Primary brain tumors, such as glioblastoma multiforme and astrocytoma, generally are resistant to chemotherapy, surgery, and radiation. Chemotherapeutic agents have not met with great clinical success, as they are unable to cross the blood-brain barrier and reach the site of the tumor. As a result, several new treatments for the management of brain tumors are now under clinical investigation in the United States; none of these new treatments is readily available yet for widespread use. Temodol(temozolomide), one of the experimental agents, is being tested against brain tumors at several U. S. cancer centers.
Temodal is unique in that it is the first oral chemotherapeutic agent found to cross the blood-brain barrier. The drug has demonstrated significant anticancer effects on tumor cells in the test tube as well as in animals. One important advantage of Temodal is its ability to convert spontaneously to a highly reactive agent that kills tumor cells; thus, Temodal acts by directly interfering with the growth of a tumor. In contrast, many other chemotherapeutic agents require metabolic activation to exert their effects and, hence, their clinical activity may vary from patient to patient. For these reasons, Temodal is being tested in patients with primary brain tumors.
A number of Phase I/II trials of Temodal in adults and children with advanced cancer have been completed, and further international evaluations of Temodal are ongoing. Results of Phase II trials in Europe and the United Kingdom have shown that oral Temodal is safe, well tolerated, and efficacious against malignant glioma (anaplastic astrocytoma and glioblastoma multiforme). These studies were performed in more than 100 patients with malignant glioma. Clinical responses were measured by improvement in neurologic status, and objective responses were observed in a number of patients. Further randomized studies are needed to determine if these results translate into improved survival rates. Most adverse events noted in these studies were mild to moderate in severity and included a diminished white cell count, nausea, vomiting, headache, and tiredness or lethargy.
A multi center Phase II trial of Temodal now under way in the United States is seeking to confirm the safety and efficacy of Temodal demonstrated in previous clinical trials and evaluate the drug against malignant glioma after a first relapse. This randomized trial, the results of which are still pending, involves administration of oral doses of Temodal 750 to 1000 mg/m2/ per day for 5 days repeated every 28 days.
For information on open Temodal trials as well as patient enrollment criteria, please call 1 800-422-6237 (Cancer).
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