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

Phase 3

Withdrawn

• Conditions: Brain Edema; Brain Tumor
• Interventions: Drug: hCRF; Drug: placebo hCRF

• Registration Number: NCT00226668
• Lead Sponsor: Celtic Pharma Development Services

Brief 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.

Detailed Description

XERECEPT is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Study Timeline

• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-27
• Study Start: 2006-01
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-27
• Study Completion: 2008-01
• Last Update Posted: 2008-01-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	hCRF	Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
II	placebo hCRF	Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the proportion of responders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2.	Prospective

Trial Locations

Locations (26)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

UC San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Moffitt Cancer Center and Research; 🇺🇸 Tampa, Florida, United States

Winship Cancer Institute, Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern University, Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Evanston Northwestern Healthcare; 🇺🇸 Evanston, Illinois, United States

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