Trial Search Results

XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Celtic Pharma Development Services

Collaborator: Neurobiological Technologies

Intervention(s):

  • Drug: hCRF
  • Drug: placebo hCRF

Phase:

Phase 3

Eligibility


Inclusion 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.

Exclusion Criteria:

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cathy Recht
6507258630
Not Recruiting