A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : placebo hCRF
- drug : hCRF
Phase: Phase 3
Ages Eligible For Study:
- 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