Mesothelioma Clinical Trials

Quick Summary

Clinical trials test brand new mesothelioma treatments on real people. If you don’t respond to traditional mesothelioma therapies, clinical trials provide opportunities to try out new treatment strategies while contributing to the global scientific community.

New drugs and treatment strategies are clinically tested before receiving FDA approval. Before a treatment enters a trial phase, it’s tested in laboratories and on animals. These initial tests must have demonstrated promising results.

Mesothelioma clinical trials are believed to be reasonably safe and have significant potential for improving patient prognosis.

How to Find Clinical Trials

The best way to find clinical trials is to talk to your mesothelioma specialist or oncologist. He or she will be able to review any active and recruiting clinical trials and determine your eligibility. Your oncologist can also review the research of each clinical trial and help you decide which one is the right option for you.

Find a Clinical Trial

Contact a Mesothelioma Help Now Patient Advocate today for information on accessing clinical trials to improve your prognosis.

Request a Call from a Patient Advocate

The U.S. National Library of Medicine maintains a clinical trial database of public and private trials, which can be accessed by anyone at any time. You can search for clinical trials by status, condition, location and eligibility criteria to see if there are any current trials you may be able to participate in.

How to Join a Mesothelioma Clinical Trial

If you find a clinical trial that you’re interested in joining, there are 2 ways to do so:

  1. Talk to your doctor, who will help you review your eligibility and determine whether the clinical trial is a good option for your needs.
  2. Reach out to the clinical trial team to begin the recruitment process. Researchers will publish clear contact information so patients can contact them.

More About Clinical Trials For Mesothelioma

Types of Clinical Trials

There are 5 types of clinical trials, and any one of them may recruit mesothelioma patients:

  1. Prevention
  2. Screening and early detection
  3. Diagnostic
  4. Treatment
  5. Supportive care

Understanding each type of trial will help you decide whether a trial’s objectives align with your own, and can help you determine if it’s worth your participation.

1. Prevention

Prevention trials look for ways to reduce the risk of developing mesothelioma or prevent it from recurring. Because mesothelioma is a slow-growing cancer, prevention trials are focused on individuals who have previously been diagnosed with mesothelioma and are now in remission.

These studies may use certain drugs or chemotherapies, or they may investigate how certain lifestyle factors like smoking or eating well impact mesothelioma occurrence.

2. Screening and Early Detection

Screening trials attempt to find better ways to test and detect mesothelioma in earlier stages. Mesothelioma is notoriously difficult to diagnose early. However, a patient’s prognosis tends to be significantly better if the cancer is caught early on. Therefore, research into improving early detection and screening methods is a top priority for many mesothelioma specialists.

Screening trials for mesothelioma could review innovative imaging methods like tomography, biological markers that may lead to mesothelioma or advanced genetics.

3. Diagnostic

Diagnostic clinical trials seek improved ways to diagnose mesothelioma or determine its staging.

Diagnosing mesothelioma can be challenging, sometimes requiring surgical intervention to truly assess the cancer’s stage. Improved diagnostic tests will make it easier for oncologists and mesothelioma specialists to properly assess patients and develop appropriate treatment plans.

Diagnostic trials often attempt to make advancements in laboratory tests, or study new methods of retrieving biopsies (tissue samples) that can be used to make a diagnosis.

4. Treatment

Treatment trials make up the bulk of mesothelioma trials, focusing on new mesothelioma treatment options that may improve survival rates or quality of life. These treatments may include:

  • Surgery
  • Chemotherapy
  • Radiation therapy
  • Hormonal therapy
  • Biological or immunotherapy
  • Combinations of multiple therapies

Many current treatment trials are testing new drugs and chemotherapy combinations.

5. Supportive Care

Also called “quality of life trials,” supportive care trials try to reduce the negative impact that mesothelioma has on patients by improving their overall comfort. Supportive care trials may be developed around nutritional plans, psychological or social challenges, pain management or any other aspects of overall wellness.

Statuses of Mesothelioma Clinical Trials

Mesothelioma clinical trials use several statuses to indicate the progress of a trial, including:

  1. Not Yet Recruiting: The clinical trial has been announced, but participants are not being accepted yet.
  2. Recruiting: These clinical trials are currently looking for more participants. If you meet all of the requirements for a clinical trial that is marked “Active,” you may be able to join that trial. If you’re interested, talk to your doctor as a next step to help determine whether the clinical trial is right for you.
  3. Active — Not Recruiting: These trials are still in process, but new participants will not be able to join them. Because trials can take years to complete, it’s possible for a trial to be under this status for several years.
  4. Completed: Once the testing portion of a clinical trial is finished, the trial will be marked Completed. However, researchers may still take several months or even years to review the results of the clinical trial and compile their final reports. If you are interested in the research that comes from a clinical trial, make note of that trial’s “Study Completion Date.”

Clinical Trial Phases

Clinical trials go through several phases before a new treatment or drug can receive FDA approval:

  • Preclinical trial
  • Phase 0
  • Phase 1
  • Phase 2
  • Phase 3
  • FDA Approval
  • Phase 4

If the results of one phase are positive, the trial will move onto the next phase. A trial has to move through all four phases before a therapy will be considered for the general public, and the process often takes more than a decade.

Preclinical Trial

Preclinical trials are the early tests that researchers use to see how a specific therapy impacts human cells or animals and determine whether it is likely safe for humans. These tests are more advanced than ones used to determine if an idea is viable.

Phase 0

A Phase 0 trial is meant to determine how a drug will impact the human body. These trials typically accept only 10-15 people, who will receive low doses of the drug. These tests aren’t attempting to cure or treat a disease, but to determine what the body does when it receives the treatment.

Phase 1

Phase 1 clinical trials review the safety and best dosage of a treatment. This phase attempts to determine the best way to administer the treatment, the safest and highest dose that can be received, how the therapy impacts the body, and whether any side effects will occur. According to the American Cancer Society, Phase 1 clinical trials accept up to a few dozen participants.

Phase 2

Phase 2 trials review whether a treatment can effectively combat mesothelioma using the best dosage determined in Phase 1. Phase 2 trials typically include fewer than 100 people and attempt to find participants who didn’t respond well to other therapies.

Phase 3

Phase 3 trials build on the results found in Phase 2, typically beginning an experimental process called “randomization.” With randomization, participants are divided into two groups and researchers compare an experimental group that receives the therapy to a control group that receives standard mesothelioma treatments.

The majority of these trials don’t allow participants or even test administrators to know which patients are in the experimental group and which are in the control group.

Phase 4

Phase 4 trials attempt to learn more about the benefits and risks associated with a specific therapy after it has been approved for clinical use by the FDA. Phase 4 trials typically look into the long-term impacts of a treatment and review side effects.

FDA Approval

When a clinical trial demonstrates that a mesothelioma treatment is safe and effective, it will be submitted to the FDA for approval.

This extensive review will go through all of the research and determine whether a therapy can be administered to the public. The FDA approval process can take anywhere from a few months to several years.

Key Questions to Ask About Clinical Trials

Participating in a clinical trial is a significant commitment and you shouldn’t take the idea lightly. Before deciding whether to join a clinical trial, take the time to ask any and every question that comes to mind.

Every mesothelioma trial is going to have a different objective, and it’s important to fully understand what that goal is before you make a decision.

While some clinical trials are attempting to slow mesothelioma cells down or test new treatment options, others are building up informational databases through tissue samples, questionnaires or simple observation. It’s important that your goals align with those of a clinical trial.

How long will the trial run for?

Clinical trials can vary greatly in length. Some will last for a few months, and others will go on for years. Be honest about how much time you’re willing to commit to a trial. Remember that many trials don’t guarantee encouraging results, but you’ll still be expected to participate through to the end.

Where is the clinical trial located?

Each clinical trial has one or more administering hospital, and you’ll be expected to go to that hospital for each treatment and follow-up session. Participating in a trial several states away may seem exciting, but travel and expenses can quickly take their toll.

Find out where a clinical trial will be located and be realistic in what travel you can accommodate if your condition worsens before you sign up.

Will a clinical trial this limit my treatment options?

Many doctors look at mesothelioma trials as a last resort, but this isn’t always the case. Some late-stage clinical trials typically look for people who haven’t participated in any other treatment options. This allows doctors to examine how their treatment affects participants without having to factor in the effects of previous treatments.

If you are interested in clinical trials, have a frank conversation with your mesothelioma specialist about what other treatment options are available.

Clinical Trial Payment Options

Most clinical trials don’t require payment from their participants. The cost of running a clinical trial is covered by the sponsoring public or private hospital.

Government organizations, like the National Cancer Institute (NCI), sponsor clinical trials in hopes of curing cancer. The federal government allocates an annual budget to the NCI, to improve the health of American citizens.

Non-profit organizations also sponsor clinical trials, which are typically funded by donors and through organizations like the American Cancer Society.

Many organizations are willing to sponsor clinical trial participation for individuals when financial barriers would otherwise restrict their ability to join.

However, these sponsorships may not cover all the medical costs you could face.

If you’re concerned about the cost of care, talk to your doctor. You may be entitled to financial compensation to cover the costs of treatments. Talk to our of our Patient Advocates today to find out more about your eligibility for financial compensation.

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Sources
  1. National Cancer Institute. “Steps to Find a Clinical Trial.” Retrieved from https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/trial-guide. Accessed on January 6, 2018.
  2. Canadian Cancer Society. “Types of Clinical Trials.” Retrieved from http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/clinical-trials/types-of-clinical-trials/?region=on. Accessed on January 6, 2018.
  3. Canadian Cancer Society. “Phases of Clinical Trials.” Retrieved from http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/clinical-trials/phases-of-clinical-trials/?region=on. Accessed on January 7, 2018.
  4. American Cancer Society. "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. Accessed on April 19, 2019.
  5. U.S. Food and Drug Administration. "Step 4: FDA Drug Review." Retrieved from https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405570.htm. Accessed on April 19, 2019.
  6. National Cancer Institute. "Paying for Clinical Trials." Retrieved from https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying. Accessed on April 19, 2019.

Last modified: April 19, 2019