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Interferon Alfa-2b Clinical Trials

Gene therapy is one of several areas of novel treatment under research for mesothelioma and other types of cancer. It is a strategy that involves manipulating genes to help destroy cancer cells. A major area of research for difficult cancers like mesothelioma involves inserting manipulated cells into the patient’s body in order to target cancer cells.

One particular type of gene therapy, involving a gene known as interferon alfa-2b, is being tested in a phase 3 clinical trial. The biotechnology company Trizell announced recently that it would be starting the next phase after successful results in phase 2. This kind of gene therapy has been used in other types of cancer patients, and now those with pleural mesothelioma may be able to benefit from it.

Interferons to Treat Disease

The use of interferons in disease treatment is not new, but it is novel to be using it to manage malignant mesothelioma. Interferons are proteins that play a role in signaling between cells in the body. They typically respond to viruses and have been used already in managing certain viral infections, including hepatitis.

When a healthy cell is being infected or attacked by a virus it releases interferons. These then travel to other nearby cells to send a warning. Those cells get ready to defend against viruses in response. Interferons also play a role in activating immune system cells and increasing the production of antigens. Some of the symptoms of having an infection, like fever or muscle aches, are the results of the actions of interferons.

How Interferon Alfa-2b Treats Cancer

Interferon Alfa-2b is a particular type of interferon protein that is already approved by the U.S. Food and Drug Administration (FDA) to treat certain viral infections and types of cancer. It is currently approved to treat hepatitis B and C and genital warts.

Cancers that this protein is approved to treat includes hairy cell leukemia, malignant melanoma after surgical treatment, Kaposi’s sarcoma caused by AIDS, and non-Hodgkin’s lymphoma with another type of medication. Although not approved for other uses, doctors may prescribe Interferon Alfa-2b injections for other viral infections, T-cell lymphoma, and kidney cancer.

Interferon alfa-2b is given to patients as an injection. The injection contains adenovirus cells that have been manipulated to contain the gene for the protein. When injected into the body, the adenovirus enters cells and breaks down but the gene stays intact. It is then translated into the protein interferon alfa-2b. The patient’s cells manufacture the protein, which then goes into action stimulating the immune system and helping the body’s natural defenses slow or stop tumor growth.

Phase III Clinical Trial for Malignant Mesothelioma

Trizell, a British biotech company recently announced it would be starting a phase 3 clinical trial for patients with malignant pleural mesothelioma. The trial is testing the effectiveness of its interferon alfa-2b drug, known as TR002.

This phase of the trial follows a fairly successful phase 2 trial of TR002. Conducted at the Abramson Cancer Center at the University of Pennsylvania, the phase 2 trial included 40 patients with pleural mesothelioma. The results were promising with an 87.5 percent control rate of the overall disease in participants. Survival time was nearly doubled in patients. About one quarter of participants lived two years and 20 percent lived three years. This is compared to a median survival rate of 18 months for pleural mesothelioma patients.

The phase 3 trial will require about 300 patients with pleural mesothelioma. It will be a randomized, parallel, open-label study. The participants will receive one dose of the adenovirus directly into the pleural cavity in the chest. They will then be given chemotherapy with gemcitabine two weeks later.

Recruiting for the Trial

If you think you may be eligible for the Trizell trial and want to participate, talk to your medical team. The trial is recruiting patients with pleural mesothelioma and only those who have already had first-line chemotherapy that failed. Recruitment is currently ongoing at multiple sites in the U.S. as well as in Europe, Russian, and Australia. There are likely to be other eligibility requirements you will need to meet, so talk to your specialists about finding out what they are and getting any necessary tests to prove you meet them.

Interferon and Peritoneal Mesothelioma

While the phase 3 trial is just for patients with pleural mesothelioma, there is a similar trial going on in phases 1 and 2 that involve peritoneal mesothelioma patients. The clinical trial involves a vaccine-delivered interferon along with other drugs and after surgery to remove tumors in the abdominal cavity. The study is using patients’ immune cells to create the vaccines and hope that the results will be an immune response that kills cancer cells.

Potential Adverse Events

As with any clinical trial and novel therapy there are risks. One is that the treatment simply may not work for you. It can be devastating to get your hopes up for an experimental therapy only to be disappointed. Keep this in mind when applying for clinical trials.

There are also specific risks of adverse events associated with interferon alfa-2b therapy. These include bleeding and bruising at the injection site, loss of taste, hair loss, dry mouth, dizziness, difficulty concentrating, changes in weight, and skin changes. Serious potential side effects include anaphylactic shock, a severe allergic reaction, stomach pain and swelling, extreme fatigue, diarrhea, nausea, vomiting, confusion, back pain, and loss of consciousness.

Interferon treatments and other types of gene therapy are very exciting for researchers and for patients living with mesothelioma. This is a difficult cancer to treat and most people have shortened life expectancies. The phase 3 trial with TR002 shows great promise and researchers hope to help more patients. If you want to get involved with this or another clinical trial, talk to your medical team and specialists about the risks, whether or not you qualify, and how to proceed.

Page Edited by Dave Foster

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Dave has been a mesothelioma Patient Advocate for over 10 years. He consistently attends all major national and international mesothelioma meetings. In doing so, he is able to stay on top of the latest treatments, clinical trials, and research results. He also personally meets with mesothelioma patients and their families and connects them with the best medical specialists and legal representatives available. Connect with Patient Advocate Dave Foster
Sources
  1. Trizell Ltd. Announces Phase 3 Pivotal Study of Interferon Alfa-2b Gene Therapy in Malignant Pleural Mesothelioma. (2019, March 20).
    Retrieved from: https://www.prnewswire.com/news-releases/trizell-ltd-announces-phase-3-pivotal-study-of-interferon-alfa-2b-gene-therapy-in-malignant-pleural-mesothelioma-300815572.html
  2. National Institutes of Health. National Cancer Institute. (n.d.). Dendritic Cell Vaccine, Recombinant Interferon Alfa, Rintatolimod, and Celecoxib After Surgery in Treating Patients with Peritoneal Surface Cancers.
    Retrieved from: https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2014-01357&r=1

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