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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Brain Edema, Brain Tumor

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Long Term Safety and Tolerability of hCRF

Outcome Description:

Number of patients reporting adverse events

Outcome Time Frame:

Prospective

Safety Issue:

Yes

Principal Investigator

William Shapiro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barrow Neurological Institute

Authority:

United States: Food and Drug Administration

Study ID:

NTI 0501

NCT ID:

NCT00226655

Start Date:

July 2005

Completion Date:

April 2009

Related Keywords:

  • Brain Edema
  • Brain Tumor
  • peritumoral brain edema
  • edema
  • malignant brain tumor
  • astrocytoma
  • brain tumor
  • dexamethasone
  • Decadron
  • Brain Edema
  • Brain Neoplasms
  • Edema

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Medical College of WisconsinMilwaukee, Wisconsin  53226
Weill Medical College of Cornell UniversityNew York, New York  10021
Mayo ClinicJacksonville, Florida  32224
Good Samaritan HospitalDayton, Ohio  45406
Evanston Northwestern HealthcareEvanston, Illinois  60201
The Ohio State UniversityColumbus, Ohio  43210
Barrow Neurological InstitutePhoenix, Arizona  85013
Moffitt Cancer CenterTampa, Florida  33612
University of WisconsinMadison,, Wisconsin  53792-5666
Dent Neurologic InstituteAmherst, New York  14226
UC Davis Medical Center, Division of Medical OncologySacramento, California  95817
Cancer Institute of OrlandoOrlando, Florida  32804
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Hermelin Brain Tumor Center, Henry Ford HospitalDetroit, Michigan  48202
University Hematology Oncology Care, LLCCincinnati, Ohio  43210
Oregon ClinicPortland, Oregon  97210
Virginia Mason ClinicSeattle, Washington  98111
UC San Diego Cancer CenterSan Diego, California  92037
Colorado Neurological Institute Center for Brain & Spinal TumorsEnglewood, Colorado  80113
Feinberg School of Medicine, Northwestern UniversityChicago, Illinois  60611