Clinical trial NCT00088166 (phase 3, status: completed)
Conditions: brain edema, brain tumor
ICD codes: C71.7, C71.9, C79.31, D33.0, D33.1, D33.2, D49.6
Drugs: hcrf, placebo hcrf
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.