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Clinical trials for leiomyosarcoma (LMS) were discussed briefly Oct. 8 at the National Leiomyosarcoma Foundation patient symposium in St. Louis, Mo. This was one of several cancer treatment topics that I will be reporting about during the coming weeks.
Dr. Peter Oppeli, assistant professor of medicine at the Washington University School of Medicine, said LMS is one of the more common types of soft-tissue sarcoma. It is found in smooth muscle cells that naturally occur in the intestines, blood vessels, and the uterus, all of which are in charge of involuntary action in the body. For pregnant women, these muscles play a key role in labor and delivery.
LMS can originate anywhere smooth muscles are found. In almost half of all new LMS diagnoses, it is found in the uterus. It also occurs in the body’s extremities and in the abdominal cavity, especially in the back part of the abdomen.
There are about 2,000 new diagnoses each year. Compare that to another type of cancer, such as colon, which has about 135,000 new diagnoses each year.
Because LMS is rare, it is more challenging to come up with treatments. Any new drug for a rare disease is cause for a lot of excitement. Trabectadine, for example, was approved by the FDA in October 2015.
New drugs are approved when they show proven benefit from a clinical trial.
Clinical trials are research studies for understanding cancer and how to treat it. Trials can look at new drugs, combinations of drugs, ways to ease side effects, new forms of radiation, and new surgical methods.
A Phase 1 clinical trial is for finding the right dose and finding out the treatment’s side effects.
A Phase 2 trial involves larger groups of patients. In a Phase 3 trial, large number of patients are treated to confirm effectiveness.
The vast majority of clinical trials do not have a placebo-only option. Placebos usually are combined with standard effective treatment, so every patient gets what is determined to be the best treatment.
What is research protocol? It is the rule book for each clinical trial. Each trial will have a unique/specific protocol that describes inclusion and exclusion criteria for potential treatment.
Is a clinical trial going to help a particular patient? “We hope so, but cannot say with certainty that enrolling is going to be beneficial,” Dr. Oppeli said.
Almost every standard treatment has first been proven effective in clinical trials.
After his talk there was a 10-minute time period for questions.
A lot of clinical trials have interim times to see if a trial is helpful or not. Then if not shown effective, the trial is stopped. If the results look promising, the trial continues.
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For more information on clinical trials, go to www.cancer.net for a large video library.