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| ID | Type | Description | Link |
|---|---|---|---|
| corticorelin acetate injection |
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Alternate study projected to assess imaging endpoints versus clinical endpoints.
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| Name | Class |
|---|---|
| Neurobiological Technologies | INDUSTRY |
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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.
XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hCRF | Drug | hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the proportion of responders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2. | Prospective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Shapiro, MD | Barrow Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| UC San Diego Cancer Center |
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| placebo hCRF | Drug | placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking |
|
|
| La Jolla |
| California |
| 92093 |
| United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Moffitt Cancer Center and Research | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | United States |
| Beth Israel Deaconess Med Center | Boston | Massachusetts | 02215 | United States |
| Field Neurosciences Institute | Saginaw | Michigan | 48604 | United States |
| Neurology Group of Bergen County | Ridgewood | New Jersey | 07450 | United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27106 | United States |
| University Hematology Oncology Care, LLC | Cincinnati | Ohio | 43210 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Clinic | Portland | Oregon | 97210 | United States |
| Methodist Healthcare - University Hospital | Memphis | Tennessee | 38103 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3596 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G1ZT | Canada |
| Ottawa Regional Cancer Centre | Ottawa | Ontario | K1H 1C4 | Canada |
| ID | Term |
|---|---|
| D001929 | Brain Edema |
| D001932 | Brain Neoplasms |
| D004487 | Edema |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D003346 | Corticotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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