An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

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

Inclusion criteria

• Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
• Have a Karnofsky Performance of > 50 at Baseline
• Capable of self-administration of subcutaneous injections twice daily 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 Baseline

Exclusion criteria

• Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
• Systemic steroid use for any indication other than peritumoral brain edema.
• Use or intended use of dexamethasone as an anti-emetic during study.
• Clinical signs and symptoms of cerebral herniation.
• Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk during study participation.
• Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
• Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)
• Central nervous system (CNS) infection.
• Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.