XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

Inclusion Criteria:

• Histologically confirmed diagnosis of a primary malignant brain tumor or, ifmetastatic, 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 ofperitumoral 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 (referencedabove) has been documented by MRI or comparable diagnostic technology within 21 daysof Baseline.

• Karnofsky score of > 50 at Screening and Baseline.

• Capable of self-administration of subcutaneous injections twice daily for 12 weeks, oravailability of assistance from caregiver.

• Ability to provide written informed consent or, if unable to provide, have a legalguardian 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 theintroduction of new chemotherapeutic regime within the first 5 weeks of studyenrollment. Treatment with pre-study chemotherapy may continue.

• Concurrent enrollment in any other investigational drug or device study, or plan toenroll 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 endocrinemetabolic disease which could put the patient at unusual risk for study participation.

• Confounding previous or concurrent neurological disorders that would interfere withadequate clinical evaluation.

• Clinically significant head injury or chronic seizure disorder, if the conditionresults 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, forwomen 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 pepticulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.