PERITUMORAL BRAIN EDEMA IN PATIENTS WITH MALIGNANT BRAIN TUMOR

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: Human corticotropin-releasing factor (hCRF) can partially or totally replace Dexamethasone for the treatment of peritumoral brain edema. Goals: Corticosteroids (predominantly Dexamethasone) have been used in the treatment of brain tumors and associated peritumoral brain edema for more than 30 yrs despite the severe and detrimental endocrine effects associated with long-term use and high doses. Among these effects are severe myopathies, muscle wasting, morbid weight gain, osteoporosis, gastrointestinal bleeding, and personality changes. Recent experimental findings also indicate that Dexamethasone interferes with apoptotic death of malignant glioma cells, and thereby induces resistance to commonly used chemotherapies and radiation therapy. The objective of this study is to examine the safety and efficacy of hCRF in patients with malignant brain tumor who require chronic administration of high dose Dexamethasone to control signs and symptoms of peritumoral brain edema. Experimental Design: Two hundred patients, randomized to one of two treatment groups, will participate in this double-blind, placebo-controlled, study. Patient randomization will be stratified by: primary or metastatic tumor, open-label Dexamethasone dose at baseline (4-<8, 8-16 or 17-24 mg/day), and Karnofsky Performance Scale (50-70 or 80-100).