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

Primary Purpose

Brain Edema, Brain Tumor

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
hCRF [XERECEPT (corticorelin acetate injection)]
Sponsored by
Celtic Pharma Development Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Edema focused on measuring peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barrow Neurological Institute
  • Hoag Memorial Hospital Presbyterian
  • Stanford University Medical Center
  • UC Davis Medical Center, Division of Medical Oncology
  • UC San Diego Cancer Center
  • University of Colorado Cancer Center
  • Colorado Neurological Institute Center for Brain & Spinal Tumors
  • Mayo Clinic
  • Cancer Institute of Orlando
  • Moffitt Cancer Center
  • Winship Cancer Institute, Emory University
  • Feinberg School of Medicine, Northwestern University
  • Evanston Northwestern Healthcare
  • Beth Israel Deaconess Medical Center
  • Hermelin Brain Tumor Center, Henry Ford Hospital
  • Dent Neurologic Institute
  • Memorial Sloan Kettering Cancer Center
  • Weill Medical College of Cornell University
  • University Hematology Oncology Care, LLC
  • Good Samaritan Hospital
  • The Ohio State University
  • Oregon Clinic
  • Virginia Mason Clinic
  • University of Wisconsin
  • Medical College of Wisconsin
  • Cross Cancer Institute
  • CancerCare Manitoba
  • The Moncton Hospital
  • Queen Elizabeth II Health Sciences Center
  • Caner Centre of Southwestern Ontario/ Kingston General Hospital
  • Ottawa Regional Cancer Center
  • Sunnybrook and Women's College Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

All patients will receive hCRF (XERECEPT) 2mg/day

Outcomes

Primary Outcome Measures

Long Term Safety and Tolerability of hCRF
Number of patients reporting adverse events

Secondary Outcome Measures

Full Information

First Posted
September 23, 2005
Last Updated
July 31, 2012
Sponsor
Celtic Pharma Development Services
Collaborators
Neurobiological Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT00226655
Brief Title
An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celtic Pharma Development Services
Collaborators
Neurobiological Technologies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Edema, Brain Tumor
Keywords
peritumoral brain edema, edema, malignant brain tumor, astrocytoma, brain tumor, dexamethasone, Decadron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
All patients will receive hCRF (XERECEPT) 2mg/day
Intervention Type
Drug
Intervention Name(s)
hCRF [XERECEPT (corticorelin acetate injection)]
Other Intervention Name(s)
hCRF, XERECEPT (corticorelin acetate injection)
Intervention Description
2mg/day
Primary Outcome Measure Information:
Title
Long Term Safety and Tolerability of hCRF
Description
Number of patients reporting adverse events
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Shapiro, MD
Organizational Affiliation
Barrow Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
UC Davis Medical Center, Division of Medical Oncology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UC San Diego Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Neurological Institute Center for Brain & Spinal Tumors
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cancer Institute of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Feinberg School of Medicine, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hermelin Brain Tumor Center, Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University Hematology Oncology Care, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Virginia Mason Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1ZT
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
MB R3E 0V9
Country
Canada
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Caner Centre of Southwestern Ontario/ Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Ottawa Regional Cancer Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Sunnybrook and Women's College Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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