About Mesothelioma Clinical Trials
Mesothelioma clinical trials offer groundbreaking research that is still in a testing phase. They can include tests for cancer treatment, prevention, screening, diagnosing and support.
Written by Jenna Campagna, RN
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Basic Information About Clinical Trials for Mesothelioma
Mesothelioma clinical trials are medical studies used to experiment with new treatment approaches for this disease. Clinical trials give hope, especially to people diagnosed with mesothelioma. Doctors and researchers use mesothelioma clinical trials to investigate, and hopefully prove, the effectiveness and safety of treatment methods.
The end goal of these studies is to receive approval from the United States Food and Drug Administration (FDA) to make a specific treatment a standard of care for this cancer. These treatment investigations can include:
- Specific drugs
- Combinations of different therapies
- Quality-of-life and mental health evaluations
- Support methods
- Diagnostic tests to better identify the presence of mesothelioma
One of the benefits of mesothelioma specialists and cancer centers is their ability to connect patients with clinical trials. Most, if not all, mesothelioma treatments and diagnostic procedures in use today have gone through clinical testing to ensure quality and safety.
The testing process, from concept to FDA approval, is lengthy. Medical breakthroughs for mesothelioma may exist, but they are not yet formally approved.
Benefits of Clinical Trials
If you have mesothelioma, then enrolling in a clinical trial can provide you an opportunity to receive new experimental treatments. Most participants of mesothelioma clinical trials have already been used to approve standard mesothelioma treatment options and are seeking additional therapeutic options. Strict regulations and procedures control these trials to ensure patient safety.
New treatments come in the form of radiation, chemotherapy, experimental drugs such as immunotherapy or virotherapy, or multimodal therapy that utilizes surgery. One, or some combination, of these treatments could be the cure for mesothelioma.
Health insurance often covers the medical care that’s part of clinical trials. Speaking with a specialist who is familiar with the trial’s sponsor or host company may help determine whether your insurance is accepted.
You can learn more about clinical trials in our free Mesothelioma Guide.
FREE MESOTHELIOMA GUIDE
Mesothelioma Packet Includes:
- 200+ Pages about your diagnosis
- 3 Books to improve your prognosis
- Wristbands to show your support
Clinical Trial Process
There are at least three phases of testing that a treatment must go through before the FDA considers approving it. A fourth phase may be needed for further testing and research.
Phase 1 is a test on a small group of people to determine:
- Whether the drug is safe to use
- How much of the drug the body can tolerate
- Potential side effects
- The most effective dosage
- How to administer the treatment (pill, liquid, intravenous or suppository)
According to the FDA, phase 1 trials typically last several months and include a smaller number of participants than the other phases. This phase is integral for designing tests in future phases of the clinical trial.
Phase 2 aims to determine the effectiveness of a treatment option. It ascertains how that treatment affects the area where the mesothelioma exists. The researchers examine whether there is disease response — either the cancer has regressed or stagnated in growth — and whether the same results can be reproduced in different patients.
According to the FDA, phase 2 trials can take up to two years to complete.
Phase 3 is often the final phase of clinical testing, and the results from this phase could lead to the FDA approving the treatment. Phase 3 tests whether the experimental treatment has better benefits than standard therapies. The benefits must include both disease response and safety.
Participants are often randomized into separate groups. One group will receive the experimental treatment, while the rest will act as a control group. Researchers use this setup to compare the effects of the treatment to what patients currently have available to them.
According to the FDA, phase 3 trials can take up to four years to complete. Few mesothelioma studies reach phase 3 status.
After the FDA approves a treatment, the agency may continue clinical testing. This step is called Post-Market Safety Monitoring, and it’s used to ensure that treatments are safe for widespread use. There is no timeframe for completing phase 4 trials.
Clinical Trial Success Story
Kendra Ferreira was diagnosed with peritoneal mesothelioma in 2001. Afterward, she began looking for additional treatment options. She faced a lack of available treatments for patients like her. Kendra found a mesothelioma specialist and participated in a clinical trial surgery, followed by chemotherapy. Nearly 20 years later, Kendra is a mesothelioma survivor.
“I was fortunate to be accepted into a clinical trial and I believe it saved my life,” she said.
You could be the next mesothelioma survivor providing hope to patients. Read more stories of survival in our free Mesothelioma Survivors Guide book.
Enrolling in a Clinical Trial for Mesothelioma
Inclusion in a mesothelioma clinical trial is entirely up to the patient and involves informed consent. Patients receive complete information regarding the clinical trial from their doctor. They’ll then sign a waiver agreeing to participate in the study. If at any time the patient would like to leave the trial, they are free to do so.
Each clinical trial is unique, with its own set of rules and standards that determine whether a patient is included (accepted) or excluded (denied). Patients are individually evaluated using test-related specifications, including:
- Age: Certain trials may test a treatment on a specific age group (example: 45-55). This disqualifies anyone older or younger than the specified age range.
- Gender: Certain studies may only apply to women (example: dual treatments on ovarian cancer and peritoneal mesothelioma). Other trials may use male hormones that would exclude women.
- Current health: The current or past health of a patient may determine whether certain trials accept them. Some trials won’t accept patients with particular medical histories.
- Mesothelioma type and stage: Certain trials focus on a specific mesothelioma type or stage (example: stage 2 pleural mesothelioma).
- Past treatment: Some studies exclude patients — or look to enroll patients — who have already undergone a specific treatment (example: surgery, chemotherapy or radiation). Studies may exclude patients who have already participated in a similar study (example: a previous immunotherapy study).
- Candidacy for future surgery: Many studies may exclude or enroll patients based on whether they are candidates for surgery.
Patients are accepted or denied based on these qualifications. There are many ongoing clinical trials for mesothelioma. If a patient is rejected from one trial, they should still apply to others.
A Word About Placebo-Controlled Mesothelioma Clinical Trials
Some people hesitate to enroll in clinical trials due to use of control groups and placebo-controlled trials. Understanding your options and how these studies help may alleviate concerns.
The words used to describe clinical trials can also create confusion. Terms such as “randomized,” “double-blind” and “placebo-controlled” refer to how a mesothelioma clinical trial is conducted and measured.
- What “placebo-controlled” means: Half the participants in this trial are given the drug being tested, while the other half are given a “placebo.” The placebo is a pill that looks identical to the actual drug but doesn’t contain any medicine. Those who get the placebo are chosen randomly, making the study “randomized.” A “double-blind” trial means neither the doctors nor the participants know who got a placebo.
- Why placebos are used: Researchers can get faster results by using placebo-controlled studies. Placebos provide a comparison, which helps researchers determine if the experimental drug is effective.
- Why trials are randomized and double-blind: Placebo-controlled trials are randomized and double-blind to prevent bias in the study results. These methods also give each participant a fair chance of receiving the non-placebo drug.
- If the patient’s condition worsens: Participants in any clinical trial are closely monitored by some of the best specialists in the country. If a patient’s condition worsens, the doctor will discuss the circumstances. Participants always have the option to drop out of a trial.
Deciding whether to participate in a placebo-controlled trial comes down to weighing your options. If you already had treatment, and this is the only potential maintenance treatment for you, then it is usually worth a shot. Contact one of our patient advocates to learn about clinical trials and expand your treatment options.
Sources & Author
- What Are the Phases of Clinical Trials? American Cancer Society. Retrieved from:
https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html. Accessed: 06/02/2020.
- Step 3: Clinical Research. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Accessed: 06/02/2020.