XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

NCT00226668 | Withdrawn Phase 3 DMC

• 2 other identifiers: NTI 0302corticorelin acetate injection
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 26

Brief Summary

The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

Conditions

Brain Edema; Brain Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the proportion of responders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2.

  Prospective

Study Arms (2)

I

EXPERIMENTAL

Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking

Drug: hCRF

II

PLACEBO COMPARATOR

Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking

Drug: placebo hCRF

Interventions

hCRF DRUG

hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking

Also known as: XERECEPT (corticorelin acetate injection)

I

placebo hCRF DRUG

placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking

Also known as: placebo XERECEPT (corticorelin acetate injection)

II

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of a primary malignant glioma.
• Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
• If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
• Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
• Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.

You may not qualify if:

• Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
• Systemic steroid use for any other indication than peritumoral brain edema.
• Patients on dexamethasone or anticonvulsant therapy.
• Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
• Central nervous system (CNS) infection.
• Conditions that are considered contradictions for patients to receive niacin

Sponsors & Collaborators

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

Study Sites (26)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

UC San Diego Cancer Center

La Jolla, California, 92093, 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

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Moffitt Cancer Center and Research

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Evanston Northwestern Healthcare

Evanston, Illinois, 60201, United States

Location

Beth Israel Deaconess Med Center

Boston, Massachusetts, 02215, United States

Location

Field Neurosciences Institute

Saginaw, Michigan, 48604, United States

Location

Neurology Group of Bergen County

Ridgewood, New Jersey, 07450, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27106, 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

Methodist Healthcare - University Hospital

Memphis, Tennessee, 38103, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, 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

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, 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

Study Officials

• William Shapiro, MD

  Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: January 1, 2006
• Study Completion: January 1, 2008
• Last Updated: January 3, 2008

Record last verified: 2007-12

Locations

US (24); CA (2)