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

• Status: Withdrawn
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celtic Pharma Development Services
• Collaborator: Neurobiological Technologies
• Treatments: BB 1101; Corticotropin-Releasing Hormone; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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