to be bold. . . . Clinical trial participation is the life blood of progress in treating mesothelioma,” wrote Nicholas Vogelzang, M.D., former Board Chairman of the Mesothelioma Applied Research Foundation and noted cancer research specialist. “They and their physicians need to push the boundaries and invest in the future by joining and demanding that clinical trials be available.”

The potential benefit of clinical-trial participation, in addition to the altruistic side, is that it might be the only avenue a patient has to get the latest, most up-to-date treatment option. The potential risks could include an untested drug that just doesn’t work, or side effects that were not anticipated.
“If we keep using the same treatments, we’ll never find a better one,” Verschraegen said. “If you do nothing, no progress will be made. Patients usually  hope the newest one works better. They are heroes for trying, because even if it doesn’t help them, it helps those that follow.”

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