Mesothelioma Clinical Trials

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Mesothelioma clinical trials are research studies that test the safety and effectiveness of new medical treatment on people with the disease. These cutting-edge treatments explore new ways of treating, preventing or diagnosing mesothelioma. Many mesothelioma clinical trials are sponsored by NCI, mesothelioma centers and other reputable cancer groups who are helping advance the science of cancer treatment.

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Dr. David Sugarbaker, a pioneer of mesothelioma treatment, explaining the three phases of mesothelioma clinical trials.
Dr. David Sugarbaker, a pioneer of mesothelioma treatment, explaining the three phases of mesothelioma clinical trials.

What are Mesothelioma Clinical Trials?

Clinical trials for mesothelioma are controlled studies on people that test whether a new therapy approach is safe, effective and better than existing therapies.

Government agencies, cancer centers, pharmaceutical companies or a partnership of several organization s sponsor the clinical trials. Every mesothelioma clinical trial is subject to strict regulations and industry guidelines.

A mesothelioma clinical trial can last 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.

By participating in a mesothelioma clinical trial, you give yourself a chance to receive the best treatment available. You also help future patients by providing valuable information and feedback.

Mesothelioma Clinical Trials Actively Recruiting Patients

The U.S. National Institutes of Health (NIH) maintains a database of past and present clinical trials for mesothelioma. 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.

Dozens of clinical trials are recruiting mesothelioma patients. The following are some of the most notable trials.

CAR T-Cell Therapy

This phase 1 trial is testing a novel immunotherapy known as CAR T-cell therapy. It involves modifying a patient’s own T cells in a laboratory to help the cells better recognize cancer.

Patients provide a blood sample from which their own T cells are extracted. Once the cells are modified and multiplied in a lab, they are reintroduced back into the patient’s body. Patients often undergo chemotherapy to make space for the new increased amount of T cells, which continue to multiply in the body.

Early results indicate a number of participants are experiencing significant tumor shrinkage.

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Raffit Hassan M.D. Senior investigator at the NCI

“Participation of patients with mesothelioma in clinical trials is essential if we are going to make progress and develop novel therapies.”

Durvalumab and Tremelimumab

This phase 2 trial involves these two promising immunotherapy drugs. Durvalumab is already FDA-approved for the treatment of bladder cancer and praised for its effectiveness in lung cancer clinical trials. Tremelimumab has not been approved by the FDA.

Durvalumab activates an immune system response against tumor cells. It targets cells that overexpress the PD-L1 protein, which is common in several cancers. Tremelimumab is an immune checkpoint inhibitor that stimulates the immune system’s killer T cells to fight cancer.

This is the first time researchers are testing a combination of durvalumab and tremelimumab in mesothelioma patients who qualify for surgery.

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Keytruda and 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. Mesothelin is a tumor surface protein found in 85-90 percent of mesothelioma cancer patients. The new phase 1/2 trial will combine the novel drug with or without Keytruda.

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How Do I Enroll in a Mesothelioma Clinical Trial?

Most patients enroll in trials at the recommendation of their doctor, who generally knows which clinical trials you may be eligible to join.

Every mesothelioma 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.

Steps to Enroll in a Clinical Trial

Step 1: Talk to Your Doctor

Your oncologist can recommend clinical trials tailored to your diagnosis.

Step 2: Get a Second Opinion

Seeking a second opinion from a mesothelioma specialist may open the door to other clinical trials.

Step 3: Which Trials Interest You?

Take the time to deeply understand the trials that seem the most appealing to you.

Step 4: Ask Questions and Finalize Your Decision

Ask your doctor as many questions as necessary to understand the risks and benefits of the trial. Once you’ve finalized your decision, your medical team will walk you through necessary paperwork to join the trial.

Eligibility Factors

  • 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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Cost of Clinical Trials

Patients cover standard-of-care expenses. Government agencies or pharmaceutical companies typically absorb the majority of the costs involving the experimental drug.

For example, if a clinical trial for mesothelioma is investigating a new immunotherapy drug in combination with standard-of-care chemotherapy, the participant will pay for the chemotherapy and the trial sponsor will pay for the experimental immunotherapy drug.

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.

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

Factors Affecting Insurance Coverage

  • The phase of the trial
  • The duration of the study
  • The risks involved with the trial

In many cases, transportation costs present a large obstacle. 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.

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Understanding Side Effects of New Treatment

One of the potential risks of joining a clinical trial for mesothelioma is experiencing side effects from an experimental therapy.

For example, a number of mesothelioma clinical trials are investigating new immunotherapy drugs. Part of the risk of trying a new immunotherapy drug is experiencing side effects such as vision problems or a skin rash.

Many side effects are controllable and respond well to medication, especially when treated quickly.

However, some could become serious. For example, some immunotherapy patients develop inflammation of the bowel, or colitis.

Thankfully, most serious side effects are reversible, except for hormone gland damage. If the pituitary, thyroid or adrenal glands are damaged the effects may be permanent and may require lifelong management with medication.

Are Mesothelioma Clinical Trials Safe?

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

To make the process as safe as possible for patients, the U.S. Food and Drug Administration structures clinical trials into four phases.

Phase I

A phase I trial involves the smallest number of people, perhaps only a few dozen participants. 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 how effective the new treatment is, while determining the safest dosage or technique 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, sometimes thousands of patients. It measures the effectiveness of the new treatment versus the standard treatment approach. It also finalizes dosage amounts and documents side effects.

Phase IV

After a drug clears the first three phases, a drug developer can file an application to market the new drug. Even after the FDA has approved a new therapy, a phase IV trial may be required. This phase ensures effectiveness after approval for commercial use for specific indications.

Questions to Ask Your Doctor Before Participating

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. Also ask about other treatment options available, costs and possible side effects.

View & Print These FAQs 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.

Are Placebos Used in Cancer Clinical Trials?

Placebos are not common in cancer clinical trials. 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 care by participating in a clinical trial.

Registered nurse Karen Selby encourages patients to look into mesothelioma clinical trial options.

Many medical experiments separate 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 placebo, which is an inactive version of the treatment.
  • In a trial for cancer patients, the control group will receive the standard cancer treatment appropriate for them.

Researchers are never allowed to intentionally withhold necessary medical care.

Clinical Trials Lead to New Treatment & Survivor Stories

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

There is no cure for mesothelioma. Doctors are researching new therapies to improve survival rates and quality of life.

Sometimes a trial leads to a breakthrough that changes the way doctors approach cancer treatment. For example, one trial led to the only FDA-approved therapy for mesothelioma.

Chemotherapy Trial of Cisplatin and Alimta

In 2003, one of the most important mesothelioma clinical trials announced its success treating patients with a combination of the chemotherapy drugs Alimta (pemetrexed) and cisplatin. The combination therapy was approved to treat pleural mesothelioma by the FDA in 2004.

To date, it is the only FDA-approved treatment for mesothelioma. Other trials have worked well for certain mesothelioma patients, but not well enough for a large number of patients to receive FDA approval.

This emphasizes the importance of patient participation. Many mesothelioma trials struggle to get enough participants to truly test a new drug or therapy. Joining a trial helps researchers get closer to developing a cure.

Survivor Stories

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

Kathy Angerman, Mesothelioma Survivor

Kathy

Mesothelioma Survivor

Kathy A. joined a clinical trial in 2013 that halted the growth of her tumors for six months. In 2014, she underwent chemotherapy but had to stop after a year because of side effects. Now she’s looking for another clinical trial to join.

“I’m not sure what I’m going to do if or when the doctor tells me the cancer is growing again,” Angerman said. “That’s why I wanted to find another clinical trial. Chemotherapy alone isn’t the answer.”

Richard M., Mesothelioma Survivor

Richard M.

Mesothelioma Survivor

Richard M. joined an immunotherapy clinical trial in 2012 after his surgery for pleural mesothelioma. He believes the immunotherapy trial helped extend his survival, although now he copes with reduced stamina.

“I want to be as helpful as I can,” Richard said. “Being in a clinical trial has allowed me to do that, providing information to researchers about therapies that could help patients in the future. Sure, I was hoping it could help me, but it’s also rewarding when you know you’re helping others, which is what a clinical trial does.”

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Registered Nurse and Patient Advocate

Karen Selby joined Asbestos.com in 2009. She is a registered nurse with a background in oncology and thoracic surgery and was the regional 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.

Walter Pacheco, Managing Editor at Asbestos.com
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Last Modified June 13, 2019

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