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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.


Lawrence Recht, MD
Lawrence Recht, MD
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
Paul Graham Fisher, MD
Paul Graham Fisher, MD
Neuro-oncologist, Pediatric neurologist
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Laurence Katznelson, MD

Contact us to find out if this trial is right for you.


Lynn Adler