XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
Condition: Brain Edema; Brain Tumor
MeSH terms: Brain Neoplasms; Brain Edema; Edema
Intervention: hCRF; placebo hCRF
Intervention description: hCRF ; open-label dexamethasone that the patient is currently taking; placebo hCRF 2mg/day and open-label dexamethasone that they are taking
Intervention MeSH terms: Corticotropin-Releasing Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
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 compare the safety and efficacy of XERECEPT® to dexamethasone
      (Decadron) a common treatment for symptoms of brain swelling (edema). This study is
      specifically aimed at patients who require chronic high doses of dexamethasone to manage
      symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of a primary malignant brain tumor or, if
             metastatic, documentation and histology (if available) of primary source of cancer.

          -  Patient must have 1 or more qualifying steroid-associated side effect(s) at Baseline.

          -  Patient has required administration of dexamethasone to control symptoms of
             peritumoral edema for at least 30 days.

          -  Stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to Baseline.

          -  Need for administration of dexamethasone to treat peritumoral brain edema (referenced
             above) has been documented by MRI or comparable diagnostic technology within 21 days
             of Baseline.

          -  Karnofsky score of > 50 at Screening and Baseline.

          -  Capable of self-administration of subcutaneous injections twice daily for 12 weeks, 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 Screening.

          -  Must be 18 years of age or older

        Exclusion Criteria:

          -  Ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the
             introduction of new chemotherapeutic regime within the first 5 weeks of study
             enrollment. Treatment with pre-study chemotherapy may continue.

          -  Concurrent enrollment in any other investigational drug or device study, or plan to
             enroll in such a study during the first 5 weeks of treatment.

          -  Systemic steroid use for any indication other than peritumoral brain edema.

          -  Use or intended use of dexamethasone as an anti-emetic during Screening or Study

          -  Non-compliance with dexamethasone or anticonvulsant therapy.

          -  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 for 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 infection.

          -  Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for
             women of childbearing potential.

          -  Any conditions that are considered contraindications for patients to receive niacin,
             e.g. liver disease (with LFTs > 3 times the upper limit of the norm),active peptic
             ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.