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

NCT00226655 | Completed Phase 3 Results DMC

• 1 other identifier: NTI 0501
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 32

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.

Conditions

Brain Edema; Brain Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Long Term Safety and Tolerability of hCRF

  Number of patients reporting adverse events

  Prospective

Study Arms (1)

I

EXPERIMENTAL

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

Drug: hCRF [XERECEPT (corticorelin acetate injection)]

Interventions

hCRF [XERECEPT (corticorelin acetate injection)] DRUG

2mg/day

Also known as: hCRF, XERECEPT (corticorelin acetate injection)

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celtic Pharma Development Services: lead
• Neurobiological Technologies: collaborator

Study Sites (32)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

UC Davis Medical Center, Division of Medical Oncology

Sacramento, California, 95817, United States

Location

UC San Diego Cancer Center

San Diego, California, 92037, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Colorado Neurological Institute Center for Brain & Spinal Tumors

Englewood, Colorado, 80113, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Cancer Institute of Orlando

Orlando, Florida, 32804, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Feinberg School of Medicine, Northwestern University

Chicago, Illinois, 60611, United States

Location

Evanston Northwestern Healthcare

Evanston, Illinois, 60201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hermelin Brain Tumor Center, Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

University Hematology Oncology Care, LLC

Cincinnati, Ohio, 43210, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Clinic

Portland, Oregon, 97210, United States

Location

Virginia Mason Clinic

Seattle, Washington, 98111, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3596, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G1ZT, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, MB R3E 0V9, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Caner Centre of Southwestern Ontario/ Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

Ottawa Regional Cancer Center

Ottawa, Ontario, K1H 1C4, Canada

Location

Sunnybrook and Women's College Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Brain Edema; Brain Neoplasms; Edema; Astrocytoma

Interventions

Corticotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Director Medical Sciences
• Organization: Celtic Pharma Development Services America Inc

henk-andre.kroon@dev.celticpharma.com

(212) 616 4016

Study Officials

• William Shapiro, MD

  Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: July 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: August 31, 2012
• Results First Posted: August 31, 2012

Record last verified: 2012-07

Locations

US (25); CA (7)