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

Study Overview
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Brief Summary
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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.

Detailed Description
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XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Official Title
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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

Conditions
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Brain Edema, Brain Tumor

Intervention / Treatment
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* Drug: hCRF [XERECEPT (corticorelin acetate injection)]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>All patients will receive hCRF (XERECEPT) 2mg/day | Drug: hCRF [XERECEPT (corticorelin acetate injection)]<br>* 2mg/day<br>* Other names: hCRF, XERECEPT (corticorelin acetate injection);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Safety and Tolerability of hCRF | Number of patients reporting adverse events | Prospective | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron