Primary outcomeNumber· Prospective
The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5
| Group | Value (participants) |
|---|---|
| hCRF | 57 |
| Placebo | 46 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataXERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
This trial does not test a peptide that PepBank tracks.
- Names ACTH (corticotropin), does not test it. It appears in the title.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 200 participants (actual)
- Sponsor
- Celtic Pharma Development Services · Industry
- Design
- Randomized · Quadruple masking
- Countries
2 countries
United States, Canada
- Start
- May 2004
- Primary completion
- Mar 2008
- Completion
- Mar 2008
- First posted
- 22 Jul 2004 (estimated)
- Last update posted
- 13 Aug 2014 (estimated)
- Conditions
- Brain Edema · Brain Tumor
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200420052006200720082009
- Ph 3
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
NCT00088166May 2004 to Mar 2008
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- hCRFDrug
- placebo hCRFDrug
Arms2
Experimental
I
Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
Placebo comparator
II
Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
Primary outcomes1
Outcomes the sponsor listed as primary.
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
Registry description
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
Secondary outcomes(8)
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
Registry description
• 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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
Numbers of patients who discontinued prior to the Week 5 assessment
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· 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
| Group | Value (participants) |
|---|---|
| hCRF | 78 |
| Placebo | 62 |
Secondary outcomeNumber· 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
| Group | Value (participants) |
|---|---|
| hCRF | 78 |
| Placebo | 62 |
Secondary outcomeMean· Prospective
Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| hCRF | -0.1 | 2.3 |
| Placebo | -0.1 | 2.7 |
Secondary outcomeMean· Prospective
Change From Baseline in the Karnofsky Performance Score
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| hCRF | -0.5 | 7.4 |
| Placebo | -2.2 | 8.5 |
Secondary outcomeMean· Prospective
Change From Baseline in the FACT-Br Quality of Life Results
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| hCRF | 0.6 | 17.5 |
| Placebo | -2.2 | 15.8 |
Secondary outcomeMean· 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)
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| hCRF | 0.1 | 2.8 |
| Placebo | -0.2 | 2.2 |
Secondary outcomeMean· Prospective
Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study
| Group | Value (Percent dexamethasone dose reduction) | Spread |
|---|---|---|
| hCRF | -62.7 | 21.8 |
| Placebo | -51.4 | 21.5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| hCRFPatients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. | – | 46 / 101 | 99 / 101 |
| PlaceboPatient will receive placebo hCRF and any open-label dexamethasone that they are currently taking | – | 40 / 99 | 97 / 99 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedRecht L, Mechtler LL, Wong ET, O'Connor PC, Rodda BE. Steroid-sparing effect of corticorelin acetate in peritumoral cerebral edema is associated with improvement in steroid-induced myopathy. J Clin Oncol. 2013 Mar 20;31(9):1182-7. doi: 10.1200/JCO.2012.43.9455. Epub 2013 Feb 4. PMID 23382470
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Histologically confirmed diagnosis of a primary malignant brain tumor or, if metastatic, documentation and histology (if available) of primary source of cancer.
* Patient must have 1 or more qualifying steroid-associated side effect(s) at Baseline.
* Patient has required administration of dexamethasone to control symptoms of peritumoral edema for at least 30 days.
* Stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to Baseline.
* Need for administration of dexamethasone to treat peritumoral brain edema (referenced above) has been documented by MRI or comparable diagnostic technology within 21 days of Baseline.
* Karnofsky score of \> 50 at Screening and Baseline.
* Capable of self-administration of subcutaneous injections twice daily for 12 weeks, or availability of assistance from caregiver.
* Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
* For women of childbearing potential: a negative serum pregnancy test at Screening.
* Must be 18 years of age or older
Exclusion Criteria:
* Ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within the first 5 weeks of study enrollment. Treatment with pre-study chemotherapy may continue.
* Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 5 weeks of treatment.
* Systemic steroid use for any indication other than peritumoral brain edema.
* Use or intended use of dexamethasone as an anti-emetic during Screening or Study
* Non-compliance with dexamethasone or anticonvulsant therapy.
* Clinical signs and symptoms of cerebral herniation.
* Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
* Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
* Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations. (Maintenance anticonvulsant therapy is allowed.)
* Central nervous system infection.
* Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
* Any conditions that are considered contraindications for patients to receive niacin, e.g. liver disease (with LFTs \> 3 times the upper limit of the norm),active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.
PepBank is a research reference. Talk to a doctor before you use any peptide.