Monday, November 5, 2007

Learning About Mesothelioma Clinical Trials

A clinical trial is a research study using volunteers. Its purpose is to find cures or treatments for diseases such as mesothelioma or other serious health conditions. Researchers must conduct animal or laboratory studies that produce positive results before they try a new procedure or drug on human subjects in a clinical trial. A typical mesothelioma clinical trial determines whether a treatment is safe and effective, the best way to administer a drug, and the proper dosage. Any side effects are observed and noted.

Some mesothelioma patients choose to participate in clinical trials in order to have a greater sense of control over their health, and renewed hope for an improved quality of life. Pemetrexed or Alimta® is an example of a drug originally tested in a mesothelioma clinical trial. It has been approved as a pleural mesothelioma treatment when combined with a standard chemotherapy agent, cisplatin.

The downside of clinical trials is that patients are participating in an experimental study. Results may be positive and helpful, inconclusive, or negative. There are no guarantees. You should carefully consult with your physician before you decide to participate in a mesothelioma clinical trial. Consider your own needs and desires, as well as your health status.

Types of Clinical Trials

Clinical trials are conducted in segments or phases. A phase I clinical trial determines how a drug works, and its side effects at various doses. It may give some preliminary evidence of effectiveness. Usually, only a small number of people take part in a phase I clinical trial. A phase II clinical trial involves more participants. Its purpose is to further evaluate the drug’s effectiveness, its safety, and side effects.

A phase III trial gathers even more information about the overall benefits and risks of a drug or treatment. For example, the effects of a new drug or procedure are compared to a current standard treatment. This is done by randomly assigning participants to receive the standard or new treatment. Phase III trials often enroll large numbers of people and may be conducted at several clinics or cancer centers at once.

Who Conducts Mesothelioma Clinical Trials?

The federal National Cancer Institute (NCI) of the National Institute of Health sponsors many of the clinical trials in the United States. The studies may be funded by the NCI and run by a network of doctors, hospitals, and cancer centers. Other sponsors include drug manufacturers, biotechnology companies, nonprofit groups, or even private physicians.

Finding Mesothelioma Clinical Trials

Your doctor or cancer center may recommend a particular mesothelioma clinical trial. You may also read about a clinical trial that is recruiting volunteers through a newspaper or magazine. Some patients actively look for clinical trials. If you are in the later category, you may want to consult the web sites listed below. They provide current lists of clinical trials, including eligibility requirements, geographic location, and medical background.

National Cancer Institute (NCI) Clinical Trial Search
This database may be accessed by type of treatment and geographical location. Also see the NCI’s advanced search, which allows you to locate clinical trials by drug or procedure name, your cancer stage, sponsor name, as well as by geographic area and other factors.
National Institute of Health Clinical Trial Search
You can indicate type of treatment or drug, stage of cancer, clinical study phase, or sponsor in accessing this database.
Coalition of National Cancer Cooperative Groups, Inc.
Provides a 9–step questionnaire before you may access the database. This may be somewhat burdensome.

In addition, you can check the web sites of major cancer centers near you. They usually have information about current mesothelioma clinical trials.
Questions to Ask About Mesothelioma Treatment and Clinical Trials

The American Cancer Society suggests asking these questions of your medical team before participating in a mesothelioma clinical trial.

* » Why is this study being done?
* » What is likely to happen in my case if I decide to participate or not participate?
* » What are my other options (standard treatments, other studies)?
* » What are their advantages and disadvantages?
* » What were the results in previous studies of this treatment?
* » What kinds of tests and treatments does the study involve? How often are they done, and how much time it required?
* » How could the study affect my daily life?
* » What are the possible side effects?
* » Will I have to be hospitalized? Will I still be seeing my regular doctor?
* » What are my costs, if any?
* » How long is the study?
* » Is long–term follow–up care part of the study?
* » Are there others participating in the study whom I could speak to?

Again, you will need to look at the risks versus the benefits of taking part in any clinical trial. Factors to consider include your own health, your expectations, your family relationships, and your present quality of life.


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