A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Meningeal Neoplasms
Both
Meningeal Neoplasms
Trial Information
A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival, defined as the time to neurological progression or death
Principal Investigator
Ahmet Tutuncu, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Pacira Pharmaceuticals, Inc
Authority:
United States: Food and Drug Administration
Study ID:
SKY0101-010
NCT ID:
NCT00029523
Start Date:
April 2001
Completion Date:
November 2004
Related Keywords:
- Meningeal Neoplasms
- neoplastic
- meningitis
- cerebrospinal fluid
- CSF
- meningeal
- meninges
- CNS
- Leptomeningeal Neoplasms
- Neoplasms
- Meningeal Neoplasms
- Meningitis
- Meningeal Carcinomatosis
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Virginia Mason Medical Center | Seattle, Washington 98111 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Rush Cancer Institute | Chicago, Illinois 60612 |
| Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
| Barrow Neurological Institute | Phoenix, Arizona 85013 |
| University of Southern California, Norris Cancer Center | Los Angeles, California 90033 |
| University of Colorado Hospital, Anschutz Cancer Pavilion | Denver, Colorado 80010 |
| Georgetown University Medical Center Hematology/Oncology | Washington, District of Columbia 20007 |
| Mayo Clinic, Jacksonville | Jacksonville, Florida 32224 |
| Emory Clinic, Department of Neurosurgery | Atlanta, Georgia 30322 |
| Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
| Loyola University Medical Center, Dept. of Hematology/Oncology | Maywood, Illinois 60153 |
| Beth Israel Deaconess Medical Center Dept. of Neurology | Boston, Massachusetts 02215 |
| Park Nicollet Institute, Oncology Research Program | Minneapolis, Minnesota 55416 |
| JFK Neuroscience Institute | Edison, New Jersey 08820 |
| Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University | Winston-Salem, North Carolina 27157 |
| Case Western Reserve University Hospital of Cleveland | Cleveland, Ohio 44106 |
| University of Texas Health Science Center | San Antonio, Texas 78284 |
| University of Utah, Hunsman Cancer Institute | Salt lake City, Utah 84112 |
