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Mesothelioma clinical trials are carefully monitored research procedures which investigate whether a specific medical treatment is effective and safe. These clinical trials play a vital role the progression of cancer research necessary to develop treatment breakthroughs.

Mesothelioma Clinical Trials
Defining Mesothelioma Clinical Trials

What are Mesothelioma Clinical Trials?

Mesothelioma clinical trials are carefully monitored research procedures which investigate whether a specific medical treatment is effective and safe. These clinical trials play a vital role the progression of cancer research necessary to develop treatment breakthroughs. Participation provides patients with the opportunity to gain access to leading edge treatments. Clinical trials make treatment advancements possible. They fuel hope for the future. Clinical trial participation ovides access to the very best carefully monitored treatment. Participation provides valuable feedback and data which will help patients in the future.

Mesothelioma Clinical Trial Facts:

  • Currently, there are a multitude of clinical trials recruiting mesothelioma patients.
  • Clinical trials provide a highly structured, safe way to test experimental treatments.
  • Often, mesothelioma trials are testing medications currently approved for other cancers.
  • Each clinical trial has unique criteria which dictates who is eligible to enroll.
Mesothelioma Clinical Trials

What is a Clinical Trial?

Clinical trials are scientific research that involves people.   Trials are conducted in a very structured manner to determine if a new therapy approach is safe, effective and produces better results than current therapies.  Scientists use clinical trials to provide the proof necessary to show a new therapy will help individuals live longer better lives.

Every trial must comply with industry guidelines and strict regulations.  Guidelines and regulations help to guarantee high quality research data and patient safety.  Trials are funded by pharmaceutical companies, cancer centers, government agencies, or a combined partnership of several organizations.

Prior to a new drug being approved by the FDA, it often must go through multiple phases of trials.  Depending on the specific goals, the number of participants and the results of the trial, it can last anywhere from weeks, to months or even years.

Clinical Trial
Mesothelioma Clinical Trials

Why is Participation Signiant?

Currently, mesothelioma has no cure.  New treatments are being studied by doctors with hope that these therapies will enhance quality of life and extend survival rates.

Clinical trials can bring about a variety of potential outcomes.  Trials may show a gradual improvement in patient outcome.  Trials may produce a negative outcome which leads doctors to focus on a different theory.  A trial can lead to a major discovery that alters the methodology of cancer treatment.

For example, one of the decades greatest shifts in cancer treatment is due to the success of immunotherapy clinical trials.  The FDA (The U.S. Food and Drug Administration) has yet to authorize immunotherapy for mesothelioma patients.  However, many of the newest immunotherapy drugs are available to mesothelioma patients through clinical trials.

Mesothelioma Clinical Trials

What are the Best Mesothelioma Clinical Trials?

All clinical trials are vital in helping doctors identify new ways to treat mesothelioma.

A data base containing all the past and current clinical trials is maintained by NIH (The National Institutes of Health). Clinicaltrials.gov provides a comprehensive list of clinical trials.

Mesothelioma specialists can provide guidance and aid individuals in accessing new treatments.  Doctors can help identify if a clinical trial could be a beneficial match.

Each clinical trial has its own specific criteria which guides the eligibility of participants. While some trials only accept patients, who did not react favorably to conventional treatment other trials are only for patients who have never received treatment.

Mesothelioma Biopsy factors;

  • Past treatment history
  • Stage and type of mesothelioma
  • Patients general health
  • Patients gender and age
  • Underlying medical conditions
Mesothelioma Clinical Trials

Actively Recruiting Mesothelioma Clinical Trials

Mesothelioma is a rare form of cancer.  Annual mesothelioma diagnosis in the United States ranges from only 2,000-3,000 cases.  As a result, there is a great need for patients to participate in clinical trials.  Many trials are enrolling mesothelioma patients.  The following are a few of the most prominent.

Keytruda and CRS-207

In 2017, six different cancer centers started to enlist patients for a phase II clinical trial.  This trial involves combining two immunotherapy drugs:  Pembrolizumab and CRS-207.  In previous individual trials both have demonstrated favorable results.

Pembrolizumab, advertised as Keytruda, is a popular immunotherapy agent.  Keytruda has already been approved by the FDA for the treatment of several cancer types.  CRS-207 uses a genetically developed Listeria bacteria to produce an immune response.

Patients must have already received chemotherapy to qualify for this trial.  This trial is expected to continue through 2019.

Nivolumab and Ipilimumab

Following an encouraging 2016 clinical trial in France, 17 cancer centers worldwide are currently heading a phase III clinical trial.  The trial is evaluating whether a combination of immunotherapy drugs achieves better results than conventional chemotherapy for inoperable pleural mesothelioma.

As second- and third-line therapy options, these drugs nivolumab (Oppdivo) and ipilimumab (Yervoy), have already impressed researchers.  Patients in this study will have the opportunity to receive this immunotherapy treatment as a first-line therapy.

This trial is projected to last until 2021.  Patients are encouraged to join this trial if they are inoperable and newly diagnosed.

Mesothelioma Clinical Trials

Actively Recruiting Mesothelioma Clinical Trials

Durvalumab

A dozen cancer centers across the country, in 2017, started participating in a phase II clinical trial.  Dunvalumab is a promising immunotherapy drug used in this trial.  The FDA has already approved this drug for the treatment of bladder cancer.  It is noted for its effectiveness in lung cancer clinical trials.

Durvalumab triggers an immune system response targeting tumor cells.  It targets cells that overexpress the PD-L1 protein.  The PD-L1 protein is common in several cancers.

This is the first-time researchers are analyzing a combination of durvalumab and conventional chemotherapy as a first line therapy for inoperable mesothelioma.  To qualify, patients cannot have gotten any other form of therapy.

Anetumab Ravtansine

After encouraging clinical trial results in 2016, a number of cancer centers are currently assessing the immunotherapy drug anetumab ravtansine.  This is being tested as part of a first-line therapy regimen.

Anetumab ravtansine targets mesothelin.  Mesothelin is a tumor surface protein identified in 85-90 percent of mesothelioma cancer patients.  The new phase I trial will combine anetumab ravtansine with the two most common chemotherapy drugs used for mesothelioma, cisplatin and pemetrexed.

This is expected to be a yearlong trial.

Mesothelioma Clinical Trials

What Risks are Involved?

There are always certain risks in clinical trials, and the anticipated effectiveness of such experimental treatments may not be as expected. Unforeseen side effects that can harm your health may occur.

The FDA arranged clinical trials in four phases in order to make the process as safe as possible for patients.

Phase I

The trials of phase I involves the smallest number of selected participants of the four phases – typically ranging to about a dozen participants. The primary focus of such experimental therapies circulates safety – including analyzing side-effects, determining safe dosage levels and examining how the body processes the drug and/or procedure.

Phase II

The trials of phase II generally involve up to a few hundred participants. Such therapies circulate the effectiveness of new treatments while still regulating the safety levels.

Phase III

The trials of phase III account for the largest number of patients, including thousands of participants. Rather than the approach of standard treatments, these trials measure the effectiveness and efficiency of newer treatments. The quantity of dosages, as well as documented side effects are finalized generally finalized in phase III.

Phase IV

Drug developers can begin the marketing application of an approved drug following approval of the initial first three phases. Along with the first three phases, the FDA also has to provide approval. This may require additional trials within phase IV. Nonetheless, this phase confirms efficiency for specific indications after approval for commercial use.

Mesothelioma Clinical Trials

Can Patients Receive a Placebo?

The usage of placebos throughout cancer clinical trials is unlikely. Although not every participant partaking in clinical trials receive the new treatments being tested, each participating cancer patient receive excellent medical care. By participating in a clinical trial, patients will not miss high-quality medical care.

Participants are divided and placed into either a control group or a test group by medical examiners. Unlike the test group, the control group does not receive the experimental treatment(s).

The control group may receive a fake version of the treatment, called a placebo, in a clinical trial involving healthy patients. However, the control group will receive the appropriate standard cancer treatment in a cancer patient trial.

Researchers can never deliberately withhold the medical care patients may need.

Can Patients Receive a Placebo?
Mesothelioma Clinical Trials

Who Pays for Clinical Trials?

Patients cover expenditure on standard care. Typically, government agencies or pharmaceutical companies absorb most of the experimental drug costs.

Government and Industry Funding

With millions of dollars earmarked for clinical cancer treatment studies, the NCI’s 2017 budget was approximately $ 5.3 billion. Private sector financing has begun to dwarf direct government investment in recent years. It also plays an important role in hospitals, universities and other research organizations.

There were 80 clinical trials relating to mesothelioma were listed in the NIH database in the summer of 2017 – each of which can be divided into four categories based on the website’s funding source.

Funding Sources Number of Clinical Trials
U.S. Department of Defense 1
U.S. Institute of National Health 14
Biomedical and pharmaceutical companies 30
Cancer Centers, Universities, etc. 34

The cost of clinical trials can also be covered with assistance from private donations. The University of Hawaii Cancer Center, for example, had an anonymous mesothelioma research donor who donated $3.58 million in 2011.

Patient Costs

The costs for participants in clinical trials can also include hospital stays, laboratory tests, transport, scans, visits to doctors, and X-rays.

Depending on the patient’s policy, many of these costs are often covered by health insurance. In certain states health insurance companies are required (by special agreement or law) to pay for the routine care received in a clinical trial. The routine costs associated with all phase II and phase III clinical trials which are sponsored by the government are covered by Medicare for patients over the age of 65.

It is extremely important to talk to the clinical trial sponsor about the costs they will cover. To determine what they will cover, consult your health insurance company.

Factors that determine whether insurance companies pay for the costs of clinical trials include:

  • The potential risks that are involved with the trial
  • The phase of the trial
  • The duration of the study

Patients have faced numerous obstacles regarding cost – including with transportation. Some patients have had to travel to out-of-state cancer centers which require room and board arrangements. To aid these expenses, many charitable organizations and cancer centers offer grants to patients.

Questions to Ask Your Doctor
Mesothelioma Clinical Trials

Questions to Ask Your Doctor

It is very important for a mesothelioma patient must fully understand the details and purpose of the trial before registration. Any concerns which entail treatments opportunities, clinical centers, costs, side-effects, and so on should be brought up to trial sponsors.