xerecept® (hcrf) for patients requiring dexamethasone to treat edema associated with brain tumors

Conditions: Brain Edema; Brain Tumor

Summary: the purpose of this study is to compare the safety and efficacy of xerecept® to dexamethasone (decadron) a common treatment for symptoms of brain swelling (edema). this study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

xerecept® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of a primary malignant brain tumor or, if metastatic, documentation and histology (if available) of primary source of cancer. * patient must have 1 or more qualifying steroid-associated side effect(s) at baseline. * patient has required administration of dexamethasone to control symptoms of peritumoral edema for at least 30 days. * stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to baseline. * need for administration of dexamethasone to treat peritumoral brain edema (referenced above) has been documented by mri or comparable diagnostic technology within 21 days of baseline. * karnofsky score of \> 50 at screening and baseline. * capable of self-administration of subcutaneous injections twice daily for 12 weeks, or availability of assistance from caregiver. * ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent. * for women of childbearing potential: a negative serum pregnancy test at screening. * must be 18 years of age or older exclusion criteria: * ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within the first 5 weeks of study enrollment. treatment with pre-study chemotherapy may continue. * concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 5 weeks of treatment. * systemic steroid use for any indication other than peritumoral brain edema. * use or intended use of dexamethasone as an anti-emetic during screening or study * non-compliance with dexamethasone or anticonvulsant therapy. * clinical signs and symptoms of cerebral herniation. * serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation. * confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation. * clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations. (maintenance anticonvulsant therapy is allowed.) * central nervous system infection. * pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential. * any conditions that are considered contraindications for patients to receive niacin, e.g. liver disease (with lfts \> 3 times the upper limit of the norm),active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.

Keywords: peritumoral brain edema edema malignant brain tumor astrocytoma brain tumor dexamethasone decadron