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Monthly Archives: August 2019

Update on Clinical Trials: Summer 2019

Eleanor Ericson Mesothelioma NurseClinical Trials are where new drugs or treatments are evaluated, which is ultimately how progress is made in treating diseases. Theories are tested, and through the rigorous scientific process, evaluated. The findings must stand up to peer reviews and be duplicatable. Clinical Trials are done in stages and require rigorous adherence to the approved protocols.

Rare diseases, such as mesothelioma, have more difficulty getting the attention and interest of the scientific community than diseases that affect more people. A rare disease, by the definition of United States health organizations, is any disease affecting fewer than 200,000 people in the United States at any given time. Malignant mesothelioma, a disease with which only 2,500 to 3,000 people are diagnosed with annually, consequentially classifies as a rare disease. For reference, there are over 228,000 people diagnosed with lung cancer each year.

Rare diseases have some common characteristics. The symptoms are often similar to more common diseases. For example, with malignant mesothelioma, many relatively common symptoms can delay a correct diagnosis, leading to misdiagnosis and delayed treatment. Rare diseases also have issues with access to the best care and treatment, since there is such a small population of people with the disease and many medical centers are not equipped with expert researchers in that field.

In the summer of 2019, there are currently 88 clinical trials recruiting worldwide on for malignant mesothelioma. Of those, 57 are recruiting in the United States. Because of the small population of people with malignant mesothelioma, the trials are often offered at multiple locations in order to gain the largest share of trial participants. Texas has 23, followed by 20 in Maryland, 19 in California, 13 in Florida and New York, and 11 in Massachusetts

The clinical trials that are recruiting are varied in the approaches they are taking. Some of the therapies being studied include supplementing current therapies with immunotherapies. New drugs such as Olaparib (generic name: Lyporza) and other drugs known as PARP-inhibitors are also being studied for their treatment potential in mesothelioma. Other studies are collecting specimens and banking the tissue for study; there is a study trying to document the natural progression of the disease by collecting specimens from the same patient at various times; and, there are studies that are trying to improve the staging of the disease in order to pinpoint the best treatment for the various stages of malignant mesothelioma.

There are a number of opportunities for involvement in a clinical trial for people with mesothelioma. All clinical trials are voluntary and require your informed consent, which can be withdrawn at any point that you want. Consider joining, and ask your mesothelioma team if they know of any opportunities that would be right for you.

Mesothelioma Clinical Trial – July 2019

Lisa Hyde-Barrett, RN Mesothelioma Nurse

We encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known that nationally the statistics for participation in adult cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on

Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.

The official title to the Clinical Trial; Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma.

Purpose: The purpose of this study is to find out whether the combination of avelumab and Stereotactic Body Radiation Therapy- SBRT is safe and what effect avelumab has on mesothelioma when given in combination with SBRT. In addition, a goal of this protocol is to study the effect of radiation therapy on the immune system.  It is thought that radiation treatment may create a form of “vaccine” against cancer inside the body and immunotherapy may improve this effect. The combination of radiation treatment and immunotherapy may be more effective against cancer than either radiation or immunotherapy alone.

Sponsor: Memorial Sloan Kettering Cancer Center in collaboration with Pfizer.

Start Date: December 20, 2017

Completion Date: December 2020

Estimated Enrollment: 27 participants

How it Works: Treatment consists of one dose of avelumab every other week as well as a short course of SBRT after the first two doses of avelumab. The drug, avelumab is delivered by IV infusion. The SBRT is given after the first two doses of avelumab.


Inclusion:  Over age 18

      Be willing and able to provide written informed consent

Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma.

No plans for surgical resection

At least one prior line of systemic therapy. Patients on prior immunotherapy are eligible.

At least one targetable lesion appropriate for palliative SBRT and one non-target lesion.

Karnofsky Performance Score > 70%

If of childbearing potential, must be willing to use highly effective mode of contraception

For at least one month prior, during, and for 2 months after the end of active therapy

Adequate organ function demonstrated by lab tests- see  for parameters

If the patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.   


Currently participating and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.

Prior radiation therapy precluding SBRT

Continuous oxygen use

Current use of immunosuppressive medications- for exceptions see

Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.

Known prior severe hypersensitivity to investigational product or Ny component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies.

Patient who rapidly progressed on prior immunotherapy, as determined by the treating physician, are not eligible.

Prior Therapies:

  1. Treatment with a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered from adverse events due to agents administered.
  2. Prior chemotherapy, targeted small molecule therapy, within 4 weeks prior to study Day 1 or has not recovered from adverse events due to previously administered agent.
  3. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte- associated antigen-4 (CTLA-4) antibody (including ipiliumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within 4 weeks prior to study Day 1or has not recovered from adverse events.

Comorbidities or Prior Conditions

  1. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  2. Prior organ transplantation including allogenic stem-cell transplantation.
  3. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  4. Known history of active TB
  5. Known history of HIV or known acquired immunodeficiency syndrome.
  6. Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection at screening or positive serologies indicating prior infection.
  7. Active infection requiring systemic therapy.
  8. Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  9. Clinically significant cardiovascular disease, cerebro vascular accidents/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrythmia requiring medication.

Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective means of birth control.

Vaccinations within 4 weeks prior to the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines.

Concomitant use of the following medications

  1. Any investigational anticancer therapy
  2. Any concurrent chemotherapy, immunotherapy, or biologic therapy.  Concurrent use of hormones for non-cancer related conditions (e.g. Insulin for diabetes and hormone replacement therapy) is acceptable.
  3. Immunosuppressive medications including, but not limited to systemic corticosteroids, methotrexate, azathioprine, and tumor necrosis factor alpha blockers. Use of immunosuppressive medications for the management of investigational product-related AEs, in subjects with contrast allergies is acceptable. In addition, use of inhaled and intranasal corticosteroids is permitted.

Known contraindications to radiotherapy.

Contact: Andreas Rimner, MD 212-639-6025  
Contact: Marjorie Zauderer, MD 646-888-4656


Definitions from

With any clinical trial, all participation is voluntary.  Before enrollment a detailed consent form will be reviewed with the participant and signed.  The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.


A type of therapy that uses substances to stimulate or suppress the immune system to help the body fight cancer, infection, and other diseases. Some types of immunotherapy only target certain cells of the immune system. Others affect the immune system in a general way. Types of immunotherapy include cytokines, vaccines, bacillus Calmette-Guerin (BCG), and some monoclonal antibodies.

Stereotactic Body Radiation Therapy

A type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue.


A drug used with axitinib to treat advanced renal cell carcinoma (a type of kidney cancer) that has not already been treated. It is also used to treat urothelial carcinoma (a type of bladder cancer) that is locally advanced or has spread to other parts of the body. It is used in patients whose disease got worse during or after treatment with anticancer drugs that included platinum. Avelumab is also used to treat Merkel cell carcinoma (a rare type of skin cancer) that has spread to other parts of the body. It is also being studied in the treatment of other types of cancer. Avelumab binds to a protein called PD-L1, which is found on some cancer cells. Avelumab may block PD-L1 and help the immune system kill cancer cells. It is a type of monoclonal antibody and a type of immune checkpoint inhibitor. Also called Bavencio.

Immune system

A complex network of cells, tissues, organs, and the substances they make that helps the body fight infections and other diseases. The immune system includes white blood cells and organs and tissues of the lymph system, such as the thymus, spleen, tonsils, lymph nodes, lymph vessels, and bone marrow.


Lisa Hyde-Barrett, RN Mesothelioma NurseAs new innovations and treatments emerge, there is growing hope in the mesothelioma community. We have written about clinical trials, chemotherapy, surgical interventions, palliative care, radiation therapy and more, but behind all this research into different treatment modalities, there is a passion that drives us to work towards a cure. According to Webster’s Dictionary, the definition of passion is a “strong feeling of enthusiasm or excitement about something or about doing something.” Passion is exactly what we experienced at a conference last week in New York, surrounded by doctors, nurses, advocates and caregivers.

The International Association for the Study of Lung Cancer (IASLC) hosted a conference for the mesothelioma community to share their findings related to research into mesothelioma. Because mesothelioma is an international issue, there were experts and researchers from all over the world collaborating, sharing research, and debating on cutting-edge research and treatments for this disease. Throughout the conference, there was a common and shared passion to keep going forward, to learn from others’ experiences and stay informed on which treatments have worked and which do not.

As we convened in a conference area, many shared more private and personal stories of hope and success in fighting this illness. Shared stories have a way of bringing the mesothelioma patient’s experience to the people behind the scenes, who use the information for passion to continue and innovate in their research. Mesothelioma is a rare disease, and to have world-renowned experts collaborating and sharing is a testimony to the passion of the mesothelioma community.

Each month at our Mesothelioma Center, we meet many new patients, each with new stories about how this disease has affected them. Fortunately, we all have passion in treating this disease and not one of us – doctor, nurse, patient nor caregiver – has ever given up. We are a group of healthcare professionals who found ourselves caring for people who have a rare disease. While the challenges of treating mesothelioma are ever present, it is our passion that drives us to get to know each patient, stay connected and informed with the mesothelioma community, and dare to try new treatments in hope for the best.

When finding a mesothelioma center and a team to treat you, be sure to be mindful of the passion. It is a feeling of encouragement and energy that cannot be found anywhere else. Passion is not taught in medical or nursing school; it is found in a team of people who care and want to see patients have the best possible outcome. There are plenty of other places people could have chosen on a humid summer’s day in New York City, but the mesothelioma community chose to be at the IASLC conference and contribute their discoveries to the world. There was hope and passion from all, and this will help develop more treatments.

Malignant Pleural Mesothelioma Affects All Types of People

Lisa Hyde-Barrett, RN Mesothelioma NurseMesothelioma, as we know, is caused by exposure to asbestos, which has long been associated with blue-collar industries such as construction and maritime trades. Yet, as we continue treating patients, we meet many people with mesothelioma who do not fit in these categories. This week, we met with two patients, one of whom is a local teacher and the other a healthcare professional. Both of them are under 60 years of age, one a female and one a male. One of them was very physically active and was experiencing an uncommon shortness of breath; the other had a pain on their right side which was getting worse.

The teacher and healthcare professional come from very different areas of the United States, and are unsure of how they were exposure to asbestos. Both have different mesothelioma types and locations within their bodies. (Unfortunately, mesothelioma strikes important organ clusters. For example, mesothelioma cells can start growth in the lungs, the diaphragm, and the heart.)

No matter your sex, age, or ethnicity, many people have the diagnosis of mesothelioma in common. For everyone, it is important to seek out medical opinions. Each diagnosis came from their respective local hospitals, but fortunately, both ended up at a Mesothelioma Center, where advanced treatment options are available. Still in 2019, people are unaware of mesothelioma specialists and that there are treatments offered. Mesothelioma may be a rare disease, but there are so many support options. For example, there is assistance with travel to a Mesothelioma Center if needed, and often, there is help for lodging expenses available, too. At a Mesothelioma Center, each case is evaluated, and treatment options are recommended based on your disease stage, what treatments you are eligible for, and what you are comfortable with.

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