Alternative Treatments & Clinical Trials

Across the United States and around the world, doctors and researchers are working hard to find better treatments and – hopefully one day – a cure for mesothelioma. As developments are made in mesothelioma research, alternative treatment options make their way to the market through clinical trials. Researchers for mesothelioma clinical trials need to test their treatments on real patients to determine whether they’re effective, and that’s where you come in. Talk to your doctor and medical team about whether a mesothelioma clinical trial might be an option for you.

What is a clinical trial, and is it right for me?

The National Cancer Institute describes clinical trials as “the final step in a long process” that starts with a lot of research in a laboratory and tests on animals. The clinical trial portion of the process involves testing the treatment on real human patients to determine whether or not it is effective and safe. The hope is always that the treatment will help the patients, but there is a risk that it could be harmful or have no effect.

Mesothelioma clinical trials may include a variety of treatment options, and not all patients who participate will be trying a brand-new treatment. As ClinicalTrials.gov explains, trials may include:

  • Testing new drugs or medical devices
  • Trying new medical procedures
  • Experimenting with changes to patients’ behavior, such as diet
  • Comparing a new medical approach to a standard one
  • Comparing a new treatment to a placebo (which contains no active ingredients)
  • Comparing two treatments that are already available

Talk to your doctor and medical team about the potential risks and rewards of participating in a mesothelioma clinical trial. Also consider talking to other patients who have participated in mesothelioma clinical trials and research to get their perspectives.

Who pays for clinical trials? Are there costs for patients?

In most cases, patients do not pay to participate in the mesothelioma clinical trials themselves. The costs of the research done in the clinical trial are often covered by the government, nonprofit agency, or company that is sponsoring the mesothelioma clinical trial, according to the National Cancer Institute.

However, patients may still be on the hook for routine medical costs that they would have incurred even if they were not participating in a clinical trial, such as regular doctor visits and exams. The National Cancer Institute warns that patients should check with their insurance plans before participating in a mesothelioma clinical trial because some plans won’t cover routine medical costs if a patient is part of a trial. Patients also need to take into account the potential expense of traveling and lodging during a mesothelioma clinical trial.

What are the phases of a mesothelioma clinical trial?

The Food and Drug Administration (FDA) oversees the approval process for medical treatments in the United States. Once a drug has been developed and tested on animals, the drug’s sponsor submits an application to the FDA to start the clinical trial process, which includes four phases:

Phase 1: About 20 to 80 healthy people are usually chosen for phase 1 of a clinical trial, where the goal is to identify common side effects and how the drug is metabolized and excreted. This phase focuses on safety.

Phase 2: Hundreds of people are chosen to participate in phase 2 of a clinical trial, which focuses on the treatment’s effectiveness. In this phase, participants with mesothelioma receive the treatment and, in many cases, the effectiveness will be measured against other patients who are receiving a placebo or different treatment.

Phase 3: At this stage, the clinical trial is expanded to include even more participants. The goal is to study the safety and effectiveness among various populations, using different dosages and testing the drug in combination with other drugs.

Phase 4: This phase actually occurs after the FDA has approved a drug for marketing. Doctors and patients continue to report side effects, and the sponsor (which is usually the manufacturer of the drug) is required to provide updates to the FDA as new information about the drug’s effects is discovered.

How can I qualify for a mesothelioma clinical trial?

If you are interested in participating in a mesothelioma clinical trial, start by talking to your doctor about your options. You will first need to know specific details about your mesothelioma diagnosis that you can compare to the eligibility criteria for any trials you are interested in. The National Cancer Institute offers a Cancer Detail Checklist that you and your medical team can fill out to get started.

When looking for mesothelioma clinical trials, there is no one-stop shop that lists them all. Trials can be sponsored by the government, nonprofit agencies, pharmaceutical companies, and medical centers with researchers on staff. However, here are a few good places to start your search:

When you find a mesothelioma clinical trial that you are interested in, the National Cancer Institute suggests you print a copy of the clinical trial summary, which should explain the basic details of the trial and where it is taking place.

What questions should I ask my doctor?

You should always learn as much as you can about a mesothelioma clinical trial before deciding whether to participate in it. You have a right to ask your doctor and the research team about all aspects of the study, the medications or procedures involved, and any related expenses.

ClinicalTrials.gov suggests that patients ask the following questions when considering participating in a clinical trial:

  • What exactly is being studied, and what will I have to do?
  • What tests and procedures are involved?
  • How often will I have to visit the hospital or clinic? Will hospitalization be required?
  • Why do researchers think the intervention being tested might be effective? Why might it not be? Has it been tested before?
  • How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
  • What are the possible interventions that I might receive during the trial? And how will that be determined (for example, by chance)?
  • Who will oversee my medical care while I am participating in the trial?
  • What will happen if I am injured during the study?
  • How long will the study last?
  • Who will pay for my participation? Will I be reimbursed for other expenses such as travel?
  • If I benefit from the intervention, can I continue receiving it after the trial ends?
  • What type of long-term follow-up care is part of this trial?
  • Will results of the study be provided to me?

Finding Hope Through Mesothelioma Research

Whether you’ve just been diagnosed with mesothelioma or are well into your treatment journey, know that doctors and researchers are constantly searching for more and better alternative treatment options through mesothelioma clinical trials. And remember, most of the effective treatments we take for granted today were first tested in clinical trials.

For a free mesothelioma care guide and information kit, contact us today.

Below is a list of current mesothelioma clinical trials. You can find additional trials by searching on mesothelioma at National Cancer Institute’s clinical trials website, which you can access by clicking here:http://www.clinicaltrials.gov/ct/screen/SimpleSearch

Do Your Genes Put You at a Higher Risk of Developing Mesothelioma
Condition: Mesothelioma
Intervention: Not Provided
Sponsors: Wake Forest School of Medicine
Completed: December 2014 (final data collection date for primary outcome measure)

Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.
Condition: Malignant Pleural Mesothelioma
Intervention: Biological: HSV1716 Intra-pleural delivery
Sponsors: Virttu Biologics Limited
Completed: June 2015 (final data collection date for primary outcome measure)

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
Condition: Mesothelioma
Interventions: Drug: Pentostatin;   Drug: Cyclophosphamide;   Biological: SS1(dsFv)PE38
Sponsors: National Cancer Institute (NCI)
Completed: April 2016 (final data collection date for primary outcome measure)

Dendritic Cells Loaded With Allogeneous Cell Lysate in Mesothelioma Patients
Condition: Mesothelioma
Intervention: Biological: MesoCancerVac
Sponsors: Erasmus Medical Center
Completed: December 2015 (final data collection date for primary outcome measure)

Alisertib in Malignant Mesothelioma
Conditions: Lung Cancer;   Mesothelioma
Intervention: Drug: Alisertib
Sponsors: M.D. Anderson Cancer Center
Completed: May 2021 (final data collection date for primary outcome measure)

Response Evaluation in Malignant Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma
Intervention: Not Provided
Sponsors: Istituto Clinico Humanitas (Italy)
Completed: May 2015 (final data collection date for primary outcome measure)

Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
Conditions: Recurrent Malignant Mesothelioma;   Stage IA Malignant Mesothelioma;   Stage IB Malignant Mesothelioma;   Stage II Malignant Mesothelioma;   Stage III Malignant Mesothelioma;   Stage IV Malignant Mesothelioma
Interventions: Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter;   Other: laboratory biomarker analysis;   Procedure: single photon emission computed tomography;   Procedure: computed tomography
Sponsors: Mayo Clinic
Completed: December 2016 (final data collection date for primary outcome measure)

Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy
Condition: Malignant Mesothelioma
Interventions: Drug: pemetrexed disodium;   Other: clinical observation
Sponsors: Cancer and Leukemia Group B
Completed: December 2015 (final data collection date for primary outcome measure)

PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
Condition: Mesothelioma
Intervention: Radiation: Prophylactic Irradiation of Tracts (PIT)
Sponsors: Colin Lunt
Completed: May 2017 (final data collection date for primary outcome measure)

ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)
Condition: Malignant Pleural Mesothelioma
Intervention: Drug: Trabectedin
Sponsors: Mario Negri Institute for Pharmacological Research
Completed: October 2015 (final data collection date for primary outcome measure)

Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma
Interventions: Biological: Vaccine plus chemotherapy;   Biological: Vaccine with cyclophosphamide plus chemotherapy
Sponsors: Aduro BioTech, Inc.
Completed: December 2015 (final data collection date for primary outcome measure)

Window of Opportunity Study of VS-6063 (Defactinib) in Participants With Surgical Resectable Malignant Pleural Mesothelioma.
Condition: Malignant Pleural Mesothelioma
Intervention: Drug: VS-6063
Sponsors: Verastem, Inc.
Completed: November 2015 (final data collection date for primary outcome measure)

Pembrolizumab in Treating Patients With Malignant Mesothelioma
Conditions: Biphasic Mesothelioma;   Epithelioid Mesothelioma;   Peritoneal Malignant Mesothelioma;   Pleural Biphasic Mesothelioma;   Pleural Epithelioid Mesothelioma;   Pleural Malignant Mesothelioma;   Pleural Sarcomatoid Mesothelioma;   Recurrent Peritoneal Malignant Mesothelioma;   Recurrent Pleural Malignant Mesothelioma;   Sarcomatoid Mesothelioma
Interventions: Biological: Pembrolizumab;   Other: Laboratory Biomarker Analysis;   Other: Pharmacogenomic Study
Sponsors: University of Chicago
Completed: March 2018 (final data collection date for primary outcome measure)