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| Sponsor: | Pacira Pharmaceuticals, Inc |
|---|---|
| Information provided by: | Pacira Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00029523 |
Purpose
The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningeal Neoplasms |
Drug: Intrathecal (injected into the spinal fluid) DepoCyt Drug: Intrathecal methotrexate Drug: Intrathecal cytarabine (also known as ara-C) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis |
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| University of Southern California, Norris Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| United States, Colorado | |
| University of Colorado Hospital, Anschutz Cancer Pavilion | |
| Denver, Colorado, United States, 80010 | |
| United States, District of Columbia | |
| Georgetown University Medical Center Hematology/Oncology | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Mayo Clinic, Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| Emory Clinic, Department of Neurosurgery | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Straub Clinic and Hospital | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Rush Cancer Institute | |
| Chicago, Illinois, United States, 60612 | |
| Loyola University Medical Center, Dept. of Hematology/Oncology | |
| Maywood, Illinois, United States, 60153 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center Dept. of Neurology | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Park Nicollet Institute, Oncology Research Program | |
| Minneapolis, Minnesota, United States, 55416 | |
| United States, New Jersey | |
| JFK Neuroscience Institute | |
| Edison, New Jersey, United States, 08820 | |
| United States, North Carolina | |
| Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Case Western Reserve University Hospital of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78284 | |
| United States, Utah | |
| University of Utah, Hunsman Cancer Institute | |
| Salt lake City, Utah, United States, 84112 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E0V9 | |
| Canada, Ontario | |
| Toronto Sunnybrook Regional Cancer Center | |
| Toronto, Ontario, Canada, M4N3M5 | |
| Study Director: | Ahmet Tutuncu, MD, PhD | Pacira Pharmaceuticals, Inc |
More Information
| Study ID Numbers: | SKY0101-010 |
| Study First Received: | January 15, 2002 |
| Last Updated: | February 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00029523 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
neoplastic meningitis cerebrospinal fluid CSF |
meningeal meninges CNS Leptomeningeal Neoplasms |
|
Antimetabolites Anti-Infective Agents Meningeal Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Central Nervous System Neoplasms Reproductive Control Agents Meningitis Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Cytarabine Nervous System Neoplasms Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Central Nervous System Infections Antirheumatic Agents |
