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DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

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ClinicalTrials.gov Identifier: NCT00029523
Recruitment Status : Completed
First Posted : January 16, 2002
Last Update Posted : February 28, 2007
Information provided by:
Pacira Pharmaceuticals, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Meningeal Neoplasms Drug: Intrathecal (injected into the spinal fluid) DepoCyt Drug: Intrathecal methotrexate Drug: Intrathecal cytarabine (also known as ara-C) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis
Study Start Date : April 2001
Estimated Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis
Drug Information available for: Cytarabine
U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival, defined as the time to neurological progression or death

Secondary Outcome Measures :
  1. Time to neurological progression;
  2. Survival (all-cause and meningeal disease-specific)
  3. Frequency of improvement in pre-existing meningeal-disease related neurological deficits
  4. Karnofsky Performance Scores (KPS)
  5. Quality of life
  6. Cytological response rate
  7. Overall safety profile

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia)
  • Diagnosed with neoplastic meningitis
  • If female, not pregnant and will not become pregnant while on-study
  • No other experimental therapy within 21 days of participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029523

  Show 23 Study Locations
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Study Director: Ahmet Tutuncu, MD, PhD Pacira Pharmaceuticals, Inc

ClinicalTrials.gov Identifier: NCT00029523     History of Changes
Other Study ID Numbers: SKY0101-010
First Posted: January 16, 2002    Key Record Dates
Last Update Posted: February 28, 2007
Last Verified: February 2007

Keywords provided by Pacira Pharmaceuticals, Inc:
cerebrospinal fluid
Leptomeningeal Neoplasms

Additional relevant MeSH terms:
Meningeal Carcinomatosis
Meningeal Neoplasms
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiviral Agents
Anti-Infective Agents