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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
peritumoral brain edema edema malignant brain tumor astrocytoma |
brain tumor dexamethasone Decadron |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Corticotropin-Releasing Hormone Astrocytoma Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Edema Central Nervous System Diseases Brain Edema |
Central Nervous System Neoplasms Brain Diseases Glucocorticoids Hormones Adrenocorticotropic Hormone Brain Neoplasms Signs and Symptoms Peripheral Nervous System Agents Glioma Nervous System Neoplasms Dexamethasone acetate |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Edema Antiemetics Central Nervous System Neoplasms Brain Edema Brain Diseases Hormones Signs and Symptoms Neoplasms by Site Therapeutic Uses |
Nervous System Neoplasms Dexamethasone acetate Antineoplastic Agents, Hormonal Corticotropin-Releasing Hormone Nervous System Diseases Gastrointestinal Agents Central Nervous System Diseases Glucocorticoids Pharmacologic Actions Brain Neoplasms Neoplasms Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |