DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor
NCT ID: NCT00029523
Last Updated: 2007-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2001-04-30
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Intrathecal (injected into the spinal fluid) DepoCyt
Intrathecal methotrexate
Intrathecal cytarabine (also known as ara-C)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Principal Investigators
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Ahmet Tutuncu, MD, PhD
Role: STUDY_DIRECTOR
Pacira Pharmaceuticals, Inc
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
University of Southern California, Norris Cancer Center
Los Angeles, California, United States
University of Colorado Hospital, Anschutz Cancer Pavilion
Denver, Colorado, United States
Georgetown University Medical Center Hematology/Oncology
Washington D.C., District of Columbia, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory Clinic, Department of Neurosurgery
Atlanta, Georgia, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
Rush Cancer Institute
Chicago, Illinois, United States
Loyola University Medical Center, Dept. of Hematology/Oncology
Maywood, Illinois, United States
Beth Israel Deaconess Medical Center Dept. of Neurology
Boston, Massachusetts, United States
Park Nicollet Institute, Oncology Research Program
Minneapolis, Minnesota, United States
JFK Neuroscience Institute
Edison, New Jersey, United States
Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Case Western Reserve University Hospital of Cleveland
Cleveland, Ohio, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Utah, Hunsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Mason Medical Center
Seattle, Washington, United States
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Toronto Sunnybrook Regional Cancer Center
Toronto, Ontario, Canada
Countries
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References
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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.
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.
Other Identifiers
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SKY0101-010
Identifier Type: -
Identifier Source: org_study_id