Clinical Trial: hCRF for Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema Associated with Primary Malignant Glioma

This study is not yet open for patient recruitment.
Verified by Neurobiological Technologies September 2005

Sponsored by: Neurobiological Technologies
Information provided by: Neurobiological Technologies
ClinicalTrials.gov Identifier: NCT00226668

Purpose

The purpose of this study is to examine the safety and efficacy of human Corticotropin-Releasing Factor (hCRF) compared to dexamethasone in patients with primary malignant glioma who require increased dexamethasone doses to control symptom of peritumoral brain edema.
Condition Intervention Phase
Brain Edema
Brain Tumor
 Drug: XERECEPT (corticorelin acetate)
Phase III

MedlinePlus related topics:  Brain Cancer;   Brain Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: The primary efficacy endpoint is the proportion of reponders, 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. Improvement is defined as:; -Lower overall score on the 10-item Neurological Exam of at least 25% relative to Baseline, and; -Karnofsky Performance Score unchanged or increased relative to Baseline, and; -No post-Baseline increase in dexamethasone dose on more than 1 day, with a maximum allowable increase of less than 4mg on that day.
Expected Total Enrollment:  120

Study start: September 2005;  Expected completion: April 2007
Last follow-up: September 2005;  Data entry closure: March 2007

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 above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of a primary malignant glioma.
  • 10-item Neurological Exam confirms at least a 3-point total brain tumor related score at Baseline.
  • 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.
  • Karnofsky Performance of greater than or equal to 50 to greater than or equal to 90 at Screening and Baseline.
  • Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.
  • Life expectancy of at least 3 months at Screening.
  • Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
  • Women of childbearing potential must have a negative serum pregnancy test at Screening.
  • Must be 18 years of age or older.

Exclusion Criteria:

  • Need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment.
  • Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 2 weeks of treatment.
  • Systemic steroid use for any other indication than peritumoral brain edema.
  • Use or intended use of dexamethasone as an anti-emetic during Screening or Study. (Alternative anti-emetics such as Compazine, Anzemet, Zofran and Kytril may be considered)
  • Patients on dexamethasone or anticonvulsant therapy.
  • Clinical signs and symptoms of cerebral herniation.
  • Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which, in the opinion of the Investigator or the Medical Monitor, would 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 (CNS) infection.
  • Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
  • Conditions that are considered contradictions for patinets to receive niacin, e.g. liver disase with LFTs greater than or equal to 3.0 times the upper limit of the norm, active peptic ulcer, arterial hemorrhage, asthma and knwn hypersensitivity to niacin.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00226668

Lisa U. Carr, MD, PhD      510-595-6000 

Arizona
      Barrow Neurological Institute, Phoenix,  Arizona,  85013,  United States
William Shapiro, MD  602-406-6262    wshapiro@chw.edu 
William Shapiro, MD,  Principal Investigator

California
      UC San Diego Cancer Center, San Diego,  California,  92093,  United States
Jamiee Hartman  858-822-5354    jhartman@AD.UCSD.EDU 
John F Alksne, MD,  Principal Investigator

      Stanford University Medical Center, Palo Alto,  California,  94305,  United States
Lynn Adler, RN, BSN  650-725-8630    ladler@stanfordmed.org 
Lawrence Recht, MD,  Principal Investigator

      UC Davis Medical Center, Sacramento,  California,  95817,  United States
Cammy Rieger  916-806-7418    cammy.rieger@ucdmc.ucdavis.edu 
Robert O''''Donnell, MD,  Principal Investigator

      UCSF- Fresno MEP Center for Clinical Studies, Fresno,  California,  93703,  United States
Pave Volkov, MD  559-459-3846    PVolkov@fresno.ucsf.edu 
Loan Nguyen, MD,  Principal Investigator

Colorado
      Colorado Neurological Institute Center for Brain & Spinal Tumors, Englewood,  Colorado,  80113,  United States
Carol Greenwald, MD  303-806-7418    cgreenwald@thecni.org 
Edward Arenson, MD,  Principal Investigator

Florida
      Cancer Institute of Orlando, Orlando,  Florida,  32804,  United States
Sergey Bushnev, MD  407-303-5877    sergey.bushnev.md@flhosp.org 
Nicholas Avgeropoulos, MD,  Principal Investigator

      Moffitt Cancer Center and Research, Tampa,  Florida,  33612,  United States
Shirley Entis, RN  813-979-3929    entissa@moffitt.usf.edu 
Marc Chamberlin, MD,  Principal Investigator

Georgia
      Winship Cancer Institute, Emory University, Atlanta,  Georgia,  30322,  United States
Ellen McKenzie, RN  404-778-5344    ellen_mckenzie@emory.org 
Surasak Phuphanich, MD,  Principal Investigator

Illinois
      Northwestern University, Feinberg School of Medicine, Chicago,  Illinois,  60611,  United States
Jeffrey Raizer, MD  312-905-5489 
Jeffrey Raizer, MD,  Principal Investigator

Kentucky
      University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536,  United States
Nurdan Shafaghi  859-323-8527 
Byron Young, MD,  Principal Investigator

Massachusetts
      Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
Patrick Wenn, MD  617-632-2202    patrick_wen@dfci.harvard.edu 
Patrick Wenn, MD,  Principal Investigator

      Beth Isreal Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Loretta Barron, RN  617-667-1665    lbarron@caregroup.harvard.edu 
Eric Wong, MD,  Principal Investigator

Michigan
      Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
Ruth Ann Beasse, RN  313-916-5393    rbeasse1@hfhs.org 
Tom Mikkelson, MD,  Principal Investigator

New Jersey
      New Jersey Neuroscience Institute, Edison,  New Jersey,  08820,  United States
Joseph Landolfi, DO  732-321-7950    jlandolfi@solarishs.org 
Joseph Landolfi, DO,  Principal Investigator

New York
      Dent Neurologic Institute, Amherst,  New York,  14226,  United States
Malika Pasha  716-250-2028    mpasha@dentinstitute.org 
Laszlo Mechtler, MD,  Principal Investigator

      Memorial Sloan Kettering Cancer Center, New York,  New York,  10021,  United States
Chanda Casas  646-227-2267    casasc@MSKCC.org 
Adilia Hormigo, MD,  Principal Investigator

North Carolina
      Wake Forest University, Winston Salem,  North Carolina,  27106,  United States
Charollet Miller, RN  336-716-4031    chmiller@wfubmc.edu 
Stephen Tatter, MD,  Principal Investigator

Ohio
      The Ohio State University, Columbus,  Ohio,  43210,  United States
Jill Burkhart  614-293-5554    Burkart-1@medctr.osu.edu 
Herbert Newton, MD,  Principal Investigator

Pennsylvania
      Bodine Center for Cancer Treatment, Philadelphia,  Pennsylvania,  19107,  United States
Maria Wernder-Wasek, MD  215-955-6700 
Walter Curran, MD,  Principal Investigator

Tennessee
      Methodist Healthcare - University Hospital, Memphis,  Tennessee,  38103,  United States
Mary Jackson  901-259-8209    mjackson@semmes-murphey.com 
Allen Sills, MD,  Principal Investigator

      Vanderbilt University Medical Center, Nashville,  Tennessee,  37232,  United States
Kyle Weaver, MD  615-343-7417    Kyle.Weaver@vanderbilt.edu 
 615-322-8029 
Kyle Weaver, MD,  Principal Investigator

Utah
      Hunstman Cancer Institute - University of Utah, Salt Lake City,  Utah,  98111,  United States
Paige Preece  801-587-0160    paige.preece@utah.edu 
Deborah Blumenthal, MD,  Principal Investigator

Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53792,  United States
Diana Trask, RN  608-265-1700    trask@humonc.wisc.edu 
Ian H Robins, MD,  Principal Investigator

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G1ZT,  Canada
Dorcas Fulton, MD  780-432-8771    dorcas.fulton@cancerboard.ab.ca 
Dorcas Fulton, MD,  Principal Investigator

Canada, Ontario
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada
Nancy Page, RN  613-737-7700  Ext. 6866    napage@ohri.ca 
Stan Z Gertler, MD,  Principal Investigator

Canada, Saskatchewan
      Regina General Hospital, Regina,  Saskatchewan,  S4P 0W5,  Canada
Chris Ekong, MD  306-781-7229    ekong@hotmail.com 
Chris Ekong, MD,  Principal Investigator

Study chairs or principal investigators

William Shapiro, MD,  Principal Investigator,  Barrow Neurological Institute   

More Information

Study ID Numbers:  NTI-0302
Last Updated:  September 26, 2005
Record first received:  September 23, 2005
ClinicalTrials.gov Identifier:  NCT00226668
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27



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