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

Not Recruiting

Trial ID: NCT00226655


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

Stanford Investigator(s)

Lawrence Recht, MD
Lawrence Recht, MD

Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Paul Graham Fisher, MD
Paul Graham Fisher, MD

Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health


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

   - 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.


drug: hCRF [XERECEPT (corticorelin acetate injection)]

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lynn Adler

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