XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00088166|
Recruitment Status : Completed
First Posted : July 22, 2004
Results First Posted : August 13, 2014
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Brain Edema Brain Tumor||Drug: hCRF Drug: placebo hCRF||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
hCRF ; open-label dexamethasone that the patient is currently taking
Other Name: XERECEPT (corticorelin acetate injection); hCRF
Placebo Comparator: II
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
Other Name: XERECEPT (corticorelin acetate injection)
- The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5 [ Time Frame: Prospective ]
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
- 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 [ Time Frame: Prospective ]• 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.
- Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation) [ Time Frame: Prospective ]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.
- Change From Baseline in the Karnofsky Performance Score [ Time Frame: Prospective ]
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
- Change From Baseline in the FACT-Br Quality of Life Results [ Time Frame: Prospective ]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)
- Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit) [ Time Frame: Prospective ]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).
- Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study [ Time Frame: Prospective ]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.
- Number of Patients Who Discontinued Study Drug Prior to the End of Week 5 [ Time Frame: Prospective ]Numbers of patients who discontinued prior to the Week 5 assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088166
|Principal Investigator:||William Shapiro, MD||Barrow Neurological Institute|