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Clinical Trials for Mesothelioma

Mesothelioma is a deadly disease. Although it has been known for decades, it was largely ignored until the efforts of mesothelioma lawyers, doctors, and advocacy groups, fighting for the rights of mesothelioma victims, spurred research efforts to not only help ease patient’s pain and suffering but to try to find a cure. These efforts are still quite new. As a result, many treatment approaches and drug therapies are still being investigated through clinical trials.

What are clinical trials?

Clinical trials are medical studies designed to research and evaluate new drugs, surgical procedures and other treatments. Clinical studies are performed at various hospitals and institutions, clinics, and doctor’s offices. A study may be performed at one cancer center or at hundreds of locations around the country and overseas.

The National Cancer Institute (NCI) sponsors clinical trials as does the Department of Veteran’s Affairs (VA), the Department of Defense, and other federal agencies. Physicians, hospitals, foundations such as the Mesothelioma Applied Research Foundation, Inc. (MARF), voluntary groups, drug companies, and biotechnology companies also sponsor clinical trials.

One of the many ways the NCI sponsors clinical trials is through the Community Clinical Oncology Program. This program makes clinical trials available to many communities across the US. Local hospitals affiliate with cancer centers or cooperative groups which enables their doctors to offer patients the opportunity to participate in certain clinical trials without the need to travel far from home.

There are several types of clinical trials. These include:

  • Treatment trials which test experimental treatments, new drug combinations, new surgical approaches and new types of radiation therapy
  • Diagnostic trials to find new or better tests and procedures to diagnose illness
  • Screening trials which test ways to detect certain diseases or conditions
  • Supportive care trials investigate palliative treatments which explore ways to improve a patient’s quality of life as well as ways to alleviate treatment side effects
  • Prevention trials study ways to reduce the risk of developing disease and also study ways to prevent the recurrence of diseases such as cancer
  • Genetic studies are sometimes part of other clinical trials and focus on, for example, how a person’s genetic makeup affects the detection or diagnosis of or the response to cancer

Why are clinical trials important?

By participating in clinical trials, mesothelioma patients have the opportunity to obtain cutting-edge treatment that may not be available outside the investigational settings for years. You can play an active role in your treatment. You can also contribute to medical science.

When should I look into clinical trials?

Right away. Timing is important. Clinical trials eventually fill up, even for a rare disease like mesothelioma, so it’s important to look into what is available by talking to your medical team and searching online. Life expectancy for mesothelioma patients is short, so researching your treatment options as speedily as possible is crucial. Also, each clinical trial has specific eligibility requirements. These may exclude people who’ve had certain types of surgery or to other treatments so be sure to look at clinical trials while you’re investigating your treatment options.

What kinds of clinical trials are underway for mesothelioma?

More than 30 different clinical trials were underway for mesothelioma as of April 2006; several of these were being conducted at multiple sites across the country and around the world. These trials are underway to:

  • study ways to cure malignant mesothelioma
  • investigate palliative therapies-methods to address the pain and symptoms of mesothelioma without trying to cure the disease
  • research combination chemotherapy regimens for those who can be operated on as well as those with inoperable mesothelioma
  • investigate other ways to use traditional cancer treatments such as radiation and chemotherapy
  • test the effectiveness of therapies like combination cisplatin and Alimta®, which has been approved for inoperable malignant pleural mesothelioma, to see how this combination therapy works with surgery and radiation
  • test the effectiveness of Alimta® with other chemotherapy drugs
  • test experimental therapies such as gene therapy and photodynamic therapy
  • investigate methods to diagnose mesothelioma including discovering biomarkers to develop blood tests
  • test the effectiveness of different surgeries
  • test the effectiveness of surgery in combination with chemotherapy, radiation or other therapies

Safety

Most clinical studies in the US are federally regulated. Clinical trials must also be evaluated before and during the trial by the Investigative Review Board of the institution where they are being conducted to make sure the risks are as low as possible and worth the potential benefits. Clinical trials follow a protocol which details the trial. During the trial, researchers report results at scientific meetings, to medical journals and to government agencies. Although progress is reported, participant’s names are kept secret.

There are risks as well as benefits. Side effects could be unpleasant and even serious or life-threatening. Experimental treatments may not be effective and the study may require more doctor’s visits and tests than traditional treatments, since it’s so important to monitor your progress.

If you enroll in a clinical trial, you will be asked to sign an informed consent form which sets out details of the study such as the purpose of the trial, the length of time required, required tests and procedures, the risks and benefits, and important contacts. It’s your choice to enroll in a study. After you sign the consent, you may still withdraw from the study at any time. If new risks or side effects are discovered during the study, patients must be informed and may be asked to sign new informed consent forms.

Protocols

A protocol is the carefully prescribed action plan for a clinical trial. The protocol sets forth what the study will do, how it will do it, and why. It determines how many people will be in the trial, who is eligible to participate, what drugs, procedures or other treatments participants will be given, what tests they will receive, how often they will be tested, and what information will be gathered.

During a clinical trial, patients usually are examined by a doctor and tested more often than they would be were they receiving a traditional treatment. This is in order to closely monitor their progress, check for any side effects, and collect study data.

Doctors, nurses, dieticians, and social workers are all part of the clinical team.

What about my doctor?

Your primary physician is an important part of your medical team. Not only should you discuss the pros and cons of any clinical trial you’re contemplating with your doctor, but you will also continue to go to your doctor for care during the trial. Your primary physician should work with you and the rest of the research team to check your overall health and be sure any other medications you take don’t conflict with the protocol.

Phases

Clinical studies are broken down into four phases:

  • Phase I trials test experimental drugs or treatments in a small group of people for the first time after lab tests have shown promise, to test safety and determine a safe dosage range or the best way to administer a treatment. There may be a higher risk of side effects at this stage since less is known about the treatment.
  • Phase II trials give the experimental drug to or perform the experimental treatment on a larger group of people to see if it is effective and to further evaluate its safety. In this stage, investigators hope to learn, for example, whether the treatment being studied can shrink a particular tumor or otherwise benefit patients.
  • Phase III trials, usually the step before a drug is marketed or new procedure is approved, test the experimental study drug or treatment on a large group of people primarily to compare it to traditional treatments and to confirm its effectiveness, monitor side effects, and collect additional information for its safe use. In these trials, patients are randomly assigned (assigned by chance) to the experimental treatment or the traditional treatment to determine if the new treatment works as well or better. Neither the patient nor the doctor knows who’s been assigned to which treatment.
  • Phase IV trials are post-marketing studies which help obtain additional information about a drug’s risks, benefits, and best uses.

Finding clinical trials

Many leading cancer treatment centers and drug companies are conducting clinical trials in the hope of helping mesothelioma patients live longer. You might be eligible to participate in one so ask your doctor about different experimental treatments at the cancer center where you are being treated, or at others across the country.

You can also search for clinical trials across the county and around the world through the following web sites.

  • The National Cancer Institute site (1-800-4-CANCER) lets you find clinical trials offered anywhere from 20 to 500 miles from your home by simply putting in your zip code. Or leave the zip code parameter blank and search for trials anywhere. You can search by type of trial, such as treatment trials or supportive care. The advanced search function lets you narrow your search by drug, hospital, sponsor, phase and other variables. If you click on “NIH Clinical Center trial” under the “special” category, you can limit your search to those conducted at the NIH Clinical Center in Bethesda, Maryland or other special centers. There’s also a function which limits trials to those added in the last 30 days, so you can do a new search without repeating those you’ve looked at before. As of April 2006, a search for mesothelioma brought up 27 completely different trials, several of which were being conducted at multiple sites in the US and abroad.
  • The National Institutes of Heath (NIH) has a site devoted entirely to clinical trials. Click on “focused search” on the site and you can search by disease, type of treatment, location, age group, the phase of the study. You can even look for clinical trials specifically sponsored by the NIH, other federal agencies, industry, or universities and organizations. As of April 2006, a search using only the term “mesothelioma” brought up 32 unique studies, including several being performed at multiple sites across the country and abroad. There’s also a function which limits trials to those added in the last 30 days.
  • Thompson CenterWatch lists clinical trials, new drug therapies and recent FDA approvals. In April 2006, clicking on oncology and then narrowing the search to mesothelioma found 41 clinical trials. Some were testing the same treatment at different locations.
  • The Mesothelioma Applied Research Foundation (MARF) lists mesothelioma clinical trials on their site.

Once you find a trial on one of these web sites that seems like it might be beneficial, you should call the center where it’s being conducted to find out as much as you can about the risks, potential benefits, eligibility requirements, and costs and then discuss the suitability of the trial with your medical team and your family or close friends. If they have other questions you didn’t think of, call back and ask the center conducting the test.

The same clinical trial may be conducted at various locations so be sure to ask for all locations. You may find a location close to home, or close to the homes of relatives or friends with whom you can stay during treatment. It is certainly convenient to find clinical trials close to home, but remember there are organizations that can help you with travel expenses and a place to stay.

Costs

The cost of clinical trials can be tricky and it’s important to determine who pays for what.

There are two types of costs in clinical studies:

  • patient care costs
  • research costs

Patient care costs are generally those which you would have even if you were receiving traditional treatment, such as doctor visits, hospital stays, lab tests, x-rays, and the like. The patient is usually responsible for these costs and you need to determine whether your insurer will pay for them.

Often, the cost of investigational drugs and research costs, such as tests performed solely for research purposes, are covered by the sponsor of a clinical trial but you should always check which costs are covered by the sponsor and which are not.

Medicare reimburses certain patient care costs in clinical trials. See their website or call 1-800-MEDICARE (1-800-633-4227). In NCI-sponsored trials, TRICARE, the Department of Defense’s healthcare program covers certain patient care costs and the VA covers certain costs for eligible veterans. See the cancer.gov website for more information.

Some states now require coverage of patient care costs (not research costs) in certain clinical trials. Click here to see if your state has laws that may help.

The NCI sponsors clinical trials around the country. There is no charge for medical care at NCI-sponsored clinical trials at the NIH Clinical Center in Bethesda, Maryland but patients are responsible for travel costs for their initial screening visit. Usually, once a patient is enrolled in a trial there, the NCI covers transportation costs for all later visits for patients who do not live locally and these patients usually receive a small daily amount for food and lodging expenses if they are being treated as outpatients. You can search their site for more information.

Note: different websites have different information, so look everywhere and call to find out as much as you can about what’s available.

Eligibility requirements

Clinical trials require you to meet certain eligibility requirements such as being at a certain stage of the disease, or not having had radiation yet, or having had radiation once before – the requirements vary by the trial. Some clinical trials may require you to have a certain type of surgery during the study. Others may not let you participate if you’ve had certain surgeries or treatments. Many promising treatments for malignant mesothelioma are in the clinical study stage, so it’s a good idea to find out what treatment options are available through clinical trials as quickly as you can and discuss the risks and benefits with your medical team to determine what’s best in your particular case.

What if I’m not eligible for clinical trials?

Expanded access protocols sometimes make new drugs available to people who don’t qualify for other clinical trials. Drug manufacturers can sometimes make investigational drugs available to those with a life-threatening or serious illness who don’t meet the health, age or other requirements of a more carefully-controlled study. These protocols provide access to the drugs for additional patients and additional information about the drug’s safety for the company. These types of studies, which are sometimes available, can be found at www.clinicaltrials.gov by typing in the search term: “expanded access mesothelioma”. You can also use a regular search engine such as Google or Yahoo! and type in the words “expanded access” and the name of the drug you’re interested in to see if it’s available in expanded access trials, or contact the manufacturer.

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