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An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
Not Recruiting
Trial ID: NCT00226655
Purpose
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
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
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
Eligibility
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.
Intervention(s):
drug: hCRF [XERECEPT (corticorelin acetate injection)]
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lynn Adler
6507258630