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Sponsors and Collaborators: |
Celtic Pharma Development Services Neurobiological Technologies |
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Information provided by: | Celtic Pharma Development Services |
ClinicalTrials.gov Identifier: | NCT00226668 |
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.
Condition | Intervention | Phase |
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Brain Edema Brain Tumor |
Drug: hCRF Drug: placebo hCRF |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
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I: Experimental
Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
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Drug: hCRF
hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
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II: Placebo Comparator
Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
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Drug: placebo hCRF
placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
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XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | William Shapiro, MD | Barrow Neurological Institute |
Responsible Party: | Celtic Pharma Development Services ( Patrick Rossi, MD - Medical Monitor ) |
Study ID Numbers: | NTI 0302, corticorelin acetate injection |
Study First Received: | September 23, 2005 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00226668 |
Health Authority: | United States: Food and Drug Administration |
peritumoral brain edema edema malignant brain tumor astrocytoma |
brain tumor dexamethasone Decadron |
Dexamethasone Corticotropin-Releasing Hormone Astrocytoma Edema Central Nervous System Diseases Brain Edema Central Nervous System Neoplasms |
Brain Diseases Adrenocorticotropic Hormone Brain Neoplasms Signs and Symptoms Glioma Nervous System Neoplasms Dexamethasone acetate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Glucocorticoids |
Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |