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

December 27, 2007 updated by: Celtic Pharma Development Services

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Prospective
Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celtic Pharma Development Services

Collaborators

Neurobiological Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (ANTICIPATED)

January 1, 2008

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (ESTIMATE)

September 27, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 3, 2008

Last Update Submitted That Met QC Criteria

December 27, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTI 0302
  • corticorelin acetate injection

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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