Tolerability Study of Xerecept® in Pediatric Patients

Inclusion Criteria

• •1. Have histologically confirmed primary, recurrent or metastatic cerebral tumors and require chronic steroid dosing to manage symptoms of peritumoral brain edema (No histological confirmation is required of optic pathway tumors or brain stem gliomas)
• •2. Have been taking dexamethasone (or equivalent) at a dose of ≥1 mg/day for a minimum of 14 days and have had a stable dose for at least 7 days.
• •3. Have one or more steroid-associated side effects at Screening (See Appendix A1 for a list of qualifying events)
• •4. Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver.
• •5. Karnofsky/Lansky performance status ≥ 40
• •6. Life expectancy of at least 6 months
• •7. Female subjects must not be pregnant or breast-feeding and, if of childbearing potential, must use adequate methods of contraception during the study
• •10\. Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed