Griffith Harsh
XERECEPT? (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: hCRF
- Drug: placebo hCRF
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
- Capable of self-administration of subcutaneous injections twice daily for 12 weeks, or availability of assistance from family/friend.
Key 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.
- 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
- Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
- 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.)
- Any conditions that are considered contraindications for patients to receive niacin
Additional Study Details
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 DexamethasoneAnticipated start date:
5/17/2005Lead Sponsor:
Neurobiological TechnologiesCollaborator(s):
- Celtic Pharma Development Services
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- The proportion of patients in each treatment group who are Responders at Week 2 and continue at Week 5
Secondary Outcomes:
- 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
- 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
- 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).
- 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)
- 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)
- Change from Baseline in the FACT-Br quality of life results at Weeks 5, 12 (or Early Study Drug Discontinuation), and 16
- Change from Baseline in Myopathy assessment results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up visit)
- Maximum percent reduction in dexamethasone usage relative to Baseline achieved during the study
- Time to discontinuation of blinded study medication prior to the end of Week 5
Total Number to be Enrolled:
200Total Number to be Enrolled at Stanford:
12More Information
Secondary ID(s):
- 96043
- BRN0001
- NCT00088166
- NTI 0303
- XERECEPT
- corticorelin acetate injection
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/31/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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