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

This study has been completed.
Sponsor:
Collaborator:
Neurobiological Technologies
Information provided by (Responsible Party):
Celtic Pharma Development Services
ClinicalTrials.gov Identifier:
NCT00226655
First received: September 23, 2005
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Brain Edema
Brain Tumor
Drug: hCRF [XERECEPT (corticorelin acetate injection)]
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Celtic Pharma Development Services:

Primary Outcome Measures:
  • Long Term Safety and Tolerability of hCRF [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
    Number of patients reporting adverse events


Enrollment: 112
Study Start Date: July 2005
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
All patients will receive hCRF (XERECEPT) 2mg/day
Drug: hCRF [XERECEPT (corticorelin acetate injection)]
2mg/day
Other Name: hCRF, XERECEPT (corticorelin acetate injection)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226655

  Show 32 Study Locations
Sponsors and Collaborators
Celtic Pharma Development Services
Neurobiological Technologies
Investigators
Principal Investigator: William Shapiro, MD Barrow Neurological Institute
  More Information

No publications provided

Responsible Party: Celtic Pharma Development Services
ClinicalTrials.gov Identifier: NCT00226655     History of Changes
Other Study ID Numbers: NTI 0501
Study First Received: September 23, 2005
Results First Received: July 31, 2012
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celtic Pharma Development Services:
peritumoral brain edema
edema
malignant brain tumor
astrocytoma
brain tumor
dexamethasone
Decadron

Additional relevant MeSH terms:
Brain Edema
Brain Neoplasms
Edema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Signs and Symptoms
Corticotropin-Releasing Hormone
Dexamethasone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 21, 2014