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

This study has been completed.
Sponsor:
Information provided by:
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00029523
First received: January 15, 2002
Last updated: February 27, 2007
Last verified: February 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 15, 2002
Last Updated: February 27, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 18, 2013