Overview

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Withdrawn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