Clinical trial NCT00226655: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Edema
Brain Tumor
Keywords: peritumoral brain edema
edema
malignant brain tumor
astrocytoma
brain tumor
dexamethasone
Decadron
Lead sponsor: Celtic Pharma Development Services
Sponsor class: INDUSTRY
Collaborators: name: Neurobiological Technologies
First posted: 2005-09-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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