The purpose of this study is to examine the safety and efficacy of human Corticotropin-Releasing Factor (hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

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

Further Study Details: 

Primary Outcomes: The primary efficacy endpoint is the proportion of reponders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2. Improvement is defined as:; -Lower overall score on the 10-item Neurological Exam of at least 25% relative to Baseline, and; -Karnofsky Performance Score unchanged or increased relative to Baseline, and; -No post-Baseline increase in dexamethasone dose on more than 1 day, with a maximum allowable increase of less than 4mg on that day.
Expected Total Enrollment:  120

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

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

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of a primary malignant glioma.
• 10-item Neurological Exam confirms at least a 3-point total brain tumor related score at Baseline.
• Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
• If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
• Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
• Karnofsky Performance of greater than or equal to 50 to greater than or equal to 90 at Screening and Baseline.
• Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.
• Life expectancy of at least 3 months at Screening.
• Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
• Women of childbearing potential must have a negative serum pregnancy test at Screening.
• Must be 18 years of age or older.

Exclusion Criteria:

• Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
• Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 2 weeks of treatment.
• Systemic steroid use for any other indication 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)
• Patients on 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.
• 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.
• Conditions that are considered contradictions for patinets to receive niacin, e.g. liver disase with LFTs greater than or equal to 3.0 times the upper limit of the norm, active peptic ulcer, arterial hemorrhage, asthma and knwn hypersensitivity to niacin.

Please refer to this study by ClinicalTrials.gov identifier  NCT00226668

Lisa U. Carr, MD, PhD      510-595-6000 

Arizona
      Barrow Neurological Institute, Phoenix,  Arizona,  85013,  United States
California
      UC San Diego Cancer Center, San Diego,  California,  92093,  United States
      Stanford University Medical Center, Palo Alto,  California,  94305,  United States
      UC Davis Medical Center, Sacramento,  California,  95817,  United States
      UCSF- Fresno MEP Center for Clinical Studies, Fresno,  California,  93703,  United States
Colorado
      Colorado Neurological Institute Center for Brain & Spinal Tumors, Englewood,  Colorado,  80113,  United States
Florida
      Cancer Institute of Orlando, Orlando,  Florida,  32804,  United States
      Moffitt Cancer Center and Research, Tampa,  Florida,  33612,  United States
Georgia
      Winship Cancer Institute, Emory University, Atlanta,  Georgia,  30322,  United States
Illinois
      Northwestern University, Feinberg School of Medicine, Chicago,  Illinois,  60611,  United States
Kentucky
      University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536,  United States
Massachusetts
      Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Beth Isreal Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Michigan
      Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
New Jersey
      New Jersey Neuroscience Institute, Edison,  New Jersey,  08820,  United States
New York
      Dent Neurologic Institute, Amherst,  New York,  14226,  United States
      Memorial Sloan Kettering Cancer Center, New York,  New York,  10021,  United States
North Carolina
      Wake Forest University, Winston Salem,  North Carolina,  27106,  United States
Ohio
      The Ohio State University, Columbus,  Ohio,  43210,  United States
Pennsylvania
      Bodine Center for Cancer Treatment, Philadelphia,  Pennsylvania,  19107,  United States
Tennessee
      Methodist Healthcare - University Hospital, Memphis,  Tennessee,  38103,  United States
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States
Utah
      Hunstman Cancer Institute - University of Utah, Salt Lake City,  Utah,  98111,  United States
Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53792,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G1ZT,  Canada
Canada, Ontario
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada
Canada, Saskatchewan
      Regina General Hospital, Regina,  Saskatchewan,  S4P 0W5,  Canada

Study chairs or principal investigators

William Shapiro, MD,  Principal Investigator,  Barrow Neurological Institute   

Study ID Numbers:  NTI-0302
Last Updated:  September 26, 2005
Record first received:  September 23, 2005
ClinicalTrials.gov Identifier:  NCT00226668
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27