An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

Completed · Phase 3

Conditions studied: Brain Edema, Brain Tumor

In brief

The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

Key facts

Study ID

NCT00226655

Run by

Celtic Pharma Development Services

People needed

112

Starts

2005-07-01

Expected to finish

2009-04-01

Last updated by the study team

2012-08-31

Who can join

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

You may qualify if…

• Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
• Have a Karnofsky Performance of > 50 at Baseline
• Capable of self-administration of subcutaneous injections twice daily 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 Baseline

You may not qualify if…

• Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
• Systemic steroid use for any indication other than peritumoral brain edema.
• Use or intended use of dexamethasone as an anti-emetic during study.
• 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 during 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.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, 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 Cancer Center — San Diego, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Colorado Neurological Institute Center for Brain & Spinal Tumors — Englewood, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Cancer Institute of Orlando — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Feinberg School of Medicine, Northwestern University — 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
• 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
• University of Wisconsin — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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