XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
Trial ID or NCT#
Status
Purpose
The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.
Official Title
A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma
Eligibility Criteria
- - Histologically confirmed diagnosis of a primary malignant glioma. - Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment. - If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline. - Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline. - Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.
- - Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment. - Systemic steroid use for any other indication than peritumoral brain edema. - Patients on dexamethasone or anticonvulsant therapy. - Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation. - Central nervous system (CNS) infection. - Conditions that are considered contradictions for patients to receive niacin
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Cathy Recht
6507258630
View on ClinicalTrials.gov