Posts Tagged ‘Clinical’

Comprehensive Screening and Clinical Assessment for Asbestos-Related Disease

Comprehensive Screening and Clinical Assessment for Asbestos-Related Disease

Examining Mesothelioma disease by juxtaposing various research studies leads to interesting conclusions.  One interesting study is called, “A histochemical study of the asbestos body coating” by M. Governa, C. Rosanda – Br J Ind Med 1972;29:  Here is an excerpt: “Abstract – A histochemical study of the asbestos body coating. Asbestos bodies after iron extraction were tested by histochemical methods for mucopolysaccharides. The results of the reactions suggest that acid mucopolysaccharides are present in the coating of most bodies. During the formation of the bodies acid mucopolysaccharides might act as a matrix for iron deposition on the coating.”

Another interesting study is called, “Medical examination for asbestos-related disease” by Stephen M. Levin MD, P. Elizabeth Kann MD, MPH, Michael B. Lax MD, MPH
Am. J. Ind. Med. 37:6–22, 2000.  Here is an excerpt: “Abstract – There are millions of workers whose exposure to asbestos dust prior to the implementation of asbestos regulation and improved control measures places them at risk of asbestos-related disease today. In addition, workers are still being exposed to significant amounts of asbestos, when asbestos materials in place are disturbed during renovation, repair, or demolition. Given the continued presence of asbestos-containing materials in industrial, commercial, and residential settings throughout the U.S., a sizeable population remains at risk of asbestos-related disease.

This article reviews the health effects associated with exposure to asbestos and delineates the steps necessary for the comprehensive screening and clinical assessment for asbestos-related disease, in order to assist physicians in identifying and preventing illness associated with exposure to asbestos among their patients.”

Another study is called, “Manganese superoxide dismutase genotypes and asbestos-associated pulmonary disorders” by Ari Hirvonena, Jarno Tuimalaa, Tiina Ollikainena, Kaija Linnainmaaa, Vuokko Kinnulab – Volume 178, Issue 1, Pages 71-74 (8 April 2002).  Here is an excerpt: “Abstract – Manganese superoxide dismutase (MnSOD) activity is highly elevated in the biopsies of human asbestos-associated malignant mesothelioma. We therefore examined if polymorphism in the mitochondrial targeting sequence of the MnSOD gene modified individual susceptibility to this malignancy or related asbestos-associated pulmonary disorders. The study population consisted of 124 male Finnish asbestos insulators who were all classified as having been exposed to high levels of asbestos; 63 of the workers had no pulmonary disorders and 61 either had malignant mesothelioma or the non-malignant pulmonary disorders asbestosis and/or pleural plaques. No significant associations were found between the MnSOD genotypes and these ill-health. This study therefore suggest no major modifying role for the MnSOD polymorphism in development of asbestos-associated pulmonary disorders.”

Another interesting study is called, “Cigarette Smoking, Asbestos Exposure, and Malignant Mesothelioma” by Joshua E. Muscat, and Ernst L. Wynder – Cancer Res May 1, 1991 51; 2263.  Here is an excerpt: “Abstract – In a hospital-based case-control study of 124 (105 male and 19 female) histologically confirmed malignant mesothelioma cases and age- and sex-matched controls, the role of cigarette smoking and the risk of asbestos exposure was investigated. Exposure to asbestos for at least 1 year was likely for 78% of male cases and 16% of female cases, and 90% of males were possibly exposed. Male cases worked predominately in the ship-building industry, construction, or insulation trades. Elevated risks were found for males employed in asbestos-related industries [odds ratio (OR) 8.1; 95% confidence interval (CI) 4.9–13.5], e.g., shipyards (OR 82.9, 95% CI 25.5–269.1), construction/maintenance (OR 8.3, 95% CI 4.6–14.8), and other asbestos-related jobs (OR 3.2, 95% CI 1.4–7.2), and for males who self-reported exposure to asbestos or insulation (OR 50.9, 95% CI 21.7–119.8). A statistically significant trend was found for the risk of mesothelioma with increasing years employed in non-shipyard asbestos-related occupations. Among women, only one case worked in an asbestos-related industry and two reported domestic contact with asbestos. No association between cigarette smoking and mesothelioma was found for either men or women. We also report the occurrence of mesothelioma in occupations which have not been previously reported.”

We all owe a debt of gratitude to these fine researchers for their important work.  If you found any of these excerpts helpful, please read the studies in their entirety.

Monty Wrobleski is the author of this article, for more information please click on the following links

Depuy Hip Recall Attorneys

Depuy Hip Recall Lawyers

Mesothelioma Lawyer


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Mesothelioma Clinical Trials ? A Good Option?

Mesothelioma Clinical Trials ? A Good Option?

Mesothelioma is an insidious form of cancer because of the fact it is often discovered so late that treatment options are simply non-existent. For many people, the only option is to consider clinical trials. The question is whether this is a good option.

What are clinical trials? They are testing periods for new drugs or procedures that may eventually prove effective and be approved by the FDA as a treatment for something. Put another way, they are the process of testing whether a drug or procedure does what it is intended to do. Sometimes they do. Sometimes they don’t.

Mesothelioma is a brutally difficult cancer to deal with for a unique reason. The problematic characteristic is it is very hard to find until it is too late for the patient. A person can have the cancer for 10, 20 or 30 years during which it can be treated, but still die of it because it went undetected. Given this problem, there are many different clinical trials going on all the time devoted to Mesothelioma treatments. For example, one related to the Mesomark, which is a promising new blood test that can lead to early detection.

Is it safe to take part in clinical trials? Generally, the answer is that it is safe to do so. A drug company does not just produce a drug and then start testing it on people. It must undergo testing and vetting processes before that happens. Still, clinical trials are undisputedly a form of experiment. The researchers think the drug or procedure being tested will work, but aren’t sure. This is, after all, why they have not been approved as of yet. The downside is usually just ineffectiveness, but side effects and rarely even death can occur.

Should you submit to clinical trials if you have Mesothelioma? The decision is entirely up to you. A late stage diagnosis of Mesothelioma is very often fatal, so there may be little choice.

Thomas Ajava is with MesotheliomaandAsbestosInformation.com – your online resource for Mesothelioma and asbestos information.


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What Are the Different Stages of a Mesothelioma Clinical Trial?

What Are the Different Stages of a Mesothelioma Clinical Trial?

Clinical trials are typically conducted in different phases. Each phase is designed to answer certain questions. Knowing the phase of the clinical trial is important because it can give you some idea about how much is known about the treatment being studied. There are advantages and disadvantages of taking part in each of the different phases of a clinical trial.

Clinical trials for mesothelioma cancer passes through this different stages:

1-Phase 0 clinical trials: Does the new drug work? How does it work?

Phase 0 studies are exploratory studies that involves the use of few small doses of a new drug in each patient. They test to find out whether the drug reaches the tumor, how the drug acts in the human body, and how cancer cells respond to the drug. The patients in these studies must have extra biopsies, scans, and blood samples. The biggest difference between phase 0 and the later phases of clinical trials is that there is no chance of a direct benefit to the patient from taking part in a phase 0 trial. Because drug doses are low, the chances of risks is less compared to the other phases of the clinical trial.

Phase 0 studies help researchers find out early which drugs do not do what they are expected to do. If there are problems with the way the drug is absorbed or acts in the body, this should become clear very quickly in a phase 0 trial. This process may help avoid the delay and expense of finding out years later in phase II or even phase III clinical trials that the drug doesn’t act as it was expected to based on lab studies.

The studies are very small, mostly with fewer than 20 people. Although this phase 0 is not a compulsory part of testing a new drug, it is used as part of an effort to speed up and streamline the process of testing new drugs.

2-Phase I clinical trials: How safe is the new treatment?

Although the treatment has been tested in lab and animal studies, the side effects in people can’t always be predicted. For this reason, these studies usually include a small number of people (15 to 50). These studies are usually done in major cancer centers.

The main reasons for doing phase I studies are to find out the highest dose of the new treatment that can be given safely (without serious side effects) and to decide on the best way to give the new treatment. The first few people in the study often get a low dose of the treatment and are watched very closely. If there are only minor side effects, the next few patients may get a higher dose. This process continues until doctors find the dose that is most likely to work while having an acceptable level of side effects.

Safety is the main concern at this point because this is usually the first time the treatment has been used in people. Doctors keep a close eye on how the people in the study are doing. They watch for any common but serious side effects. Special tests, such as blood tests to measure levels of the drug in the body at certain time points, are often a part of these clinical trials. Some studies may require time in a hospital.

These studies are not designed to find out if the new treatment works against cancer. Overall, these trials are the ones with the most potential risk. And only phase 0 has a smaller chance of helping you than phase I. But phase I studies do help some patients. For those with life-threatening illnesses like mesothelioma, weighing the potential risks and benefits carefully is needed.

3-Phase II clinical trials: How effective is the new treatment?

If a new treatment is found to be reasonably safe in phase I clinical trials, the treatment can then be tested in a phase II clinical trial to see if it works the way researchers think it will.

Usually, a group of 25 to 100 patients with mesothelioma cancer gets the new treatment in a phase II study. They are treated using the dose and method found to be most safe and effective in phase I studies. In a typical phase II clinical trial, all the volunteers usually get the same dose, and no placebo is used.

But some phase II studies do randomly assign participants to 1 of 2 treatment groups, much like what is done in phase III trials (see below). These groups may get different doses or get the treatment in different ways to see which provides the best balance of safety and effectiveness. Phase II studies are often done at major cancer centers, but may also be done in community hospitals or even doctors’ offices.

Doctors look for some evidence that the treatment works. The type of benefit or response they look for depends on the goals of the clinical trial. This may mean the tumor shrinks or disappears. Or it might mean there is an extended period of time where the tumor does not get any bigger, or there is a longer time before a cancer comes back. In some studies the benefit may be an improved quality of life. Many studies look to see if people getting the new treatment live longer than they would have been expected to without the treatment.

If a certain percentage of the patients benefit from the treatment, and the side effects aren’t too bad, the treatment is allowed to go on to a phase III clinical trial. Along with watching for responses, the research team keeps looking for any side effects. Larger numbers of patients get the treatment in phase II studies, so there is a better chance that less common side effects may be seen.

4-Phase III clinical trials: Is it better than what’s already available?

Treatments that have been shown to work in phase II studies usually must go through one more stage of testing before they are approved for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.

Phase III clinical trials usually have a large number of patients, at least several hundred. These studies are often done in many places across the country (or even around the world) at the same time. They are more likely to be offered by community-based oncologists.

Because doctors do not yet know which treatment is better, patients are often chosen at random, (called randomized) to get either the standard treatment or the new treatment. When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study.

As with other studies, patients in phase III clinical trials are watched closely for side effects, and treatment is stopped if they are too bad.
Randomization is used in many phase III studies because it helps reduce the risk that one group will be different from the other when they go into the study, which could affect outcome. Blinding reduces the risk that the doctors will be biased in their evaluations of the patients’ outcomes. These controls help make the study results more credible.

5-Phase IV clinical trials: What else is there to know about the drug?

Although a drug might have been approved for general usage, the full effects of the treatment may not be known, and their might still be some questions about the drug that are yet to be answered. For example, a drug may approved by the relevant drug regulatory authority based on the fact that it was shown to reduce the risk of cancer recurrence but does this mean that those who get it are more likely to live longer? Are there rare side effects that haven’t been seen yet, or side effects that only show up after the drug is used for a long time? These types of questions may take many years to answer fully, and may not be critical for getting a medicine to market. They are often addressed in what are known as phase IV clinical trials.

Phase IV studies look at drugs that have already been approved by the relevant drug regulatory bodies. They are already available for doctors to give to patients, but these studies are still needed to answer important questions.

When thinking about taking part in a phase IV trial, you should know that the drug has already been approved for use. The care you would get in these types of studies often is very much like what you could expect if you were to get the treatment outside of a clinical trial. You should be reassured that in taking part you would be getting a form of treatment that has already passed through different phases of testing and that you would be doing a service to future patients.

5 Important Facts About Mesothelioma Clinical Trials

5 Important Facts About Mesothelioma Clinical Trials

5 Important Facts About Mesothelioma Clinical Trials


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Home Page > Health > Cancer > 5 Important Facts About Mesothelioma Clinical Trials

5 Important Facts About Mesothelioma Clinical Trials

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5 Important Facts About Mesothelioma Clinical Trials

By: Bello Gbenga

About the Author

Bello kamorudeen.For more information on Mesothelioma treatment go to http://www.mesotheliomacancer.blogspot.com

(ArticlesBase SC #1340099)

Article Source: http://www.articlesbase.com/5 Important Facts About Mesothelioma Clinical Trials





Clinical trials are vital in studying all aspects of medicine, not just cancer. They are particularly even more important in the research for newer and more effective treatments for terminal diseases like mesothelioma cancer, but all new treatments (drugs and medical devices) actually pass through clinical trials before being approved by the relevant drug regulatory bodies. These are important facts about clinical trials:

1- All clinical trials are voluntary

Although participation in a clinical trial in the treatment of terminal diseases like mesothelioma is highly advisable it is not mandatory that you take part in them. You always have the right to choose whether or not you will take part in a clinical trial. The level of care you get should not be affected by your decision. And you have the right to leave a clinical trial at any time, for any reason. If you decide to leave, your health care team may ask that you agree to continue to be watched for a certain length of time to look for any long-term effects of treatment.

2- Not all clinical trials study treatments

Not all clinical trials are about the study of new treatments, many clinical trials study new ways to detect, diagnose, or learn the extent of disease. Some even look at ways to prevent the disease from happening in the first place.

3- Even among clinical trials that do study treatments, not all of them study drugs

Many clinical trials test other forms of treatment, such as new surgery or radiation therapy techniques, or even complementary or alternative medicines or techniques.

4- Not all clinical trails study new treatment methods

Some clinical trials are about the study of already approved drugs. Even after a drug has been approved for use against a type of cancer, doctors sometimes find it works better when given a certain way or when combined with other treatments. It may even work on a different cancer. Clinical trials are needed to study these possibilities as well.

5- Mesothelioma cancer clinical trials do not usually involve the use of a placebo

A placebo is an inactive ingredient or pill used in some types of clinical trials to help make sure results are unbiased. A placebo is sometimes called a “sugar pill.” Over the years, doctors have observed that some people begin to feel better even if they just think they’re being treated. Although this effect tends to be brief, and does not really affect a cancer, it can make a new treatment seem to help. The possibility of getting a placebo keeps people from knowing if they are getting the treatment being studied or not, which makes the results more likely to be valid.

Placebos are rarely used alone in cancer research unless no known effective treatments exist. It’s certainly not ethical to have someone take a placebo if an effective standard treatment is already available especially in the case of a grave disease like mesothelioma cancer. When cancer clinical trials compare treatments, they compare the new treatment against the current standard treatment. At times, a study may be designed so that patients may not be told which one they are getting, but they know they are at least getting treatment that meets the current standard of care.

In some clinical trials, the doctors want to learn if adding a new drug to the standard therapy makes it work better. In these studies, some patients get the standard drug(s) and a new one, while other patients get the standard drug(s) and a placebo. But none of the patients would get only a placebo. Everyone gets standard treatment if there is a standard treatment available.

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About the Author:

Bello kamorudeen.For more information on Mesothelioma treatment go to http://www.mesotheliomacancer.blogspot.com

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Mesothelioma Clinical Trial-An overview of three important clinical trials

Mesothelioma Clinical Trial-An overview of three important clinical trials

Clinical trials are used to find out whether the treatment is safe for general use and whether it is actually effective against diseases. Participation in clinical trials is an important treatment option for many patients with mesothelioma as much of the currently used treatments offer little hope for a cure.

Mesothelioma is very resistant to treatment  and medical experts believe that there could be an epidemic of mesothelioma cases in years to come. Clinical trials (research studies with people) are designed to find new treatments and better ways to use current treatments, raising hope for victims of this devastating disease. These are three important ongoing clinical trials for mesothelioma treatment.

1-Phase III Vorinostat (SAHA) clinical trial for progressive or relapsed malignant pleural mesothelioma patients. This trial is studying the use of chemotherapy drug vorinostat to kill cancerous cells and stop their division, it is also believed that the drug can inhibit enzymes that are needed by the cancerous cells for growth and multiplication. These studies are currently in the third phase to understand its effects on epithelial, sarcomatous, and recurrent mesothelioma. Phase III Vorinostat (SAHA) trials for progressive or relapsed malignant pleural mesothelioma patients are currently underway at the Jonsson Comprehensive Cancer Center at UCLA and Warren Grant Magnuson Clinical Center – NCI Clinical Studies Support, Bethesda, Maryland.

2-Phase II AZD2171 clinical trial for patients with unresectable malignant mesothelioma Phase II AZD2171 for patients with unresectable malignant mesothelioma is investigating the use of chemotherapy drugs to inhibit enzymes that slow the growth and block the supply of blood into the cancerous cells. Cancer cells depend on the formation of new blood vessels to bring blood that will supply the nutrients that they need for growth, new drugs are being studied that will inhibit the development of these new blood vessels. This study hopes to result in the development of drugs that will be used to treat epithelial, sarcomatous, advanced, and recurrent malignant mesothelioma. These clinical trials are underway in Arizona, Georgia, Illinois, Indiana, Iowa, Kansas, Massachusetts, Michigan, Missouri, Montana, North Carolina, Ohio, South Carolina, Tennessee, Virginia, Washington, and Wyoming.

3-Phase II clinical trial on the use of Pemetrexed Disodium with Gemcitabine or Carboplatin in advanced malignant mesothelioma patients. The Phase II clinical trial on the use of Pemetrexed Disodium with Gemcitabine or Carboplatin in advanced malignant mesothelioma patients clinical is a study to study the effects of chemotherapy drugs pemetrexed disodium, gemcitabine, and carboplatin on advanced and recurrent malignant mesothelioma. This study is in phase II and is being conducted in several locations across the country including Delaware, Florida Illinois, Indiana, Iowa, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, South Dakota, and Wisconsin.

Mesothelioma victims should always endeavor to ask their oncologist about available clinical trials in their area.

Bello Kamorudeen. For more information on mesothelioma clinical trials go to http://www.mesotheliomacorner.blogspot.com


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How to Choose the Best Mesothelioma Clinical Trial

How to Choose the Best Mesothelioma Clinical Trial

You can find out about good mesothelioma clinical trials in different ways. You can enter for clinical trials do so after hearing about them from your doctor. You can also actively look for clinical trials on the Internet or in other places, hoping to find more options for treatment. Some clinical trials are advertised directly to patients.

Information about mesothelioma cancer resources can be obtained from several resources. These resources can be divided into 2 main types: clinical trials lists and clinical trials matching services.

1- Clinical trial lists

These sources give you the names and descriptions of clinical trials of new treatments. If there is a study you are interested in, you will probably be able to find it in a list. The list will often include a description of the study, the criteria for patient eligibility, and a contact person. If you (or your health care providers) are willing and able to read through descriptions of all the studies listed for your cancer type, then a list may be all you need. Some organizations that provide lists can help you narrow the list a little, according to the kind of treatment you are looking for (chemotherapy, immunotherapy, radiation therapy, etc.) and the stage of your cancer.

2- Clinical trials matching services

Over the past few years, several organizations have developed computer-based systems to match patients with studies they may be eligible for. This service is often offered online.

Each may differ somewhat in how it works. Some of the services allow you to search for clinical trials without registering at the site. If you have to register, they usually assure you that your information will be kept confidential. Either way, you will probably have to enter certain details, such as the type of cancer, the stage of the disease, and any previous treatments you may have had. When given this information, these systems can find clinical trials for which you may be eligible, and save you the time and effort of reading descriptions of studies that are not relevant to you. Some groups also allow you to subscribe to mailing lists so that you are informed as new studies open up.

Although they are usually free to users, most clinical trial matching services get paid for listing studies or get a finder’s fee from those running the studies when someone enrolls. Because of this, there may be some differences in the way they rank the studies, or the order in which they present the studies to you.

Because different services work differently, be sure you understand how the service you are looking at operates. Ask the following questions. (Note that the answers do not necessarily mean that the service is not worth using.)
•Is there a fee for using the service?
•Do I have to register to use the service?
•Does the service keep my information confidential?
•Where does the service get its list of clinical trials?
•Does the service rank the studies in any particular order? Is this based on fees they get?
•Can I contact the service through the Internet or by telephone?

Examples of clinical trials matching services are:

1- The American Cancer Society Clinical Trials Matching Service:
The American Cancer Society helps patients find high quality care in clinical trials that best match their medical needs and personal preferences, while helping researchers study more effective treatments for future patients

The TrialCheck® database, developed and maintained by the Coalition of Cancer Cooperative Groups, is a comprehensive database that includes the Coalition, National Cancer Institute, and industry trials. To our knowledge, this is the most complete matching database of cancer clinical trials available.

The clinical trials information provided by the American Cancer Society is not biased in any way. It is updated every day, as is the contact information that allows patients to get in touch with the doctors and nurses at cancer centers running each of the studies.
You can access the TrialCheck at www.cancer.org (click on “Find a Clinical Trial”) or through a toll-free number, 1-800-303-5691.

2- The National Cancer Institute (NCI) sponsors most government-funded cancer clinical trials. The NCI has a list of active studies (those currently enrolling patients), as well as some privately funded studies. You can find the list on their Web site at www.cancer.gov/clinicaltrials or by calling 1-800-4-CANCER (1-800-422-6237). You can search the list by the type and stage of cancer, by the type of study (for example, treatment or prevention), or by zip code.

3- The National Institutes of Health (NIH) has an even larger database of clinical trials at www.clinicaltrials.gov, but not all of these are cancer studies.

4- EmergingMed provides a free and confidential matching and referral service for cancer patients looking for clinical trials at www.emergingmed.com, or you can call 1-877-601-8601.

5- CenterWatch (www.centerwatch.com) is a publishing and information services company that keeps a list of both industry-sponsored and government-funded clinical trials for cancer and other diseases.

6- Private companies, such as pharmaceutical or biotechnology firms, may list the studies they are sponsoring on their Web sites or offer toll-free numbers so you can call and ask about them. Some of these firms also offer matching systems for the studies they sponsor. This can be helpful if you are interested in research on a particular experimental treatment and know which company is developing it.

Bello kamorudeen.For more information on Mesothelioma treatment go to http://www.mesotheliomacorner.blogspot.com


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