An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

Last updated: July 31, 2012
Sponsor: Celtic Pharma Development Services
Overall Status: Completed

Phase

3

Condition

Brain Tumor

Gliomas

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00226655
NTI 0501
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.

  • Have a Karnofsky Performance of > 50 at Baseline

  • Capable of self-administration of subcutaneous injections twice daily or availabilityof assistance from caregiver.

  • Ability to provide written informed consent or, if unable to provide, have a legalguardian or representative provide written informed consent.

  • For women of childbearing potential: a negative serum pregnancy test at Baseline

Exclusion

Exclusion Criteria:

  • Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.

  • Systemic steroid use for any indication other than peritumoral brain edema.

  • Use or intended use of dexamethasone as an anti-emetic during study.

  • Clinical signs and symptoms of cerebral herniation.

  • Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrinemetabolic disease which could put the patient at unusual risk during studyparticipation.

  • Confounding previous or concurrent neurological disorders that would interfere withadequate clinical evaluation.

  • Clinically significant head injury or chronic seizure disorder, if the conditionresults in functional impairment or is likely to interfere withevaluations.(Maintenance anticonvulsant therapy is allowed)

  • Central nervous system (CNS) infection.

  • Pregnancy, breastfeeding and/or refusal to practice birth control while in study, forwomen of childbearing potential.

Study Design

Total Participants: 112
Study Start date:
July 01, 2005
Estimated Completion Date:
April 30, 2009

Study Description

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

Connect with a study center

  • Cross Cancer Institute

    Edmonton, Alberta T6G1ZT
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba MB R3E 0V9
    Canada

    Site Not Available

  • The Moncton Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Caner Centre of Southwestern Ontario/ Kingston General Hospital

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • Ottawa Regional Cancer Center

    Ottawa, Ontario K1H 1C4
    Canada

    Site Not Available

  • Sunnybrook and Women's College Health Sciences Center

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92658
    United States

    Site Not Available

  • Stanford University Medical Center

    Palo Alto, California 94305
    United States

    Site Not Available

  • UC Davis Medical Center, Division of Medical Oncology

    Sacramento, California 95817
    United States

    Site Not Available

  • UC San Diego Cancer Center

    San Diego, California 92037
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Colorado Neurological Institute Center for Brain & Spinal Tumors

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Cancer Institute of Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Feinberg School of Medicine, Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Evanston Northwestern Healthcare

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Hermelin Brain Tumor Center, Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Dent Neurologic Institute

    Amherst, New York 14226
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Weill Medical College of Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • Good Samaritan Hospital

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • University Hematology Oncology Care, LLC

    Cincinnati, Ohio 43210
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Clinic

    Portland, Oregon 97210
    United States

    Site Not Available

  • Virginia Mason Clinic

    Seattle, Washington 98111
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226-3596
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.