XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
Trial ID or NCT#
NCT00088166
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Lawrence Recht, MD
Neuro-oncologist
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
Paul Graham Fisher, MD
Neuro-oncologist,
Pediatric neurologist
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Laurence Katznelson, MD
Contact us to find out if this trial is right for you.
Contact
Lynn Adler
6507258630
View on ClinicalTrials.gov
