XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
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: 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 Exclusion Criteria: 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.
Sites / Locations
- Barrow Neurological Institute
- UCSF Fresno Center for Clinical Studies
- Hoag Memorial Hospital Presbyterian
- Stanford University Medical Center
- UC Davis Medical Center, Division of Medical Oncology
- UC San Diego, Thornton Hospital
- University of Colorado Cancer Center
- Colorado Neurological Institute
- Mayo Clinic
- Cancer Institute of Orlando
- Moffitt Cancer Center & Research Institute
- Winship Cancer Institute, Emory University
- Northwestern University, Feinberg School of Medicine
- Evanston Northwestern Healthcare
- Beth Israel Deaconess Medical Center
- Hermelin Brain Tumor Center, Henry Ford Hospital
- Neurology Group of Bergen County
- 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
- Kingston General Hospital
- Ottawa Regional Cancer Centre
- Sunnybrook and Women's College Health
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
I
II
Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking