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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


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

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Trial Information

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


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:



- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

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 0302

NCT ID:

NCT00226668

Start Date:

January 2006

Completion Date:

January 2008

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

Wake Forest UniversityWinston-Salem, North Carolina  27103
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Medical College of WisconsinMilwaukee, Wisconsin  53226
Weill Medical College of Cornell UniversityNew York, New York  10021
Good Samaritan HospitalDayton, Ohio  45406
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Evanston Northwestern HealthcareEvanston, Illinois  60201
The Ohio State UniversityColumbus, Ohio  43210
Barrow Neurological InstitutePhoenix, Arizona  85013
Northwestern University, Feinberg School of MedicineChicago, Illinois  60611
University of WisconsinMadison,, Wisconsin  53792-5666
Dent Neurologic InstituteAmherst, New York  14226
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Neurology Group of Bergen CountyRidgewood, New Jersey  07450
University Hematology Oncology Care, LLCCincinnati, Ohio  43210
Oregon ClinicPortland, Oregon  97210
UC Davis Medical CenterSacramento, California  95817
UC San Diego Cancer CenterSan Diego, California  92037
Moffitt Cancer Center and ResearchTampa, Florida  33612
Beth Israel Deaconess Med CenterBoston, Massachusetts  02215
Field Neurosciences InstituteSaginaw, Michigan  48604
Methodist Healthcare - University HospitalMemphis, Tennessee  38103