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Leiomyosarcoma Research: Carbon Ions and Gleevec Leiomyosarcoma are rare malignant tumors or sarcomas that develop in smooth tissue cells. As the tumors can develop in so many body locations, leiomyosarcoma research tends to cover a wide range of disorders and treatment options. Gastrointestinal Stromal Tumors and Gleevec In 2002 the FDA approved the use of Gleevec (imatinib mesylate) to treat a type of leiomyosarcoma known as gastrointestinal stromal tumors, or GIST. The treatment has been approved for use in patients where surgical removal of the tumor is not possible, or in cases where the cancer has metastasized. A gastrointestinal stromal tumor is a rare sarcoma that affects approximately 5,000 to 10,000 Americans every year. The malignant cells begin in the stroma, the connective tissue that supports the digestive organs and holds them in place. Gleevec had already been FDA-approved to treat chronic myeloid leukemia, or CML. The drug works by blocking the action of enzymes that promote tumor growth. Gleevec specifically targets tumor cells that over express the enzyme tyrosine kinase. The clinical trial that led to the FDA's approval of the drug involved 147 participants. All individuals involved in the test either had gastrointestinal stromal tumors that could not be surgically removed (the medical term for such tumors is unresectable), or the cancer had metastasized and spread to other organs. Study participants were treated daily with oral administrations of Gleevec. At the end of the study, 56 of the participants (38 percent) had significant tumor size reduction of fifty percent or more. This qualified as "partial response" by medical standards. A full response would have been a complete disappearance of the tumor. Side effects were, for the most part, mild to moderate in intensity, and included the following adverse reactions: Diarrhea fluid retention (edema) liver toxin build up low blood cell counts muscle cramps nausea skin rashes vomiting. Seven study participants experienced more severe side effects. They developed hemorrhages in the tumor or gastrointestinal tract, which were treated by administering red blood cell transfusions. The study did not determine whether Gleevec improved survival rates, nor how long the effects of treatment would last. The clinical trial was made possible by the Orphan Drug Program, a federal program that offers funding for conducting research on rare diseases. Any disease that affects fewer than 200,000 people is considered rare. Gleevec was fast-tracked for use through the FDA's accelerated approval system. As a result, further tests will be required to determine how effective Gleevec is in the long-term, and whether the medication has significant medical benefits. Carbon Ion Therapy for Bone and Soft Tissue Sarcomas A study published in the November 15, 2002 Journal of Clinical Oncology investigated the uses of carbon ion beam therapy to treat bone and soft tissue sarcomas. Carbon ion therapy is a form of radiation therapy. The researchers chose carbon ion therapy because it did not "scatter," or disperse much when it came into contact with tissue, and delivered "enormous" energy to the target location. The study was undertaken by the National Institute of Radiological Sciences, Chiba, Japan, and led by Dr. Tadashi Kamada. Fifty-seven people took part in the study. The participants had a total of 64 bone or soft tissue sarcomas. Tumor location among the patients was divided up as follows: pelvic tumors: 32 spinal or paraspinal tissue tumors: 19 tumors of the extremities (arms, legs, hands, feet): 6. The study was a Phase I clinical trial to determine whether the therapy warranted further study and was safe for use. Patients received four weeks of treatment, and their progress was followed for at least eighteen months. Acute side effects were uncommon, although seven out of the seventeen participants who received high doses of carbon ions did develop adverse skin reactions. After treatment, the average survival rate was 31 months. The one-year survival rate of 82 percent was very encouraging. Three years after treatment, survival rates had dropped to 46 percent. Overall, Dr. Kamada and other researchers were positive about the initial results, and are planning a Phase II trial to continue their studies. The test indicated that carbon ion therapy was successful in controlling local tumors and improved overall survival rates. The hope is that if this treatment proves successful for these types of sarcomas, perhaps this type of therapy will be effective at treating leiomyosarcomas as well. Challenges to Leiomyosarcoma Clinical Trials More than fifty types of soft tissue sarcoma have been documented. Each must be individually researched, evaluated and treated. A therapy that treats GIST may have no effect on a sarcoma that affects the blood vessels. As a result, funding for leiomyosarcoma is often stretched thin, a difficulty compounded by the overall lack of funding for rare diseases. Programs such as the federally sponsored Orphan Drug Program help to a degree but, sadly, leiomyosarcoma funding is limited. Even with funding, researchers have difficulty in recruiting participants for clinical trials because of the rarity of the disease. Only a small percentage of diagnosed patients volunteer for clinical trails. If you have been diagnosed with a leiomyosarcoma, please consider giving your time to a clinical trail. Participating in a clinical trial may make a vast difference to both your current and future treatment options. Resources Reuters Health Information. (2002). Carbon ion radiotherapy helpful in unresectable sarcomas . Retrieved May 13, 2003 from www.cancersource.com/NewsFeatures/News/detail.cfm? DiseaseID=26&ContentID=26259. U.S. Food and Drug Information. (2002). FDA approves Gleevec to treat gastrointestinal stromal cancer. Retrieved May 13, 2003, from www.fda.gov/bbs/topics/ANSWERS/2002/ANS01134.html.

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