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Brain Diseases |
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Clinical Trial: Human Corticotropin-Releasing Factor (hCRF) for Patients Requiring Chronic High-Doses of Dexamethasone to Treat Edema Associated with Malignant Brain Tumors
This study is currently recruiting patients.
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Purpose
The purpose of this study is to compare the safety and efficacy of XERECEPT™ to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.
XERECEPT™ is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
| Condition | Treatment or 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, Safety/Efficacy Study
Official Title: 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
Further Study Details:
Expected Total Enrollment: 200
Study start: May 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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 8-24 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 family/friend.
- Life expectancy of at least 4 months at Screening.
- 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. (Alternative anti-emetics such as Compazine, Anzemet, Zofran and Kytril may be considered.)
- 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, in the opinion of the Investigator or the Medical Monitor, would put the patient at unusual risk for study participation. (Patients receiving gastrointestinal prophylactic treatment at Baseline may continue.)
- 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 > 1.5 times of the upper limit of normal), active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin.
Location and Contact Information
Arizona
Barrow Neurological Institute, Phoenix, Arizona, 85013, United States; Recruiting
Greta Ludwig 602-406-6233 GLudwig2@chw.edu
Shapiro William, MD, Principal Investigator
Shapiro William, MD, Principal Investigator
California
UC San Diego, Thornton Hospital, San Diego, California, 92037, United States; Not yet recruiting
Vineeta Prasad 858-657-7028 vprasad@ucsd.edu
JOHN F ALKSNE, MD, Principal Investigator
JOHN F ALKSNE, MD, Principal Investigator
University of Southern California, Los Angeles, California, 90038, United States; Not yet recruiting
Natalie Scheiner, CNP 323-865-3045 natalie-rn@worldnet.att.net
Marc Chamberlain, MD, Principal Investigator
Marc Chamberlain, MD, Principal Investigator
Cedars-Sinai Medical Center, Neurosurgical Institute, Los Angeles, California, 90048, United States; Not yet recruiting
Diane Tryciecky, RN, BSN, OCN 310-423-2313
Asha Das, MD, Principal Investigator
Asha Das, MD, Principal Investigator
UC Davis Medical Center, Division of Medical Oncology, Sacramento, California, 95817, United States; Not yet recruiting
Garrett Tischauer 916-734-5840 garrett.techauer@ucdmc.ucdavis.edu
Robert O'Donnell, MD, Principal Investigator
Robert O'Donnell, MD, Principal Investigator
Colorado
Colorado Neurological Institute, Englewood, Colorado, 80113, United States; Not yet recruiting
Carol Greenwald, MD 303-806-7418 cgreenwald@thecni.org
Edward Arenson, MD, Principal Investigator
Edward Arenson, MD, Principal Investigator
University of Colorado Cancer Center, Aurora, Colorado, 80045, United States; Not yet recruiting
Monica Robischon, RN 720-848-0661 Monica.Robischon@uchsc.edu
Denise Damek, MD, Principal Investigator
Denise Damek, MD, Principal Investigator
Florida
Cancer Institute of Orlando, Orlando, Florida, 32804, United States; Not yet recruiting
Sergey Bushnev, MD 407-303-5877 sergey.bushnev.md@flhosp.org
Nicholas Avgeropoulos, MD, Principal Investigator
Nicholas Avgeropoulos, MD, Principal Investigator
Mayo Clinic, Jacksonville, Florida, 32224, United States; Not yet recruiting
Bryan Courtney 904-953-6806 courtney.bryan@mayo.edu
Kurt Jaeckle, MD, Principal Investigator
Kurt Jaeckle, MD, Principal Investigator
Moffitt Cancer Center & Research Institute, Tampa, Florida, 33612-9497, United States; Not yet recruiting
Shirley Entis 813-979-3929 entissa@moffitt.usf.edu
Georgia
Winship Cancer Institute, Emory University, Atlanta, Georgia, 30322, United States; Recruiting
Ellen McKenzie, RN, CCRC 404-778-5344 ellen_mckenzie@emory.org
Surasak Phuphanich, MD, Principal Investigator
Surasak Phuphanich, MD, Principal Investigator
Illinois
Northwestern University, Feinberg School of Medicine, Chicago, Illinois, United States; Not yet recruiting
Tia Kanranu 312-695-1387 b-kanranu@northwestern.edu
Jeffrey Raizer, MD, Principal Investigator
Jeffrey Raizer, MD, Principal Investigator
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Not yet recruiting
Joanna Bradshaw 617-632-6589 jbradshaw1@partners.org
Patrick Wen, MD, Principal Investigator
Patrick Wen, MD, Principal Investigator
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Not yet recruiting
Loretta Barron, RN 617-667-1665 lbarron@caregroup.harvard.edu
Eric Wong, MD, Principal Investigator
Eric Wong, MD, Principal Investigator
New Jersey
New Jersey Neuroscience Institute, Edison, New Jersey, 08820, United States; Not yet recruiting
Deviyani Mehta, MD 732-321-7000 Ext. 68897 dmehta@solarishs.org
Joseph Landolfi, DO, Principal Investigator
Joseph Landolfi, DO, Principal Investigator
New York
Memorial Sloan Kettering Cancer Center, New York, New York, 10021, United States; Not yet recruiting
Bertha Fearon 646-227-2064 FearonB@mskcc.org
Adilia Hormigo, MD, Principal Investigator
Adilia Hormigo, MD, Principal Investigator
Dent Neurologic Institute, Amherst, New York, 14226, United States; Not yet recruiting
Malika Pasha 716-250-2028 mpasha@dentinstitute.com
Laszlo Mechtler, MD, Principal Investigator
Laszlo Mechtler, MD, Principal Investigator
Texas
The Methodist Hospital, Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Toni Rudersdorf 713-798-6519 trr@bcm.tmc.edu
Pamela New, MD, Principal Investigator
Pamela New, MD, Principal Investigator
Utah
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, 84112, United States; Not yet recruiting
Hugh Spilker 801-587-7604 hugh.spilker@hci.utah.edu
Julia Batten, NP julia.batten@hsc.utah.edu
Deborah Blumenthal, MD, Principal Investigator
Julia Batten, NP julia.batten@hsc.utah.edu
Deborah Blumenthal, MD, Principal Investigator
Washington
Virginia Mason Clinic, Seattle, Washington, 98111, United States; Not yet recruiting
Katharine Franklin Katharine.Franklin@vmmc.org
Lynne Taylor,, MD, Principal Investigator
Lynne Taylor,, MD, Principal Investigator
Canada, Alberta
Cross Cancer Institute, Edmonton, Alberta, T6G1ZT, Canada; Not yet recruiting
Shelley Sass 780-432-8595 shelleys@cancerboard.ab.ca
Dorcas Fulton, MD, Principal Investigator
Dorcas Fulton, MD, Principal Investigator
Canada, Manitoba
CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada; Not yet recruiting
Barb Ameter 204.787.4105 Ext. 2140 barb.ammeter@cancercare.mb.ca
David Eisenstat, MD, Principal Investigator
David Eisenstat, MD, Principal Investigator
Canada, Nova Scotia
Nova Scotia Cancer Centre, Halifax, Nova Scotia, B3H 4K6, Canada; Not yet recruiting
Sarah Kirby, MD 902-492-2220
Sarah Kirby, MD, Principal Investigator
Sarah Kirby, MD, Principal Investigator
Canada, Ontario
Ottawa Regional Cancer Centre, Ottawa, Ontario, K1H 1C4, Canada; Not yet recruiting
Nancy Page 613-737-7700 Ext. 6866 napage@ohri.ca
Stan Z Gertler, MD, Principal Investigator
Stan Z Gertler, MD, Principal Investigator
Kingston General Hospital, Kingston, Ontario, K7L 5P9, Canada; Not yet recruiting
Ivan Agatiello (613) 544-2631 Ext. 6736 Ivan.Agatiello@krcc.on.ca
Yolanda Madarnas, MD, Principal Investigator
Yolanda Madarnas, MD, Principal Investigator
Sunnybrook and Women’s College Health, Toronto, Ontario, M4N 3M5, Canada; Not yet recruiting
Rosemary Cashman 416-480-6100 Ext. 7364 rosemaryc@swchsc.on.ca
Perry James, MD, Principal Investigator
Perry James, MD, Principal Investigator
Canada, Quebec
Montreal Neurological Institute, Montreal, Quebec, H3A 2B4, Canada; Not yet recruiting
Richard LEBLANC, MD 514-398-1939
Canada, Saskatchewan
Regina General Hospital, Regina, Saskatchewan, S4P 0W5, Canada; Not yet recruiting
Marilyn Reid, RN, BScN, MBA 306-525-3586 drfveloso@sasktel.net
Chris Ekong, MD, Principal Investigator
Chris Ekong, MD, Principal Investigator
More Information
Study ID Numbers: NTI 0303; XERECEPT™; corticorelin acetate
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: July 20, 2004
ClinicalTrials.gov Identifier: NCT00088166
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: July 20, 2004
ClinicalTrials.gov Identifier: NCT00088166
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Acute Disseminated Encephalomyelitis (National Institute of Neurological Diseases and Stroke)
- Acute Disseminated Encephalomyelitis (National Institute of Neurological Disorders and Stroke)
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