A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma

Inclusion Criteria:

- Histologically confirmed diagnosis of a primary malignant glioma.

- Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone
treatment.

- If a patient is on dexamethasone for treatment of symptomatic peritumoral brain
edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days
prior to Baseline.

- Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic
technology obtained within 21 days of Baseline.

- Capable of self-administration of subcutaneous injections twice daily for 8 weeks or
availability of assistance from caregiver.

Exclusion Criteria:

- Need for surgery, radiosurgery or radiation therapy or the introduction of new
chemotherapeutic regime within 2 weeks of study treatment.

- Systemic steroid use for any other indication than peritumoral brain edema.

- Patients on dexamethasone or anticonvulsant therapy.

- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine
metabolic disease which could put the patient at unusual risk for study
participation.

- Central nervous system (CNS) infection.

- Conditions that are considered contradictions for patients to receive niacin