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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
Not Enrolling
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

- 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:


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:


Safety Issue:


Principal Investigator

William Shapiro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barrow Neurological Institute


United States: Food and Drug Administration

Study ID:

NTI 0501



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



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