MESOTHELIOMA CLINICAL TRIALS
CLINICAL TRIAL BASICS
Clinical trials are studies of the safety and/or effectiveness of new drugs being tested on humans. For mesothelioma, trials are being conducted to find a better and more effective means of treatment. Anyone interested in participating in a clinical trial should discuss the particular trial thoroughly with their doctor before a making a decision on whether it is right for them.
All clinical trials carry potential benefits and risks, and it is important that you have a complete understanding of what you might expect. For instance, since clinical trials are often conducted at larger cancer centers, in many cases, travel may be necessary to receive treatment and routine tests. On the other hand, care is provided at top-notch facilities by physicians who are leaders in the field of cancer research. Another benefit would be having access to the new drug before it is widely available, however, the new drug may ultimately be proven not as effective as the “standard” of care.
Eligibility requirements for clinical trials are not the same; each study has specific guidelines to participate. Some trials allow participation after other treatments have failed, while others require that the patient have no prior treatment. Your doctor should be able to advise you which trial might be the best fit in your particular case.
Some treatment trials are “randomized”, meaning the new treatment is compared with a current standard of treatment. Depending on which arm of the protocol you are assigned, you may receive the new treatment or the standard. You should be informed in advance of this eventuality by the doctor conducting the trial. Placebos (pills that contain no active ingredient) are rarely used in cancer trials.
Though mesothelioma has no cure, there are clinical trials currently underway to test new drugs and procedures in the fight against the disease. All clinical trials or studies are divided into different phases:
Phase I trials usually enroll only a small number of people and test how new drugs or procedures should be administered.
Phase II trials give early information about whether or not a new drug or procedure works and also provide information about safety and benefit.
Phase III trials compare promising new drugs or procedures with the current standard treatment. Large numbers of people from across the nation usually participate in Phase III trials and receive either the new treatment or the standard treatment.
In order to be sure the study results are accurate, trial participants in all phases must fit a certain profile. Eligibility for mesothelioma trials are often specific as to age, how long it has been since therapy, stage of disease, and other characteristics. To find out about the eligibility requirements and other information for the trials listed below, click on the clinical trial web site listed after each trial or call one of our MW Coordinators toll-free at 1-877-FOR-MESO (367-6376).
CLINICAL TRIALS AND MEDICARE
If you choose to enter a clinical trial and are on Medicare, it is important that you have a complete understanding of the trial itself, and what costs will or will not be covered under your Medicare policy.
Clinical trials for cancer are currently covered if:
- The trial is funded by the National Cancer Institute (NCI), the NCI-Designated Cancer Centers, the NCI-Sponsored Clinical Trials Cooperative Groups or other Federal agencies that fund cancer research.
- The goal of the trial is to diagnose or treat cancer (cancer prevention trials are not covered).
Costs covered under Medicare for clinical trial participants include:
- Doctor’s office visits.
- Routine tests and/or procedures associated with a clinical trial.
- Services associated with the administration of investigational drugs during a clinical trial.
- Health care associated with a clinical trial, i.e., hospitalization for side effects.
Costs not covered under Medicare for clinical trial participants include:
- Investigational drugs being tested in a clinical trial.
- Services used only for the collection of data for a clinical trial.
- Anything provided to a trial participant at no cost by the sponsor of a clinical trial.
- Any coinsurance and/or deductibles.
If you are not sure whether the clinical trial you have chosen meets all necessary requirements, discuss your participation with your doctor, or contact the Medicare benefits office at 1-800-MEDICARE (1-800-633-4227).
CURRENT CLINICAL TRIALS
The National Cancer Institute states that the purpose of most listed clinical trials is to test new cancer treatments or new methods of diagnosing, screening for or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in each clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
The National Cancer Institute has a web page on clinical trials. Look there for current trials. http://www.cancer.gov/about-cancer/treatment/clinical-trials
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