©2022 Stanford Medicine
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
Not Recruiting
Trial ID: NCT00088166
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
Stanford Investigator(s)
Lawrence Recht, MD
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
Paul Graham Fisher, MD
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Laurence Katznelson, MD
Professor of Neurosurgery and of Medicine (Endocrinology)
Eligibility
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.
Intervention(s):
drug: hCRF
drug: placebo hCRF
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lynn Adler
6507258630