An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
Brain Edema, Brain Tumor
About this trial
This is an interventional treatment trial for Brain Edema focused on measuring peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Barrow Neurological Institute
- Hoag Memorial Hospital Presbyterian
- Stanford University Medical Center
- UC Davis Medical Center, Division of Medical Oncology
- UC San Diego Cancer Center
- University of Colorado Cancer Center
- Colorado Neurological Institute Center for Brain & Spinal Tumors
- Mayo Clinic
- Cancer Institute of Orlando
- Moffitt Cancer Center
- Winship Cancer Institute, Emory University
- Feinberg School of Medicine, Northwestern University
- Evanston Northwestern Healthcare
- Beth Israel Deaconess Medical Center
- Hermelin Brain Tumor Center, Henry Ford Hospital
- Dent Neurologic Institute
- Memorial Sloan Kettering Cancer Center
- Weill Medical College of Cornell University
- University Hematology Oncology Care, LLC
- Good Samaritan Hospital
- The Ohio State University
- Oregon Clinic
- Virginia Mason Clinic
- University of Wisconsin
- Medical College of Wisconsin
- Cross Cancer Institute
- CancerCare Manitoba
- The Moncton Hospital
- Queen Elizabeth II Health Sciences Center
- Caner Centre of Southwestern Ontario/ Kingston General Hospital
- Ottawa Regional Cancer Center
- Sunnybrook and Women's College Health Sciences Center
Arms of the Study
Arm 1
Experimental
I
All patients will receive hCRF (XERECEPT) 2mg/day