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Clinical Trials for Pleural Mesothelioma

Pleural mesothelioma clinical trials test new cancer treatments for safety and efficacy. Learning the basics about these research studies can help patients decide if a clinical trial is right for them.

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Standard therapies for pleural mesothelioma include surgery, radiation therapy and chemotherapy. These options help control the disease, but do not offer a cure.

This leads many patients to seek out a clinical trial as part of their treatment plan.

Access to cutting-edge treatments such as immunotherapy may help some pleural mesothelioma patients live for years after diagnosis.

What Is a Clinical Trial?

A clinical trial is any research study that assigns people or groups of people to different treatments and evaluates how these options affect health-related outcomes.

Trials can study drugs, surgical procedures, radiation or chemotherapy, devices or other interventions.

For pleural mesothelioma, clinical trials test new options that may better control the disease. They may offer pleural mesothelioma patients the best opportunity for better quality and length of life.

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Types of Clinical Trials

There are several types of clinical trials, known as phases.

Phase 0

The main purpose of phase 0 clinical trials is to speed up and streamline the drug-approval process.

For example, this type of study helps determine if drugs do what’s expected. If a drug isn’t absorbed as expected or acts differently in the body than in the lab, a phase 0 trial will uncover this.

Phase 0 studies typically have fewer than 15 participants. Doses are low, so there is less risk to patients than later clinical trial phases.

However, lower doses also mean there’s less chance of benefit for the volunteer. Future patients may benefit from the information gathered from phase 0 trials.

Phase I

Phase I studies test the safety, side effects, best dose and optimal timing of a new treatment.

The doctors increase the dose a little at a time to determine the maximum tolerated dose: The highest dose of a drug or treatment that does not cause unacceptably harmful side effects.

While the goal of phase I studies is not to shrink tumors or cure patients, people sometimes experience significant benefit from the therapies.

Phase II

The aim of phase II studies is to determine whether a new treatment works for certain types of cancer.

Researchers look for an objective response. For example, did a tumor stop growing or shrink, or did blood test results improve?

Because phase II trials include more people, study investigators gather as much information as possible regarding safety of a new treatment.

Phase II trials do not compare new therapies against established treatments.

Phase III

The purpose of phase III clinical trials is to determine if a new treatment is better than existing therapies, called standard of care.

In pleural mesothelioma phase III clinical trials, people are never randomized to placebo or “no treatment.”

They will receive either the best available therapy for pleural mesothelioma or a new treatment option.

Phase IV

For some drugs, the FDA requires further study and trials, referred to as Phase IV.

This phase ensures the treatment is as effective as expected for specific indications.

Why Are Clinical Trials Important to Pleural Mesothelioma Patients?

Existing treatments for pleural mesothelioma can help control the disease, but they do not offer a cure.

A clinical trial may be a good option if your cancer continues to progress after standard-of-care treatment.

It can provide the opportunity to try new medical options that may offer continued disease control and improved quality and length of life.

Clinical trial participation also provides the cancer community and scientific researchers insight in how to defeat the disease.

Even if a participant does not directly benefit from a new clinical trial therapy, the information learned from their participation can help future patients.

Sometimes clinical trials create breakthroughs in how cancer is treated. This can provide hope and a sense of purpose to people diagnosed with pleural mesothelioma.

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How Can I Find a Clinical Trial?

The following steps can help you find pleural mesothelioma clinical trials.

How Can I Participate?

Before you can participate in a clinical trial, you need to determine if you are eligible.

Eligibility criteria include things such as age, cancer cell type, extent of your disease, other health conditions, and previous treatments received for pleural mesothelioma.

These criteria help ensure people are healthy enough to receive the planned treatment with acceptable risks. Clinical trial researchers do not want to make people sicker than they are or worsen existing health conditions significantly.

For example, if a person has a kidney condition, and the drug being tested requires good kidney function to keep toxicity low, they may not be eligible to participate.

Every clinical trial includes inclusion or eligibility criteria and things that would exclude a person from taking part in the study. You can read about this when you find clinical trials online.

If you have questions about your eligibility, you can contact the study investigators to ask them directly.

Your own doctor also can help you determine if you are eligible for a particular pleural mesothelioma clinical trial.

What Do Clinical Trials Cost?

The costs to the patient can vary from trial to trial. Many drugs or procedures are provided free to participants.

However, the patient may have to pay for costs related to transportation to and from the clinical trial site, doctor visits, scans, laboratory tests, hospital stays, and additional medications needed that are not part of the trial.

Some health insurance plans cover these costs and others do not.

Determining Costs and Financial Resources for Clinical Trials


Snehal Smart, M.D.

Snehal Smart, M.D.

Snehal Smart is the Pleural Mesothelioma Center’s in-house medical doctor, serving as both an experienced Patient Advocate and an expert medical writer for the website. When she is not providing one-on-one assistance to patients, Dr. Snehal stays current on the latest medical research, reading peer-reviewed studies and interviewing oncologists to learn about advancements in diagnostic tools and cancer treatments.

Medically Reviewed By Dr. Joanne Getsy
Last Modified February 11, 2019

7 Cited Article Sources

  1. World Health Organization. (2018). Health Topics. Clinical Trials. Retrieved from https://www.who.int/topics/clinical_trials/en/
  2. National Cancer Institute. (n.d.). NCI Dictionary of Cancer Terms. Phase I clinical trial. Retrieved from https://www.cancer.gov/publications/dictionaries/cancer-terms/def/phase-i-clinical-trial
  3. National Cancer Institute. (n.d.). NCI Dictionary of Cancer Terms. Maximum tolerated dose. Retrieved from https://www.cancer.gov/publications/dictionaries/cancer-terms/def/maximum-tolerated-dose
  4. U.S. National Library of Medicine. (2017, January). Learn About Clinical Studies. Retrieved from https://clinicaltrials.gov/ct2/about-studies/learn#ClinicalTrials
  5. National Cancer Institute. (n.d.). NCI Dictionary of Cancer Terms. Phase II clinical trial. Retrieved from https://www.cancer.gov/publications/dictionaries/cancer-terms/def/phase-ii-clinical-trial
  6. American Cancer Society. (2017, February 17). What Are the Phases of Clinical Trials? Retrieved from https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html
  7. National Cancer Institute. (2016, June 23). Steps to Find a Clinical Trial. Retrieved from https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/trial-guide

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