XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

Completed · Phase 3 · Has a placebo group

Conditions studied: Brain Edema, Brain Tumor

In brief

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.

Key facts

Study ID

NCT00088166

Run by

Celtic Pharma Development Services

People needed

200

Starts

2004-05-01

Expected to finish

2008-03-01

Last updated by the study team

2014-08-13

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• UCSF Fresno Center for Clinical Studies — Fresno, 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, Division of Medical Oncology — Sacramento, California, United States
• UC San Diego, Thornton Hospital — San Diego, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Cancer Institute of Orlando — Orlando, Florida, United States
• Moffitt Cancer Center & Research Institute — 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 Medical Center — Boston, Massachusetts, United States
• Hermelin Brain Tumor Center, Henry Ford Hospital — Detroit, Michigan, United States
• Neurology Group of Bergen County — Ridgewood, New Jersey, United States
• Dent Neurologic Institute — Amherst, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, 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
• Virginia Mason Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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