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Sponsored by: |
Pacira Pharmaceuticals, Inc |
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Information provided by: | Pacira Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00029523 |
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 |
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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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study Director: | Ahmet Tutuncu, MD, PhD | Pacira Pharmaceuticals, Inc |
Study ID Numbers: | SKY0101-010 |
Study First Received: | January 15, 2002 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00029523 |
Health Authority: | United States: Food and Drug Administration |
neoplastic meningitis cerebrospinal fluid CSF |
meningeal meninges CNS Leptomeningeal Neoplasms |
Folic Acid Meningeal Neoplasms Central Nervous System Infections Methotrexate Central Nervous System Diseases |
Central Nervous System Neoplasms Lymphoma Cytarabine Nervous System Neoplasms Meningitis |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists |
Abortifacient Agents, Nonsteroidal Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |