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

Celtic Pharma Development Services

Status and phase

Completed

Phase 3

Conditions

Brain Edema

Brain Tumor

Treatments

Drug: hCRF [XERECEPT (corticorelin acetate injection)]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00226655

NTI 0501

Details and patient eligibility

About

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.

Full description

XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.