Is a Clinical Trial Right for Me?

Today’s Moderator:Dana Nolan, MS LMHC

Licensed Mental Health Counselor

Clinical Trials in Mesothelioma Care

Common misconceptions about clinical trials that keep patients from considering participating: Clinical trials are only offered when hope is lost.The experimental medicines or treatments can

cause more harm than good.Fear getting a “sugar pill” and that they aren’t

receiving any treatment.Once you start a clinical trial, you can’t stop it.It is not covered by insurance and it is expensive.

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Current Treatments for Mesothelioma

All current treatments for mesothelioma that are considered the standard of care started out as clinical trials years ago.Example: Alimta and carboplatin are today

considered the standard-of-care treatment for malignant pleural mesothelioma. This chemo regimen was studied for many years in clinical trials and was approved by the FDA in 2004.

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What Exactly Is a Clinical Trial?

A controlled-research study under close medical supervision so people with mesothelioma can volunteer as a way to investigate new ways of detecting, screening, diagnosing and treating their disease.

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Purpose of Clinical Trials

Test new surgical techniques to remove tumors or control mesothelioma.

Determine better methods of disease surveillance. (Is an MRI or a PET scan better for tracking mesothelioma progression?)

Investigate new chemotherapy or biologic medications or agents.

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Clinical Trial Basics

Clinical trials are divided into phases. Most patients are involved in clinical trials which have progressed to phases III and IV.

Phase I: A very small group (20-50) of volunteers are given a brand new drug (or treatment) for the first time to evaluate safety and side effects. (Before phase I, these new drugs or treatments may have been tested on animals or in controlled lab environments.)

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Clinical Trial Basics (cont.)

Phase II: A slightly larger group of volunteers (100-300) are given a new treatment to determine dosing amounts and to test effectiveness and side effects at different doses.

Phase III: Large group of volunteers (1,000-3,000) are given the new treatment to confirm that it is effective. New treatment is usually compared to the current standard of care. Many phase III studies are carried out at different sites throughout the country.

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Clinical Trial Basics (cont.)

Phase IV: After FDA approval of the treatment, more studies can be carried out to confirm the treatment’s safety and determine if it can be combined with other medications or used to treat other diseases.

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Randomization and Control

All aspects of a clinical trial need to be controlled as much as possible to ensure that any differences observed between groups of volunteers are due only to the treatment. This is why there are strict criteria that patients need to meet in order to participate in a clinical trial.

Volunteers are selected randomly to different groups in the study to avoid any researcher or physician bias.

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Who Suggests a Clinical Trial?

Many oncology patients assume their physician will suggest that their patients consider participating in a clinical trial.New phases and locations of clinical trials are

opening all the time, and oncologists may not be able to keep up with those new developments.

Patients are encouraged to search for new clinical trials and ensure they tell their oncologist they are interested in clinical trials.

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How Do I Find Information About Mesothelioma Clinical Trials?

Before looking for clinical trials that you may be eligible for, it is important to gather your disease and treatment history details.

The National Cancer Institute recommends completing this checklist before searching for a clinical trial.ClinicalTrials.govCancer.gov/clinicaltrials/search

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Questions to Ask Yourselfand Your Physician

Is a clinical trial my only option at this point?

What phase is this clinical trial in?What will be my out-of-pocket costs?Will I need to travel far for treatment,

doctor appointments or lab work?

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Questions to Ask Yourselfand Your Physician (cont.)

What are the potential known risks of participating in the clinical trial?

What would be my treatment options if I were to choose or be forced to stop the clinical trial?

How long does the clinical trial last?Can I see the informed consent for the

trial?

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Making the Right Decision for You

There are many factors to consider in deciding if a clinical trial is right for you.

A patient should: Clarify your treatment goalsConsider how you define quality of life Determine how aggressively you want to pursue

disease controlConsider how much practical and emotional

support you have from loved ones

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Contact Information

1-877-626-5916

(877) 626-5916

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