Clinical trial NCT00029523: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningeal Neoplasms
Keywords: neoplastic
meningitis
cerebrospinal fluid
CSF
meningeal
meninges
CNS
Leptomeningeal Neoplasms
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2002-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free survival, defined as the time to neurological progression or death
Secondary outcomes:
measure: Time to neurological progression;
measure: Survival (all-cause and meningeal disease-specific)
measure: Frequency of improvement in pre-existing meningeal-disease related neurological deficits
measure: Karnofsky Performance Scores (KPS)
measure: Quality of life
measure: Cytological response rate
measure: Overall safety profile
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California, Norris Cancer Center
state: California
city: Denver
country: United States
facility: University of Colorado Hospital, Anschutz Cancer Pavilion
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center Hematology/Oncology
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic, Jacksonville
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Clinic, Department of Neurosurgery
state: Georgia
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Chicago
country: United States
facility: Rush Cancer Institute
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center, Dept. of Hematology/Oncology
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center Dept. of Neurology
state: Massachusetts
city: Minneapolis
country: United States
facility: Park Nicollet Institute, Oncology Research Program
state: Minnesota
city: Edison
country: United States
facility: JFK Neuroscience Institute
state: New Jersey
city: Winston-Salem
country: United States
facility: Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University Hospital of Cleveland
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt lake City
country: United States
facility: University of Utah, Hunsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Center
state: Ontario
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Ahmet Tutuncu, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.