An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
This study has been completed.
Sponsor:
Celtic Pharma Development Services
Collaborator:
Neurobiological Technologies
Information provided by (Responsible Party):
Celtic Pharma Development Services
ClinicalTrials.gov Identifier:
NCT00226655
First received: September 23, 2005
Last updated: July 31, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Edema Brain Tumor |
Drug: hCRF [XERECEPT (corticorelin acetate injection)] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Corticotropin
U.S. FDA Resources
Further study details as provided by Celtic Pharma Development Services:
Primary Outcome Measures:
- Long Term Safety and Tolerability of hCRF [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]Number of patients reporting adverse events
| Enrollment: | 112 |
| Study Start Date: | July 2005 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
All patients will receive hCRF (XERECEPT) 2mg/day
|
Drug: hCRF [XERECEPT (corticorelin acetate injection)]
2mg/day
Other Name: hCRF, XERECEPT (corticorelin acetate injection)
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226655
Show 32 Study Locations
Show 32 Study LocationsSponsors and Collaborators
Celtic Pharma Development Services
Neurobiological Technologies
Investigators
| Principal Investigator: | William Shapiro, MD | Barrow Neurological Institute |
More Information
No publications provided
| Responsible Party: | Celtic Pharma Development Services |
| ClinicalTrials.gov Identifier: | NCT00226655 History of Changes |
| Other Study ID Numbers: | NTI 0501 |
| Study First Received: | September 23, 2005 |
| Results First Received: | July 31, 2012 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Celtic Pharma Development Services:
|
peritumoral brain edema edema malignant brain tumor astrocytoma |
brain tumor dexamethasone Decadron |
Additional relevant MeSH terms:
|
Brain Edema Brain Neoplasms Edema Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Signs and Symptoms Corticotropin-Releasing Hormone Dexamethasone Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013