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A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone


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

Thank you

Trial Information

A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone


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 brain tumor or, if
metastatic, documentation and histology (if available) of primary source of cancer.

- Patient must have 1 or more qualifying steroid-associated side effect(s) at Baseline.

- Patient has required administration of dexamethasone to control symptoms of
peritumoral edema for at least 30 days.

- Stable dexamethasone dose of 4-24 mg/day for at least 14 days prior to Baseline.

- Need for administration of dexamethasone to treat peritumoral brain edema (referenced
above) has been documented by MRI or comparable diagnostic technology within 21 days
of Baseline.

- Karnofsky score of > 50 at Screening and Baseline.

- Capable of self-administration of subcutaneous injections twice daily for 12 weeks,
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 Screening.

- Must be 18 years of age or older

Exclusion Criteria:

- Ongoing or anticipated need for surgery, radiosurgery or radiation therapy or the
introduction of new chemotherapeutic regime within the first 5 weeks of study
enrollment. Treatment with pre-study chemotherapy may continue.

- Concurrent enrollment in any other investigational drug or device study, or plan to
enroll in such a study during the first 5 weeks of treatment.

- Systemic steroid use for any indication other than peritumoral brain edema.

- Use or intended use of dexamethasone as an anti-emetic during Screening or Study

- Non-compliance with dexamethasone or anticonvulsant therapy.

- 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 for 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 infection.

- Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for
women of childbearing potential.

- Any conditions that are considered contraindications for patients to receive niacin,
e.g. liver disease (with LFTs > 3 times the upper limit of the norm),active peptic
ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The proportion of patients in each treatment group who are Responders at Week 2 and continue at Week 5

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 0303

NCT ID:

NCT00088166

Start Date:

May 2004

Completion Date:

March 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

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
Northwestern University, Feinberg School of MedicineChicago, Illinois  60611
University of WisconsinMadison,, Wisconsin  53792-5666
Dent Neurologic InstituteAmherst, New York  14226
UCSF Fresno Center for Clinical StudiesFresno, California  93702
UC Davis Medical Center, Division of Medical OncologySacramento, California  95817
UC San Diego, Thornton HospitalSan Diego, California  92037
Colorado Neurological InstituteEnglewood, Colorado  80113
Cancer Institute of OrlandoOrlando, Florida  32804
Moffitt Cancer Center & Research InstituteTampa, Florida  33612-9497
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Hermelin Brain Tumor Center, Henry Ford HospitalDetroit, Michigan  48202
Neurology Group of Bergen CountyRidgewood, New Jersey  07450
University Hematology Oncology Care, LLCCincinnati, Ohio  43210
Oregon ClinicPortland, Oregon  97210
Virginia Mason ClinicSeattle, Washington  98111