Status:
COMPLETED
An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
Lead Sponsor:
Celtic Pharma Development Services
Collaborating Sponsors:
Neurobiological Technologies
Conditions:
Brain Edema
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritum...
Detailed Description
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Eligibility Criteria
Inclusion
- Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
- Have a Karnofsky Performance of \> 50 at Baseline
- Capable of self-administration of subcutaneous injections twice daily 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 Baseline
Exclusion
- Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
- Systemic steroid use for any indication other than peritumoral brain edema.
- Use or intended use of dexamethasone as an anti-emetic during study.
- 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 during 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 (CNS) infection.
- Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00226655
Start Date
July 1 2005
End Date
April 1 2009
Last Update
August 31 2012
Active Locations (32)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
3
Stanford University Medical Center
Palo Alto, California, United States, 94305
4
UC Davis Medical Center, Division of Medical Oncology
Sacramento, California, United States, 95817