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XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
Not Recruiting
Trial ID: NCT00226668
Purpose
The purpose of this study is to examine the safety and efficacy of XERECEPT (human
Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary
malignant glioma who require increased dexamethasone doses to control symptom of peritumoral
brain edema.
Official Title
A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma
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:
- Histologically confirmed diagnosis of a primary malignant glioma.
- Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone
treatment.
- If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema,
the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to
Baseline.
- Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic
technology obtained within 21 days of Baseline.
- Capable of self-administration of subcutaneous injections twice daily for 8 weeks or
availability of assistance from caregiver.
Exclusion Criteria:
- Need for surgery, radiosurgery or radiation therapy or the introduction of new
chemotherapeutic regime within 2 weeks of study treatment.
- Systemic steroid use for any other indication than peritumoral brain edema.
- Patients on dexamethasone or anticonvulsant therapy.
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine
metabolic disease which could put the patient at unusual risk for study participation.
- Central nervous system (CNS) infection.
- Conditions that are considered contradictions for patients to receive niacin
Intervention(s):
drug: hCRF
drug: placebo hCRF
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cathy Recht
6507258630