An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
Condition: Brain Edema; Brain Tumor
MeSH terms: Brain Neoplasms; Brain Edema
Intervention: hCRF [XERECEPT (corticorelin acetate injection)]
Intervention description: 2mg/day
Intervention MeSH terms: Corticotropin-Releasing Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: peritumoral brain edema; edema; malignant brain tumor; astrocytoma; brain tumor; dexamethasone; Decadron

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.
    

Eligibility 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.