XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

Not Recruiting

Trial ID: NCT00088166


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
Lawrence Recht, MD

Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Paul Graham Fisher, MD
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


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.


drug: hCRF

drug: placebo hCRF

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lynn Adler

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