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

An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Brain Edema
• Intervention / Treatment: Drug: hCRF [XERECEPT (corticorelin acetate injection)]

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 (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1ZT
      • Cross Cancer Institute
  • Manitoba
    • Winnipeg, Manitoba, Canada, MB R3E 0V9
      • CancerCare Manitoba
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • The Moncton Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Queen Elizabeth II Health Sciences Center
  • Ontario
    • Kingston, Ontario, Canada, K7L 5P9
      • Caner Centre of Southwestern Ontario/ Kingston General Hospital
    • Ottawa, Ontario, Canada, K1H 1C4
      • Ottawa Regional Cancer Center
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook and Women's College Health Sciences Center
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • 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, Division of Medical Oncology
    • San Diego, California, United States, 92037
      • UC San Diego Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute Center for Brain & Spinal Tumors
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Orlando, Florida, United States, 32804
      • Cancer Institute of Orlando
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Feinberg School of Medicine, Northwestern University
    • Evanston, Illinois, United States, 60201
      • Evanston Northwestern Healthcare
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Hermelin Brain Tumor Center, Henry Ford Hospital
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10021
      • Weill Medical College of Cornell 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
  • Washington
    • Seattle, Washington, United States, 98111
      • Virginia Mason Clinic
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3596
      • Medical College of Wisconsin

Participation Criteria

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:

• 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 availability of assistance from caregiver.
• Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
• For women of childbearing potential: a negative serum pregnancy test at Baseline

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 endocrine metabolic disease which could put the patient at unusual risk during study participation.
• Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
• Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)
• Central nervous system (CNS) infection.
• Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: I; All patients will receive hCRF (XERECEPT) 2mg/day	Drug: hCRF [XERECEPT (corticorelin acetate injection)]; 2mg/day; Other Names: hCRF, XERECEPT (corticorelin acetate injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Safety and Tolerability of hCRF	Number of patients reporting adverse events	Prospective

Collaborators and Investigators

• Sponsor: Celtic Pharma Development Services
• Collaborators: Neurobiological Technologies

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): April 1, 2009

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): August 31, 2012
• Last Update Submitted That Met QC Criteria: July 31, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: edema; brain tumor; dexamethasone; Decadron; malignant brain tumor; astrocytoma; peritumoral brain edema
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Brain Edema; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Corticotropin-Releasing Hormone
• Other Study ID Numbers: NTI 0501