hCRF for Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema Associated with Primary Malignant Glioma - Article Water Retention
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
|Brain Edema |
| 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
Expected Total Enrollment: 120
Study start: September 2005; Expected completion: April 2007
Last follow-up: September 2005; Data entry closure: March 2007
Accepts Healthy Volunteers
- 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.
- 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
Barrow Neurological Institute, Phoenix, Arizona, 85013, United States
William Shapiro, MD, Principal Investigator
UC San Diego Cancer Center, San Diego, California, 92093, United States
John F Alksne, MD, Principal Investigator
Stanford University Medical Center, Palo Alto, California, 94305, United States
Lawrence Recht, MD, Principal Investigator
UC Davis Medical Center, Sacramento, California, 95817, United States
Robert O''''Donnell, MD, Principal Investigator
UCSF- Fresno MEP Center for Clinical Studies, Fresno, California, 93703, United States
Loan Nguyen, MD, Principal Investigator
Colorado Neurological Institute Center for Brain & Spinal Tumors, Englewood, Colorado, 80113, United States
Edward Arenson, MD, Principal Investigator
Cancer Institute of Orlando, Orlando, Florida, 32804, United States
Nicholas Avgeropoulos, MD, Principal Investigator
Moffitt Cancer Center and Research, Tampa, Florida, 33612, United States
Marc Chamberlin, MD, Principal Investigator
Winship Cancer Institute, Emory University, Atlanta, Georgia, 30322, United States
Surasak Phuphanich, MD, Principal Investigator
Northwestern University, Feinberg School of Medicine, Chicago, Illinois, 60611, United States
Jeffrey Raizer, MD, Principal Investigator
University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536, United States
Byron Young, MD, Principal Investigator
Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States
Patrick Wenn, MD, Principal Investigator
Beth Isreal Deaconess Medical Center, Boston, Massachusetts, 02215, United States
Eric Wong, MD, Principal Investigator
Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, Michigan, 48202, United States
Tom Mikkelson, MD, Principal Investigator
New Jersey Neuroscience Institute, Edison, New Jersey, 08820, United States
Joseph Landolfi, DO, Principal Investigator
Dent Neurologic Institute, Amherst, New York, 14226, United States
Laszlo Mechtler, MD, Principal Investigator
Memorial Sloan Kettering Cancer Center, New York, New York, 10021, United States
Adilia Hormigo, MD, Principal Investigator
Wake Forest University, Winston Salem, North Carolina, 27106, United States
Stephen Tatter, MD, Principal Investigator
The Ohio State University, Columbus, Ohio, 43210, United States
Herbert Newton, MD, Principal Investigator
Bodine Center for Cancer Treatment, Philadelphia, Pennsylvania, 19107, United States
Walter Curran, MD, Principal Investigator
Methodist Healthcare - University Hospital, Memphis, Tennessee, 38103, United States
Allen Sills, MD, Principal Investigator
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
Kyle Weaver, MD, Principal Investigator
Hunstman Cancer Institute - University of Utah, Salt Lake City, Utah, 98111, United States
Deborah Blumenthal, MD, Principal Investigator
University of Wisconsin, Madison, Wisconsin, 53792, United States
Ian H Robins, MD, Principal Investigator
Cross Cancer Institute, Edmonton, Alberta, T6G1ZT, Canada
Dorcas Fulton, MD, Principal Investigator
Ottawa Regional Cancer Centre, Ottawa, Ontario, K1H 1C4, Canada
Stan Z Gertler, MD, Principal Investigator
Regina General Hospital, Regina, Saskatchewan, S4P 0W5, Canada
Chris Ekong, MD, Principal Investigator
William Shapiro, MD, Principal Investigator, Barrow Neurological Institute
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
- ClinicalTrials.gov: Edema (National Institutes of Health)
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