• The primary efficacy endpoint is the proportion of reponders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2. Improvement is defined as:
• -Lower overall score on the 10-item Neurological Exam of at least 25% relative to Baseline, and
• -Karnofsky Performance Score unchanged or increased relative to Baseline, and
• -No post-Baseline increase in dexamethasone dose on more than 1 day, with a maximum allowable increase of less than 4mg on that day.

The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

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

• Brain Edema
• Brain Tumor

• Drug: hCRF
  hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
  Other Name: XERECEPT (corticorelin acetate injection)
• Drug: placebo hCRF
  placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
  Other Name: placebo XERECEPT (corticorelin acetate injection)

• I: Experimental
  Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
  Intervention: Drug: hCRF
• II: Placebo Comparator
  Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
  Intervention: Drug: placebo hCRF

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