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XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226668
Recruitment Status : Withdrawn (Alternate study projected to assess imaging endpoints versus clinical endpoints.)
First Posted : September 27, 2005
Last Update Posted : January 3, 2008
Neurobiological Technologies
Information provided by:
Celtic Pharma Development Services

Brief Summary:
The purpose of this study is to examine the safety and efficacy of XERECEPT (human Corticotropin-Releasing Factor, or hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.

Condition or disease Intervention/treatment Phase
Brain Edema Brain Tumor Drug: hCRF Drug: placebo hCRF Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-Blind Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Dexamethasone for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Primary Malignant Glioma
Study Start Date : January 2006
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: I
Patients will receive hCRf (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone that they may be taking
Drug: hCRF
hCRF 2mg/day; dexamethasone 4mg/day along with any open-label dexamethasone they may be taking
Other Name: XERECEPT (corticorelin acetate injection)

Placebo Comparator: II
Patients will receive placebo hCRF (XERECEPT) 2mg/day and dexamethasone 4 mg/day along with any open-label dexamethasone they may be taking
Drug: placebo hCRF
placebo hCRF 2mg/day, dexamethasone 4mg/day and any open-label dexamethasone they may be taking
Other Name: placebo XERECEPT (corticorelin acetate injection)

Primary Outcome Measures :
  1. The primary efficacy endpoint is the proportion of responders, i.e. patients in each treatment group who show improvement at the end of Week 1 and continue to be classified as improved relative to Baseline at Week 2. [ Time Frame: Prospective ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed diagnosis of a primary malignant glioma.
  • Symptomatic peritumoral brain edema requiring initiation or increase of dexamethasone treatment.
  • If a patient is on dexamethasone for treatment of symptomatic peritumoral brain edema, the dose must be stable and should not exceed 24mg/dl for a minimum of 7 days prior to Baseline.
  • Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline.
  • Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.

Exclusion Criteria:

  • Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
  • Systemic steroid use for any other indication than peritumoral brain edema.
  • Patients on dexamethasone or anticonvulsant therapy.
  • Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk for study participation.
  • Central nervous system (CNS) infection.
  • Conditions that are considered contradictions for patients to receive niacin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226668

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Sponsors and Collaborators
Celtic Pharma Development Services
Neurobiological Technologies
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Principal Investigator: William Shapiro, MD Barrow Neurological Institute
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Responsible Party: Patrick Rossi, MD - Medical Monitor, Celtic Pharma Development Services Identifier: NCT00226668    
Other Study ID Numbers: NTI 0302
corticorelin acetate injection
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: January 3, 2008
Last Verified: December 2007
Keywords provided by Celtic Pharma Development Services:
peritumoral brain edema
malignant brain tumor
brain tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Brain Edema
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Corticotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs