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

NCT ID: NCT00226655

Last Updated: 2012-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-04-30

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.

Conditions

Brain Edema; Brain Tumor

Keywords

peritumoral brain edema; edema; malignant brain tumor; astrocytoma; brain tumor; dexamethasone; Decadron

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I

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

Group Type: EXPERIMENTAL

hCRF [XERECEPT (corticorelin acetate injection)]

Intervention Type: DRUG

2mg/day

Interventions

hCRF [XERECEPT (corticorelin acetate injection)]

2mg/day

Intervention Type: DRUG

Other Intervention Names

hCRF, XERECEPT (corticorelin acetate injection)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurobiological Technologies

INDUSTRY

Sponsor Role: collaborator

Celtic Pharma Development Services

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurological Institute

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford University Medical Center

Palo Alto, California, United States

UC Davis Medical Center, Division of Medical Oncology

Sacramento, California, United States

UC San Diego Cancer Center

San Diego, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Colorado Neurological Institute Center for Brain & Spinal Tumors

Englewood, Colorado, United States

Mayo Clinic

Jacksonville, Florida, United States

Cancer Institute of Orlando

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Feinberg School of Medicine, Northwestern University

Chicago, Illinois, United States

Evanston Northwestern Healthcare

Evanston, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Hermelin Brain Tumor Center, Henry Ford Hospital

Detroit, Michigan, United States

Dent Neurologic Institute

Amherst, New York, 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

University Hematology Oncology Care, LLC

Cincinnati, Ohio, United States

Good Samaritan Hospital

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Clinic

Portland, Oregon, United States

Virginia Mason Clinic

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Caner Centre of Southwestern Ontario/ Kingston General Hospital

Kingston, Ontario, Canada

Ottawa Regional Cancer Center

Ottawa, Ontario, Canada

Sunnybrook and Women's College Health Sciences Center

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

NTI 0501

Identifier Type: -

Identifier Source: org_study_id