XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
This study has been completed.
Information provided by:
Celtic Pharma Development Services
First received: July 20, 2004
Last updated: March 7, 2008
Last verified: March 2008
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.
Drug: placebo hCRF
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
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)
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088166
Celtic Pharma Development Services
||William Shapiro, MD
||Barrow Neurological Institute
No publications provided by Celtic Pharma Development Services
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Patrick Rossi, MD - Medical Monitor, Celtic Pharma Development Services
History of Changes
|Other Study ID Numbers:
||NTI 0303, XERECEPT®, corticorelin acetate injection
|Study First Received:
||July 20, 2004
||March 7, 2008
||United States: Food and Drug Administration
Keywords provided by Celtic Pharma Development Services:
peritumoral brain edema
malignant brain tumor
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Signs and Symptoms
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Peripheral Nervous System Agents
Central Nervous System Agents
Antineoplastic Agents, Hormonal