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.

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

Condition	Treatment or Intervention	Phase
Brain Edema Brain Tumor	Drug: XERECEPT (corticorelin acetate)	Phase III

Further Study Details: 

Expected Total Enrollment:  200

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 8-24 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 family/friend.
• Life expectancy of at least 4 months at Screening.
• 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. (Alternative anti-emetics such as Compazine, Anzemet, Zofran and Kytril may be considered.)
• 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, in the opinion of the Investigator or the Medical Monitor, would put the patient at unusual risk for study participation. (Patients receiving gastrointestinal prophylactic treatment at Baseline may continue.)
• 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 > 1.5 times of the upper limit of normal), active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.

Arizona
      Barrow Neurological Institute, Phoenix,  Arizona,  85013,  United States; Recruiting
California
      UC San Diego, Thornton Hospital, San Diego,  California,  92037,  United States; Not yet recruiting
      University of Southern California, Los Angeles,  California,  90038,  United States; Not yet recruiting
      Cedars-Sinai Medical Center, Neurosurgical Institute, Los Angeles,  California,  90048,  United States; Not yet recruiting
      UC Davis Medical Center, Division of Medical Oncology, Sacramento,  California,  95817,  United States; Not yet recruiting
Colorado
      Colorado Neurological Institute, Englewood,  Colorado,  80113,  United States; Not yet recruiting
      University of Colorado Cancer Center, Aurora,  Colorado,  80045,  United States; Not yet recruiting
Florida
      Cancer Institute of Orlando, Orlando,  Florida,  32804,  United States; Not yet recruiting
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States; Not yet recruiting
      Moffitt Cancer Center & Research Institute, Tampa,  Florida,  33612-9497,  United States; Not yet recruiting
Georgia
      Winship Cancer Institute, Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Illinois
      Northwestern University, Feinberg School of Medicine, Chicago,  Illinois,  United States; Not yet recruiting
Massachusetts
      Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Not yet recruiting
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Not yet recruiting
New Jersey
      New Jersey Neuroscience Institute, Edison,  New Jersey,  08820,  United States; Not yet recruiting
New York
      Memorial Sloan Kettering Cancer Center, New York,  New York,  10021,  United States; Not yet recruiting
      Dent Neurologic Institute, Amherst,  New York,  14226,  United States; Not yet recruiting
Texas
      The Methodist Hospital, Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Utah
      Huntsman Cancer Institute, University of Utah, Salt Lake City,  Utah,  84112,  United States; Not yet recruiting
Washington
      Virginia Mason Clinic, Seattle,  Washington,  98111,  United States; Not yet recruiting
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G1ZT,  Canada; Not yet recruiting
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Not yet recruiting
Canada, Nova Scotia
      Nova Scotia Cancer Centre, Halifax,  Nova Scotia,  B3H 4K6,  Canada; Not yet recruiting
Canada, Ontario
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada; Not yet recruiting
      Kingston General Hospital, Kingston,  Ontario,  K7L 5P9,  Canada; Not yet recruiting
      Sunnybrook and Women’s College Health, Toronto,  Ontario,  M4N 3M5,  Canada; Not yet recruiting
Canada, Quebec
      Montreal Neurological Institute, Montreal,  Quebec,  H3A 2B4,  Canada; Not yet recruiting
Canada, Saskatchewan
      Regina General Hospital, Regina,  Saskatchewan,  S4P 0W5,  Canada; Not yet recruiting

Study ID Numbers:  NTI 0303; XERECEPT™; corticorelin acetate
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  July 20, 2004
ClinicalTrials.gov Identifier:  NCT00088166
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08