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 the opportunity to try out new treatment strategies, while contributing to the global scientific community.

Mesothelioma Clinical Trials

Pharmaceuticals, new strategies, and experimental treatments go to clinical trial as the last step before receiving FDA approval. Before a treatment can become a clinical trial, it is tested in laboratories and on animals, and must have demonstrated promising results. Mesothelioma clinical trials conducted for new treatment options 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 each clinical trial is based on and help you decide whether it’s the right option for you.

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 two 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. Because clinical trials want active participants, they tend to publish clear contact information. You are welcome to use this contact info to reach out to any clinical trial team to begin the recruitment process.

More About Clinical Trials For Mesothelioma

Types of Clinical Trials

There are five types of clinical trials, and any one of them may recruit mesothelioma patients. 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.

Prevention: Prevention trials try to find ways to reduce the risk of developing mesothelioma or prevent it from recurring. Because mesothelioma is such 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.

Screening and Early Detection: Screening trials attempt to find better ways to test and detect mesothelioma in earlier stages. Mesothelioma is notoriously difficult to diagnosis early, yet patient prognosis tends to be significantly more positive the earlier it’s detected. 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.

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 test new imaging techniques, attempt to make advancements in laboratory tests, or biopsy new tissue samples to be used by mesothelioma tissue labs.

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, or a combination of multiple therapies. Many current mesothelioma treatment trials are testing new pharmaceutical drugs and chemotherapy cocktails.

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 number of other aspects of overall wellness.

Statuses of Mesothelioma Clinical Trials

Mesothelioma clinical trials use three statuses to indicate the progress of a trial. These statuses are as follows:

Recruiting: Recruiting 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.

Active: Not Recruiting: Trials that are active but not recruiting are currently underway are marked “Active – Not Recruiting.” In some circumstances, these trials will welcome additional participants, but this is not a common occurrence. Because trials can take years to complete, it’s possible for a trial to be under this status for several years.

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. 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 initial 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 the ones used in initial laboratory tests 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. Not all clinical trials start in Phase 0, but it is common.

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.

Participants are typically divided into several cohorts of 2-6 people, with each cohort receiving a different dose of the drug so researchers can compare and contrast the body’s reactions.

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 does not. The majority of these trials don’t allow participants or even test administrators to know whether an individual is in the experimental group or the control group. Phase trials may or may not allow participants who have previously tried other treatments.

Phase 4

Phase 4 trials attempt to learn more about the benefits and risks associated with a specific therapy, often after it has been approved for clinical use. Phase 4 trials typically look into the long-term impacts of a treatment and review side-effects. Note that not all approved treatments require Phase 4 trials.

FDA Approval

If the clinical trials demonstrate 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.

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, including the following:

Every mesothelioma trial is going to have a different objective, and it’s important to fully understand what that 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, but most mesothelioma trials last a minimum of 6 months. Be honest about how much time you’re willing to commit to this trial. Remember that many trials don’t have favorable or 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.

How will this limit my treatment options?

Many doctors look at mesothelioma trials as a last resort, but this isn’t always a requirement. Instead, late-stage clinical trials typically look for people who haven’t participated in any other treatment options to ensure their trial is the only thing impacting your health. If you are interested in clinical trials, have a frank conversation with your mesothelioma specialist about what other treatment options you’ll be passing up.

Clinical Trial Payment Options

Most clinical trials don’t require payment from their participants. Instead, the cost of running a clinical trial is covered by the public or private entity that’s sponsoring the trial.

Some government organizations, like the National Cancer Institute, will sponsor clinical trials in hopes of curing cancer. The federal government allocates an annual budget to the NCI, in the interest of improving the health of American citizens.

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

Private or for-profit organizations may also sponsor clinical trials. These organizations do so in hopes of developing a drug or treatment tool that will be profitable for their company.  As you can imagine, discovering an improved treatment or the cure for cancer would be extremely lucrative for the sponsoring company.

If the cost of a clinical trial is not already covered by a government, non-profit or for-profit organization, talk to your doctor. Many organizations are willing to sponsor clinical trial participation for individuals when financial barriers would otherwise restrict their ability to join.

Have you been diagnosed with mesothelioma? 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.

View Author and Sources
Author

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.

Last modified: February 2, 2018