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.
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
hCRF ; open-label dexamethasone that the patient is currently taking
placebo hCRF 2mg/day and open-label dexamethasone that they are taking
The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5
The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following: * 50% or greater reduction in dexamethasone dose relative to Baseline * Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline * Karnofsky Score unchanged or increased relative to Baseline
Time frame: Prospective
Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS
Time frame: Prospective
The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8
• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.
Time frame: Prospective
Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)
Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.
Time frame: Prospective
Change From Baseline in the Karnofsky Performance Score
Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment nec
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Barrow Neurological Institute
Phoenix, Arizona, United States
UCSF Fresno Center for Clinical Studies
Fresno, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford University Medical Center
Palo Alto, California, United States
UC Davis Medical Center, Division of Medical Oncology
Sacramento, California, United States
UC San Diego, Thornton Hospital
San Diego, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Cancer Institute of Orlando
Orlando, Florida, United States
...and 24 more locations
Time frame: Prospective
Change From Baseline in the FACT-Br Quality of Life Results
The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)
Time frame: Prospective
Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)
Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).
Time frame: Prospective
Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study
The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.
Time frame: Prospective
Number of Patients Who Discontinued Study Drug Prior to the End of Week 5
Numbers of patients who discontinued prior to the Week 5 assessment
Time frame: Prospective