XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Brain Edema, Brain Tumor

In brief

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

Key facts

Study ID

NCT00226668

Run by

Celtic Pharma Development Services

People needed

120

Starts

2006-01-01

Expected to finish

2008-01-01

Last updated by the study team

2008-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of a primary malignant glioma.
• 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.
• Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.

You may not qualify if…

• Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
• Systemic steroid use for any other indication than peritumoral brain edema.
• Patients on dexamethasone or anticonvulsant therapy.
• Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
• Central nervous system (CNS) infection.
• Conditions that are considered contradictions for patients to receive niacin

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• UC San Diego Cancer Center — La Jolla, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Moffitt Cancer Center and Research — Tampa, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Northwestern University, Feinberg School of Medicine — Chicago, Illinois, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Beth Israel Deaconess Med Center — Boston, Massachusetts, United States
• Field Neurosciences Institute — Saginaw, Michigan, United States
• Neurology Group of Bergen County — Ridgewood, New Jersey, United States
• Dent Neurologic Institute — Amherst, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• University Hematology Oncology Care, LLC — Cincinnati, Ohio, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Oregon Clinic — Portland, Oregon, United States
• Methodist Healthcare - University Hospital — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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