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

Phase 3

Completed

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
I	hCRF [XERECEPT (corticorelin acetate injection)]	All patients will receive hCRF (XERECEPT) 2mg/day

Primary Outcome Measures

Name	Time	Method
Long Term Safety and Tolerability of hCRF	Prospective	Number of patients reporting adverse events

Secondary Outcome Measures

Name	Time	Method

Locations (32): 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
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Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States