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An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226655
Recruitment Status : Completed
First Posted : September 27, 2005
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Neurobiological Technologies
Information provided by (Responsible Party):
Celtic Pharma Development Services

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 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 or disease Intervention/treatment Phase
Brain Edema Brain Tumor Drug: hCRF [XERECEPT (corticorelin acetate injection)] Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: I
All patients will receive hCRF (XERECEPT) 2mg/day
Drug: hCRF [XERECEPT (corticorelin acetate injection)]
Other Name: hCRF, XERECEPT (corticorelin acetate injection)

Primary Outcome Measures :
  1. Long Term Safety and Tolerability of hCRF [ Time Frame: Prospective ]
    Number of patients reporting adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226655

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Sponsors and Collaborators
Celtic Pharma Development Services
Neurobiological Technologies
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Principal Investigator: William Shapiro, MD Barrow Neurological Institute
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Responsible Party: Celtic Pharma Development Services Identifier: NCT00226655    
Other Study ID Numbers: NTI 0501
First Posted: September 27, 2005    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: August 31, 2012
Last Verified: July 2012
Keywords provided by Celtic Pharma Development Services:
peritumoral brain edema
malignant brain tumor
brain tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Brain Edema
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Corticotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs