Leukemia

 

Leukemia Clinical Trials

The battle to cure leukemia rages daily throughout America. The frontline of leukemia treatment remains in laboratories and in controlled, cutting edge experiments called “clinical trials.” These research studies rely on volunteers to test a variety of treatments ranging from alternative medicine to groundbreaking treatments like immunotherapy (also called “biological therapy”) which boosts the body’s immune system to fight cancer (instead of attacking the leukemia cells with radiation or chemicals).

Thousands of cancer clinical trials are offered every year. Here is the information and facts you should know before choosing to enroll in a clinical trial.

What are Clinical Trials?

Clinical trials are studies that use humans to test medical treatments. These studies are frequently registered with the Food and Drug Administration (FDA) and follow the agency’s guidelines for safety and experiment design. Clinical trials are also subject to approval from the human subject testing committee of the medical institution hosting the clinical trial and an Institutional Review Board (IRBs) of at least five members.

Before a new drug or treatment can make it to market, it must first pass a series of clinical trials broken into three phases:

  • phase I. As the first of the three phases, this stage helps determine the amounts (time schedule and quantity) of treatment appropriate for humans. Because this amount can only be estimated from the animal studies leading up to the clinical trial, phase I studies are the most dangerous.

  • phase II. After a cancer treatment has shown itself helpful to human health in phase I, it passes on to phase II. Typically, phase II clinical trials have more participants (several hundred people) to help with its primary goal of uncovering any unpredicted side effects in the treatment. In recent years, the FDA has pushed for more women and nonwhites to participate in phase II and phase III trials in an effort to draw out those dangers to minority populations previous tests would not have found.

  • phase III. If phase II clinical trials show the effectiveness of a treatment, the treatment then passes into phase III. Though the final phase, many phase III trials may be run on a single treatment to ensure its safeness and to compare its results with the best therapy presently available. Phase III clinical trials include hundreds to thousands of participants whose reactions to treatment help set the treatment’s warning information if and when the treatment is approved.

Risks of Clinical Trials

Before enrolling in any study, it is important to know which of the three phases the treatment is in, to get an official report of the study, and to know the background of the institute or company conducting the clinical trial. Pharmaceutical companies [link to Drug Recall landing pg] have been known to take unnecessary risks with humans in order to get their drugs to market. Be careful, and do your research.

Any clinical study you are considering should have an endpoint, that is, a definite marker and fixed time schedule set by the experimenters to determine if the treatment is a success or failure. If no stop point is given, then don’t start. Any clinical trial without clear and rigid standards should be treated with extreme suspicion.

Please note that just because a treatment is new or “experimental,” this does not mean it is more effective than current treatments. Most, in fact, are not. As in the case of shark cartilage powder, popularized by the 1992 book Sharks Don’t Get Cancer, shark cartilage protein did not show enough benefits to pass phase II testing.

Help Paying for a Clinical Trial

Medicare patients can have most, if not all, costs of their experimental treatments covered by their government insurance if the clinical trial is funded by The National Cancer Institute (NCI) or another federal government agency. Medicare does not pay for clinical trials that are not related to treating your cancer. To learn if Medicare will cover your costs, call them at 1-800-MEDICARE.

Additionally, The Leukemia Society of America supports cancer research and helps patients with leukemia by providing both money and information to patients interested in clinical trials. Their toll-free number is 1-800-955-4LSA.

How You Can Help

The National Cancer Institute (NCI) predicts that if 10% of cancer patients participated in clinical trials, the effectiveness of a new therapy could be determined in one year. Presently, with less than 5% participation from cancer patients, a single clinical trial takes 3 to 5 years to complete.

If you would like to determine if you qualify for a clinical trial in your area, please call Cancer Information Service (CIS) at 1-800-4-CANCER to speak with a live information specialist.

 

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