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

Sponsor
Celtic Pharma Development Services (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00226668
Collaborator
Neurobiological Technologies (Industry)
120
Enrollment
26
Locations
2
Arms
24
Duration (Months)
4.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma
Study Start Date :
Jan 1, 2006
Anticipated Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: I

Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking

Drug: hCRF
hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
Other Names:
  • XERECEPT (corticorelin acetate injection)

    		•
    Placebo Comparator: II

    Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking

    Drug: placebo hCRF
    placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
    Other Names:
  • placebo XERECEPT (corticorelin acetate injection)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barrow Neurological Institute Phoenix Arizona United States 85013
    2 UC San Diego Cancer Center La Jolla California United States 92093
    3 Hoag Memorial Hospital Presbyterian Newport Beach California United States 92658
    4 Stanford University Medical Center Palo Alto California United States 94305
    5 UC Davis Medical Center Sacramento California United States 95817
    6 University of Colorado Cancer Center Aurora Colorado United States 80045
    7 Moffitt Cancer Center and Research Tampa Florida United States 33612
    8 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
    9 Northwestern University, Feinberg School of Medicine Chicago Illinois United States 60611
    10 Evanston Northwestern Healthcare Evanston Illinois United States 60201
    11 Beth Israel Deaconess Med Center Boston Massachusetts United States 02215
    12 Field Neurosciences Institute Saginaw Michigan United States 48604
    13 Neurology Group of Bergen County Ridgewood New Jersey United States 07450
    14 Dent Neurologic Institute Amherst New York United States 14226
    15 Weill Medical College of Cornell University New York New York United States 10021
    16 Wake Forest University Winston-Salem North Carolina United States 27106
    17 University Hematology Oncology Care, LLC Cincinnati Ohio United States 43210
    18 Good Samaritan Hospital Cincinnati Ohio United States 45220
    19 The Ohio State University Columbus Ohio United States 43210
    20 Oregon Clinic Portland Oregon United States 97210
    21 Methodist Healthcare - University Hospital Memphis Tennessee United States 38103
    22 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    23 University of Wisconsin Madison Wisconsin United States 53792
    24 Medical College of Wisconsin Milwaukee Wisconsin United States 53226-3596
    25 Cross Cancer Institute Edmonton Alberta Canada T6G1ZT
    26 Ottawa Regional Cancer Centre Ottawa Ontario Canada K1H 1C4

    Sponsors and Collaborators

    • Celtic Pharma Development Services
    • Neurobiological Technologies

    Investigators

    • Principal Investigator: William Shapiro, MD, Barrow Neurological Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00226668
    Other Study ID Numbers:
    • NTI 0302
    • corticorelin acetate injection
    First Posted:
    Sep 27, 2005
    Last Update Posted:
    Jan 3, 2008
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    peritumoral brain edema
    edema
    malignant brain tumor
    astrocytoma
    brain tumor
    dexamethasone
    Decadron
    Additional relevant MeSH terms:
    Brain Neoplasms
    Brain Edema
    Edema
    Corticotropin-Releasing Hormone

    Study Results

    No Results Posted as of Jan 3, 2008