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

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226655
• Other study ID #: NTI 0501
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2005
• Last updated: July 31, 2012
• Start date: July 2005
• Est. completion date: April 2009

Study information

• Verified date: July 2012
• Source: Celtic Pharma Development Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Edema
• Brain Neoplasms
• Brain Tumor

Intervention

Drug:
• hCRF [XERECEPT (corticorelin acetate injection)]
2mg/day

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	Caner Centre of Southwestern Ontario/ Kingston General Hospital	Kingston	Ontario
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Ottawa Regional Cancer Center	Ottawa	Ontario
Canada	Sunnybrook and Women's College Health Sciences Center	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	Dent Neurologic Institute	Amherst	New York
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Feinberg School of Medicine, Northwestern University	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	University Hematology Oncology Care, LLC	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Hermelin Brain Tumor Center, Henry Ford Hospital	Detroit	Michigan
United States	Colorado Neurological Institute Center for Brain & Spinal Tumors	Englewood	Colorado
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Wisconsin	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Cancer Institute of Orlando	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Oregon Clinic	Portland	Oregon
United States	UC Davis Medical Center, Division of Medical Oncology	Sacramento	California
United States	UC San Diego Cancer Center	San Diego	California
United States	Virginia Mason Clinic	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Celtic Pharma Development Services	Neurobiological Technologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long Term Safety and Tolerability of hCRF	Number of patients reporting adverse events	Prospective	Yes