An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.
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 : hCRF [XERECEPT (corticorelin acetate injection)]
Phase: Phase 3
Ages Eligible For Study:
- 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