One of the frustrating facts about malignant mesothelioma is the resistance of the cancer cells generated by the disease to chemotherapy and radiotherapy treatment. Physicians are constantly testing new medications as well as entirely new concepts for slowing or halting the reproduction of malignant cells, as well as methods of destroying them. New uses of established technology come into play, such as the development of the intensity modulated radiation technique for radiotherapy. Gene therapy and immunotherapy both attempt to utilize the body's natural methods of fighting invasive disease for the purpose of targeting cancer cells.
Much of the testing for new treatment modalities centers on chemotherapy: both new drugs and new methods of delivering the medication effectively to the diseased tissue. All new medications to be sold in the United States must go through a clinical trial process prior to being approved by the Food and Drug Administration (FDA). In many cases, anti-cancer drugs used for mesothelioma treatment are medications that have been expressly approved for a form of cancer treatment, but not for use with mesothelioma. Using an approved cancer drug for a non-approved cancer treatment is not unusual, nor illegal under FDA guidelines.
Clinical trials are also conducted simply to see if there are better treatment options to be found using tools that are already available for fighting cancer. That's why many clinical trials for mesothelioma are experiments to see if the use of existing cancer drugs in one combination or another will be effective in combating asbestos cancer. Aside from FDA approval, a properly conducted clinical trial will establish the clear value of one form of treatment or another because it meets the professional medical standards for such tests.
Clinical Trial Phases
There are clearly defined stages for any clinical trial, guidelines that are set down by the administrative body charged with oversight. In the United States those bodies are the FDA and the Department of Health and Human Services. One of these agencies will designate an Institutional Review Board (IRB) for management of a particular trial. Generally they are funded by biotech or drug companies for commercial purposes, or by the National Institutes of Health for research purposes. This is the model for a clinical trial:
Phase I: The initial treatment study is conducted on a small group of people, often healthy volunteers, to determine the upper safe limit of a drug and to learn how it is processed by the body. Participants are closely observed through the half life of the medication or treatment concept being tested.
Phase II: Larger groups of patients are given the treatment to confirm whether the treatment is effective and to further study the treatment's safety profile. It is in this phase that the effectiveness of a drug or treatment comes into focus, as it is being used with patients who will or will not respond to its use. There is continued monitoring for safety characteristics in this phase as well. At this stage the use of randomized patient selection is often applied, providing one group of patients with the actual medication being tested and another group with a placebo. This is the most effective clinical trial technique for measuring the value of the treatment being tested.
Phase III: Very large groups of patients are studied to compare the new treatment with existing treatments and collect data about the treatment's safety. This stage usually occurs at multiple treatment sites so that sufficient numbers of patients may be involved. Physicians and clinical technicians at the various sites follow a strict protocol.
Phase IV: After the FDA issues an initial approval for a drug or treatment additional testing is required. That is the final phase, which can continue for months or more after a medication is in circulation and use. If controversy develops about a new drug or treatment the FDA may request additional trials well after the product has been on the market.
Risks of Mesothelioma Clinical Trials
The survival time after diagnosis of mesothelioma has historically been dismally short, which means that for many participants in mesothelioma clinical trials the treatment won't be a decisive factor in their personal history with the disease. Nevertheless mesothelioma cancer patients that are selected for a clinical trial may or may not be the fortunate recipients of an effective new treatment; they may show no response to the treatment at all. There is also the possibility of an adverse reaction, although Phase I should help to reduce the likelihood.
There is also the possibility that patients will not be receiving the medication being tested, but will be one of the group receiving a placebo. Participants are never informed which is the case. It is one of the uncertainties associated with the protocols used for testing medical treatments: the "randomized, double-blind, placebo-controlled study."
Learning About Clinical Trials
The selection of participants for a clinical trial is based on a strict set of guidelines that involve the patient's health, treatment history and many other factors. If you're considering participating in a mesothelioma clinical trial there are some questions you should ask as well. Some of these seem obvious, but sometimes patients with a terminal disease are anxious for new treatment options and lose sight of the obvious. Questions to ask:
- Who is funding the trial?
- History of the drugs/treatment being tested?
- The length of the trial?
- The patient profile for the treatment group?
- What IRB is monitoring the trial?
- Are there perceived personal medical risks?
- Are there any personal costs associated with participation?
- How often do participants report for treatment?
There aren't any guarantees with clinical trials, and there isn't going to be a cure for mesothelioma anytime soon. But it is important for each participant to determine whether or not a clinical trial can pose a threat to one's current health status. Late stage mesothelioma patients may wish to participate in a clinical trial, or may wish to stay with existing palliative treatment and avoid the possibility of further physical difficulties.
Finding Mesothelioma Clinical Trials
The physician who diagnosed your mesothelioma may be able to refer you to an appropriate mesothelioma clinical trial. You can also check the websites of the U.S. National Institutes of Health (NIH) and the National Cancer Institute (NCI); each has a registry of clinical trials for cancer treatments.
- Questions & Answers about Clinical Trials, U.S. Food & Drug Administration, http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm121345.htm
- Understanding Clinical Trials, National Institutes of Health, http://clinicaltrials.gov/ct2/info/understand#Q19
- FAQs about Clinical Studies, NIH Clinical Center, http://www.cc.nih.gov/participate/faqaboutcs.shtml
- National Institutes of Health Clinical Trials, http://clinicaltrials.gov/ct2/search
- National Cancer Institute, http://www.cancer.gov/clinicaltrials