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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00029523
First Posted: January 16, 2002
Last Update Posted: February 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pacira Pharmaceuticals, Inc
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

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

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

Estimated Enrollment: 100
Study Start Date: April 2001
Estimated Study Completion Date: November 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
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
Investigators
Study Director: Ahmet Tutuncu, MD, PhD Pacira Pharmaceuticals, Inc
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00029523     History of Changes
Other Study ID Numbers: SKY0101-010
First Submitted: January 15, 2002
First Posted: January 16, 2002
Last Update Posted: February 28, 2007
Last Verified: February 2007

Keywords provided by Pacira Pharmaceuticals, Inc:
neoplastic
meningitis
cerebrospinal fluid
CSF
meningeal
meninges
CNS
Leptomeningeal Neoplasms

Additional relevant MeSH terms:
Meningitis
Meningeal Carcinomatosis
Meningeal Neoplasms
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Methotrexate
Cytarabine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
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