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

Primary Purpose

Meningeal Neoplasms

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Intrathecal (injected into the spinal fluid) DepoCyt
Intrathecal methotrexate
Intrathecal cytarabine (also known as ara-C)
Sponsored by
Pacira Pharmaceuticals, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningeal Neoplasms focused on measuring neoplastic, meningitis, cerebrospinal fluid, CSF, meningeal, meninges, CNS, Leptomeningeal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Institute
  • Alta Bates Comprehensive Cancer Center
  • University of Southern California, Norris Cancer Center
  • University of Colorado Hospital, Anschutz Cancer Pavilion
  • Georgetown University Medical Center Hematology/Oncology
  • Mayo Clinic, Jacksonville
  • H. Lee Moffitt Cancer Center and Research Institute
  • Emory Clinic, Department of Neurosurgery
  • Straub Clinic and Hospital
  • Rush Cancer Institute
  • Loyola University Medical Center, Dept. of Hematology/Oncology
  • Beth Israel Deaconess Medical Center Dept. of Neurology
  • Park Nicollet Institute, Oncology Research Program
  • JFK Neuroscience Institute
  • Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University
  • Case Western Reserve University Hospital of Cleveland
  • University of Pittsburgh Cancer Institute
  • Vanderbilt University Medical Center
  • University of Texas Health Science Center
  • University of Utah, Hunsman Cancer Institute
  • Virginia Mason Medical Center
  • CancerCare Manitoba
  • Toronto Sunnybrook Regional Cancer Center

Outcomes

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

Full Information

First Posted
January 15, 2002
Last Updated
February 27, 2007
Sponsor
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00029523
Brief Title
DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor
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 Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pacira Pharmaceuticals, Inc

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningeal Neoplasms
Keywords
neoplastic, meningitis, cerebrospinal fluid, CSF, meningeal, meninges, CNS, Leptomeningeal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intrathecal (injected into the spinal fluid) DepoCyt
Intervention Type
Drug
Intervention Name(s)
Intrathecal methotrexate
Intervention Type
Drug
Intervention Name(s)
Intrathecal cytarabine (also known as ara-C)
Primary Outcome Measure Information:
Title
Progression-free survival, defined as the time to neurological progression or death
Secondary Outcome Measure Information:
Title
Time to neurological progression;
Title
Survival (all-cause and meningeal disease-specific)
Title
Frequency of improvement in pre-existing meningeal-disease related neurological deficits
Title
Karnofsky Performance Scores (KPS)
Title
Quality of life
Title
Cytological response rate
Title
Overall safety profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Tutuncu, MD, PhD
Organizational Affiliation
Pacira Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
University of Southern California, Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Colorado Hospital, Anschutz Cancer Pavilion
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Georgetown University Medical Center Hematology/Oncology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Clinic, Department of Neurosurgery
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Rush Cancer Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Medical Center, Dept. of Hematology/Oncology
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Beth Israel Deaconess Medical Center Dept. of Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Park Nicollet Institute, Oncology Research Program
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
JFK Neuroscience Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Case Western Reserve University Hospital of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
University of Utah, Hunsman Cancer Institute
City
Salt lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0V9
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10589750
Citation
Glantz MJ, Jaeckle KA, Chamberlain MC, Phuphanich S, Recht L, Swinnen LJ, Maria B, LaFollette S, Schumann GB, Cole BF, Howell SB. A randomized controlled trial comparing intrathecal sustained-release cytarabine (DepoCyt) to intrathecal methotrexate in patients with neoplastic meningitis from solid tumors. Clin Cancer Res. 1999 Nov;5(11):3394-402.
Results Reference
background
PubMed Identifier
10506606
Citation
Glantz MJ, LaFollette S, Jaeckle KA, Shapiro W, Swinnen L, Rozental JR, Phuphanich S, Rogers LR, Gutheil JC, Batchelor T, Lyter D, Chamberlain M, Maria BL, Schiffer C, Bashir R, Thomas D, Cowens W, Howell SB. Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. J Clin Oncol. 1999 Oct;17(10):3110-6. doi: 10.1200/JCO.1999.17.10.3110.
Results Reference
background

Learn more about this trial

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

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