| July 20, 2004 |
| March 7, 2008 |
| May 2004 |
| March 2008 (final data collection date for primary outcome measure) |
| The proportion of patients in each treatment group who are Responders at Week 2 and continue at Week 5 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ] |
| The primary efficacy endpoint is the proportion of reponders, i.e. patients in each treatment group who show improvement at the end of Week 2. |
| Complete list of historical versions of study NCT00088166 on ClinicalTrials.gov Archive Site |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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). [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
- Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5,
8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week Follow-up
visit) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
- Change from Baseline in the Signal Symptom Score at Weeks 2, 5, 8, 12
(or Early Study Drug Discontinuation), and 16 (or 4-week Follow-up visit) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
- Change from Baseline in the FACT-Br quality of life results at Weeks 5, 12
(or Early Study Drug Discontinuation), and 16 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Maximum percent reduction in dexamethasone usage relative to Baseline
achieved during the study [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
- Time to discontinuation of blinded study medication prior to the end of
Week 5 [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors |
| 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 |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
|
|
- Drug: hCRF
- Drug: placebo hCRF
|
- Experimental: Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
- Placebo Comparator: Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
|
| |
| |
| Completed |
| 220 |
| March 2008 |
| March 2008 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00088166 |
| Patrick Rossi, MD - Medical Monitor, Celtic Pharma Development Services |
| NTI 0303, XERECEPT®, corticorelin acetate injection |
| Celtic Pharma Development Services |
| Neurobiological Technologies |
| Principal Investigator: |
William Shapiro, MD |
Barrow Neurological Institute |
|
|
| Celtic Pharma Development Services |
| March 2008 |