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

February 27, 2007 updated by: Pacira Pharmaceuticals, Inc

A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E0V9
        • CancerCare Manitoba
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Toronto Sunnybrook Regional Cancer Center
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • University of Southern California, Norris Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80010
        • University of Colorado Hospital, Anschutz Cancer Pavilion
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center Hematology/Oncology
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic, Jacksonville
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic, Department of Neurosurgery
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center, Dept. of Hematology/Oncology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center Dept. of Neurology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Park Nicollet Institute, Oncology Research Program
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • JFK Neuroscience Institute
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University Hospital of Cleveland
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • San Antonio, Texas, United States, 78284
        • University of Texas Health Science Center
    • Utah
      • Salt lake City, Utah, United States, 84112
        • University of Utah, Hunsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival, defined as the time to neurological progression or death

Secondary Outcome Measures

Outcome Measure
Quality of life
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)
Cytological response rate
Overall safety profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacira Pharmaceuticals, Inc

Investigators

  • Study Director: Ahmet Tutuncu, MD, PhD, Pacira Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

January 15, 2002

First Submitted That Met QC Criteria

January 15, 2002

First Posted (Estimate)

January 16, 2002

Study Record Updates

Last Update Posted (Estimate)

February 28, 2007

Last Update Submitted That Met QC Criteria

February 27, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKY0101-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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