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| Sponsor: | Celtic Pharma Development Services |
|---|---|
| Collaborator: |
Neurobiological Technologies |
| Information provided by: | Celtic Pharma Development Services |
| ClinicalTrials.gov Identifier: | NCT00088166 |
Purpose
The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Edema Brain Tumor |
Drug: hCRF Drug: placebo hCRF |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone |
| Estimated Enrollment: | 220 |
| Study Start Date: | May 2004 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Experimental
Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
|
Drug: hCRF
hCRF ; open-label dexamethasone that the patient is currently taking
|
|
II: Placebo Comparator
Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
|
Drug: placebo hCRF
placebo hCRF 2mg/day and open-label dexamethasone that they are taking
|
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| UC San Diego, Thornton Hospital | |
| San Diego, California, United States, 92037 | |
| UC Davis Medical Center, Division of Medical Oncology | |
| Sacramento, California, United States, 95817 | |
| Stanford University Medical Center | |
| Palo Alto, California, United States, 94305 | |
| Hoag Memorial Hospital Presbyterian | |
| Newport Beach, California, United States, 92658 | |
| UCSF Fresno Center for Clinical Studies | |
| Fresno, California, United States, 93702 | |
| United States, Colorado | |
| Colorado Neurological Institute | |
| Englewood, Colorado, United States, 80113 | |
| University of Colorado Cancer Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Cancer Institute of Orlando | |
| Orlando, Florida, United States, 32804 | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Winship Cancer Institute, Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Northwestern University, Feinberg School of Medicine | |
| Chicago, Illinois, United States, 60611 | |
| Evanston Northwestern Healthcare | |
| Evanston, Illinois, United States, 60201 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Hermelin Brain Tumor Center, Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, New Jersey | |
| Neurology Group of Bergen County | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Dent Neurologic Institute | |
| Amherst, New York, United States, 14226 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| University Hematology Oncology Care, LLC | |
| Cincinnati, Ohio, United States, 43210 | |
| Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, Oregon | |
| Oregon Clinic | |
| Portland, Oregon, United States, 97210 | |
| United States, Washington | |
| Virginia Mason Clinic | |
| Seattle, Washington, United States, 98111 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G1ZT | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| The Moncton Hospital | |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre | |
| OTTAWA, Ontario, Canada, K1H 1C4 | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Sunnybrook and Women's College Health | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Principal Investigator: | William Shapiro, MD | Barrow Neurological Institute |
More Information
| Responsible Party: | Celtic Pharma Development Services ( Patrick Rossi, MD - Medical Monitor ) |
| Study ID Numbers: | NTI 0303, XERECEPT®, corticorelin acetate injection |
| Study First Received: | July 20, 2004 |
| Last Updated: | March 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00088166 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 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 |