(Adapted from the Applicants Abstract): The edema that occurs in and around a brain tumor often contributes more to neurological dysfunction than the tumor itself. Dexamethasone, a corticosteroid, is the standard treatment for reducing this edema. Such treatment is associated with dose-limiting toxicities and undesirable side effects that further diminish the quality of life for brain tumor patients. An alternative therapy, such as CRF (corticotropin releasing factor), that may reduce peritumoral edema and minimize side effects would improve these patients' quality of life. This study's primary objective is to evaluate the effects of CRF administered to patients with peritumoral brain edema who require additional dexamethasone to control neurologic symptoms. Subjects with peritumoral brain edema being treated with 0-20mg daily dexamethasone are eligible to participate. The study is randomized, double-blind, positive controlled with 4 mg dexamethasone/day, triple dummy and dose- ranging (1 mg or 0.5 mg/day SC) for 15 days.Proposed Commercial Application:The number of patients suffering from peritumoral brain edema (PBE) is relatively small (<200,000/year), but they often suffer serious side effects such as muscle wasting, obesity, pathological fractures and personality changes as the result of the standard current treatment, dexamethasone. NTI was awarded orphan drug designation for hCRF by the FDA for this application (Through the present study is within an adult population, there is also much need for, and interest in, testing hCRF in a pediatric PBE population.) The need for a safe alternative to high doses of dexamethasone for treatment of the edema associated with brain tumors in significant. If treatment with hCRF exhibits safety and efficacy in brain tumor patients, this will be a very useful and marketable finding.
Thesaurus Terms:antineoplastic, brain edema, brain neoplasm, corticotropin releasing factor, human therapy evaluation, neoplasm /cancer chemotherapy combination antineoplastic therapy, dexamethasone, drug screening /evaluation, niacin clinical research, human subject, neuropsychological test
