Hope When Standard Treatments Are Not Enough
You have been diagnosed with mesothelioma. You have learned about surgery, chemotherapy, and radiation. Those are the standard treatments. For many patients, they work well. But maybe you have been told that standard treatments are not working for you. Maybe your cancer has stopped responding to chemotherapy. Maybe you are not healthy enough for surgery. Maybe you are looking for something more.
You are not out of options.
There is a whole world of new treatments being developed right now. Immunotherapy drugs that help your own immune system fight cancer. Targeted therapies that attack cancer cells while leaving healthy cells alone. Gene therapies that change how cancer cells behave. New combinations of existing drugs that work better together.
These new treatments are not yet available to everyone. They are being tested in clinical trials. Clinical trials are research studies that test new treatments to see if they are safe and effective. For many mesothelioma patients, clinical trials offer hope when standard treatments have failed.
This guide will walk you through everything you need to know about mesothelioma clinical trials. You will learn what clinical trials are, what new treatments are being tested, how to find trials you might qualify for, how to decide if a trial is right for you, and how to get financial help to participate. No complicated medical language. No confusing research jargon. Just clear, honest information to help you find hope and options.
What Are Clinical Trials?
Let us start with the simple explanation.
Before a new treatment can be given to everyone, it must be tested. Scientists need to know if it works. They need to know if it is safe. They need to know what side effects it causes. They need to know how it compares to existing treatments.
The way they get this information is through clinical trials.
A clinical trial is a research study that involves human volunteers. The volunteers are people like you. People with mesothelioma who are willing to try a new treatment. By participating in a clinical trial, you help scientists learn whether the new treatment works. And you may benefit from the treatment yourself.
The Four Phases of Clinical Trials
Clinical trials happen in phases. Each phase has a different purpose.
Phase 1 Trials
This is the first time a new treatment is tested in people. The goal of a Phase 1 trial is to find out if the treatment is safe. Doctors start with very low doses. They slowly increase the dose to find the highest dose that is safe. They also look for side effects.
Phase 1 trials are small. They usually have only fifteen to thirty patients. The goal is not to see if the treatment works. The goal is to see if it is safe. But sometimes patients in Phase 1 trials do very well.
Who should consider a Phase 1 trial? Patients who have tried all standard treatments and they did not work. Or patients who are not healthy enough for standard treatments.
Phase 2 Trials
Once a treatment has been shown to be safe, it moves to a Phase 2 trial. The goal of a Phase 2 trial is to find out if the treatment works. Doctors give the treatment to a larger group of patients, usually fifty to one hundred people. They watch to see if the tumors shrink. They watch to see if patients live longer.
Phase 2 trials also continue to watch for side effects.
Who should consider a Phase 2 trial? Patients who have tried standard treatments without success. Or patients who want access to promising new treatments.
Phase 3 Trials
If a treatment looks promising in Phase 2 trials, it moves to a Phase 3 trial. The goal of a Phase 3 trial is to compare the new treatment to the current standard treatment.
Patients are randomly assigned to one of two groups. One group gets the new treatment. The other group gets the standard treatment. This is called a randomized trial. It is the best way to know if the new treatment is actually better than what is already available.
Phase 3 trials are large. They can include hundreds of patients from many different hospitals and cancer centers.
Who should consider a Phase 3 trial? Patients who want access to a new treatment that might be better than the standard treatment. Also patients who want to help advance medical science.
Phase 4 Trials
After a treatment has been approved by the FDA, it may be studied in a Phase 4 trial. These trials look at long-term safety and effectiveness. They follow patients for years to watch for rare side effects or late effects.
New Mesothelioma Treatments Being Tested Right Now
There are dozens of new mesothelioma treatments being tested in clinical trials right now. Here are some of the most promising.
Immunotherapy for Mesothelioma
Immunotherapy for mesothelioma is one of the most exciting areas of research. Immunotherapy drugs do not attack cancer directly. Instead, they help your own immune system recognize and attack cancer cells.
Two immunotherapy drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), have already been approved by the FDA for mesothelioma. But researchers are testing many more.
What is being tested now:
- New immunotherapy drugs that work in different ways
- Combinations of immunotherapy with chemotherapy
- Combinations of two or three immunotherapy drugs together
- Immunotherapy before surgery (neoadjuvant immunotherapy)
- Immunotherapy after surgery (adjuvant immunotherapy)
Promising trials: Several trials are testing immunotherapy drugs called pembrolizumab (Keytruda), durvalumab (Imfinzi), and atezolizumab (Tecentriq) for mesothelioma.
Targeted Therapy
Targeted therapies are drugs that attack specific molecules that cancer cells need to grow. Unlike chemotherapy, which kills all fast-growing cells (including healthy ones), targeted therapies are more precise. They attack cancer cells while leaving healthy cells alone.
Researchers have identified several targets in mesothelioma cells. Clinical trials are testing drugs that attack these targets.
What is being tested now:
- Drugs that target the mesothelin protein (found on most mesothelioma cells)
- Drugs that block blood vessel growth to tumors
- Drugs that interfere with cancer cell division
- Drugs that cause cancer cells to self-destruct
Gene Therapy
Gene therapy is a way to treat cancer by changing the genes inside cancer cells. The most common approach for mesothelioma is called suicide gene therapy.
Here is how it works. A harmless virus is modified to carry a special gene. The virus is injected into the chest or abdomen where the mesothelioma is. The virus infects the cancer cells and delivers the gene. Then the patient takes a medication that activates the gene. The activated gene kills the cancer cells from the inside.
Promising trials: Several trials have tested a gene therapy called aglatimagene besadenovec (trade name Oncorine). Results have been promising for patients with early-stage disease.
CAR T-Cell Therapy
CAR T-cell therapy is a type of immunotherapy where doctors remove some of your own immune cells, genetically modify them to recognize and attack cancer cells, and then put them back into your body.
This treatment has been very successful for some types of leukemia and lymphoma. Researchers are now testing it for mesothelioma.
Promising trials: Several trials are testing CAR T-cells that target the mesothelin protein. Early results show that the treatment is safe and can shrink tumors in some patients.
Tumor Treating Fields (TTFields)
Tumor Treating Fields use low-intensity electrical fields to disrupt cancer cell division. The electrical fields are delivered through electrodes placed on the skin.
This treatment has been approved for a type of brain cancer called glioblastoma. Researchers are testing it for mesothelioma.
Promising trials: A large clinical trial tested TTFields for mesothelioma. The results showed that patients who received TTFields plus chemotherapy lived longer than patients who received chemotherapy alone.
HIPEC Variations
HIPEC (Heated Intraperitoneal Chemotherapy) is already a standard treatment for peritoneal mesothelioma. But researchers are testing new variations.
What is being tested now:
- Different chemotherapy drugs for HIPEC
- Different temperatures for the heated chemotherapy
- HIPEC with immunotherapy drugs added
- Repeated HIPEC for patients who relapse
How to Find Mesothelioma Clinical Trials
Finding clinical trials can feel overwhelming. But there are resources to help.
ClinicalTrials.gov
ClinicalTrials.gov is the largest database of clinical trials in the world. It is run by the US government. It is free to use.
To search for mesothelioma trials:
- Go to ClinicalTrials.gov
- Type “mesothelioma” in the search box
- You will see a list of hundreds of trials
- You can filter by location, phase, and study status
The information on ClinicalTrials.gov is technical. It can be hard to understand. Ask your doctor or a patient navigator to help you.
The Mesothelioma Applied Research Foundation
The Mesothelioma Applied Research Foundation (curemeso.org) has a clinical trial finder. They also have patient navigators who can help you understand your options.
Cancer Centers
The top mesothelioma treatment centers all have clinical trials. When you call a center for a consultation, ask about their clinical trials. They will tell you what trials are open and whether you might qualify.
Your Doctor
Your local oncologist can also help you find clinical trials. Many community oncologists are connected to research networks. They can search for trials that might be right for you.
How to Decide If a Clinical Trial Is Right for You
Participating in a clinical trial is a big decision. There are potential benefits and potential risks. Here is what to consider.
Potential Benefits
- You may get access to a new treatment that is not available anywhere else
- The new treatment may work better than standard treatments
- You will receive close monitoring by a research team
- You will be helping future mesothelioma patients by advancing medical science
Potential Risks
- The new treatment may not work
- The new treatment may cause side effects that are not yet known
- You may be randomly assigned to the standard treatment group (in Phase 3 trials)
- The trial may require extra visits, extra tests, and travel
Questions to Ask Before Joining a Trial
Before you decide to join a clinical trial, ask these questions.
- What is the purpose of this trial?
- What treatments will I receive?
- Will I know which treatment I am getting?
- What are the possible side effects?
- How long will the trial last?
- Will I have to travel? Who pays for travel?
- Does the trial pay for my treatment? What does my insurance pay for?
- Can I leave the trial if I want to?
Does Insurance Cover Clinical Trials?
This is a common concern. The answer is. It depends.
What insurance usually covers: Your insurance will usually cover the routine costs of your cancer care. Doctor visits, hospital stays, scans, and lab tests. These are things that would be covered even if you were not in a trial.
What the trial usually covers: The trial sponsor (drug company, research institute, or government) usually pays for the experimental treatment itself. They also pay for any extra tests or visits that are required only for the research.
What you need to check: Before you join a trial, talk to the research coordinator. Ask for a written explanation of what the trial pays for and what your insurance pays for. Then call your insurance company and verify that they will cover the routine costs.
Travel and Lodging for Clinical Trials
Many clinical trials are only available at large cancer centers in major cities. If you do not live near one, you may need to travel.
Help is available:
- Some trials include travel and lodging allowances
- The American Cancer Society offers free lodging through their Hope Lodge program
- Mercy Medical Angels and other organizations offer free or discounted air travel
- Your lawyer may be able to help with travel expenses if you have a pending lawsuit or trust fund claim
Ask the clinical trial coordinator about help with travel and lodging.
Stories of Hope: Patients Who Benefited from Clinical Trials
Clinical trials are not just research. They are real people getting real treatment. Here are examples of how clinical trials have helped mesothelioma patients.
The immunotherapy success: A 62-year-old man with pleural mesothelioma had already tried chemotherapy. His cancer came back. He joined a clinical trial testing a combination of two immunotherapy drugs. Within three months, his tumors had shrunk by more than 50 percent. Two years later, he is still doing well.
The HIPEC survivor: A 55-year-old woman with peritoneal mesothelioma was told she had less than a year to live. She joined a clinical trial testing a new HIPEC protocol. She had surgery and heated chemotherapy. That was eight years ago. She is still cancer-free today.
The gene therapy patient: A 70-year-old man was not healthy enough for surgery. He joined a gene therapy trial. The treatment was injected into his chest. His tumors stopped growing. He lived two years longer than his doctors expected.
These are real stories. They could be your story too.
Frequently Asked Questions
Are clinical trials safe?
Clinical trials have many safeguards. Before a trial can start, it must be approved by an Institutional Review Board (IRB). The IRB includes doctors, researchers, and community members. Their job is to protect patient safety. You are also watched closely during the trial. You can leave at any time.
Will I get a placebo?
Very rarely. In cancer trials, it is considered unethical to give a placebo when a patient has a serious disease. If a trial has a control group, the control group usually gets the current standard treatment, not a placebo.
What if the treatment does not work?
That is always a possibility. But if the treatment does not work, you can leave the trial. You can then try other treatments, including other clinical trials.
Can I get a clinical trial if I have already had chemotherapy?
Yes. Many clinical trials are specifically for patients who have already tried standard treatments.
How long does a clinical trial last?
It depends on the trial. Some trials last a few months. Others last several years. Your trial coordinator will explain the timeline.
Will I have to pay to participate in a clinical trial?
No. You should never have to pay to participate in a clinical trial. The trial sponsor pays for the experimental treatment. You or your insurance may need to pay for routine care costs, but not for the experimental treatment itself.
How to Get Started
If you are interested in mesothelioma clinical trials, here is what to do.
Step One: Talk to your doctor. Tell them you are interested in clinical trials. Ask for their advice.
Step Two: Contact a top mesothelioma treatment center. Ask for a consultation. Ask about their clinical trials.
Step Three: Search ClinicalTrials.gov. Make a list of trials that might be right for you.
Step Four: Contact the trial coordinators. Ask your questions. Find out if you qualify.
Step Five: Get help. Patient navigators at the Mesothelioma Applied Research Foundation can help you understand your options.
Hope for the Future
A mesothelioma diagnosis is serious. But the future is brighter than it has ever been. New treatments are being developed at an amazing pace. Immunotherapy is helping some patients live for years. Gene therapy and targeted therapy are showing real promise. Clinical trials are offering hope to patients who had few options just a few years ago.
You do not have to face this alone. There are doctors, researchers, patient navigators, and other patients ready to help you. There are mesothelioma clinical trials that might be right for you.
Do not give up. Do not stop looking for options. Do not stop hoping.
Take the first step today. Talk to your doctor. Contact a mesothelioma specialist. Search for clinical trials. Your next treatment could be just around the corner.
Disclaimer: This article provides general information about mesothelioma clinical trials and emerging treatments. It does not constitute medical advice. Every patient’s situation is different. Always consult with qualified medical professionals about your specific treatment needs. If you or a loved one has been diagnosed with mesothelioma, speak with a doctor immediately and ask about clinical trial options.