DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor
Information source: Pacira Pharmaceuticals, Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningeal Neoplasms
Intervention: Intrathecal (injected into the spinal fluid) DepoCyt (Drug); Intrathecal methotrexate (Drug); Intrathecal cytarabine (also known as ara-C) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pacira Pharmaceuticals, Inc Official(s) and/or principal investigator(s):
Ahmet Tutuncu, MD, PhD, Study Director, Affiliation: Pacira Pharmaceuticals, Inc
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Progression-free survival, defined as the time to neurological progression or death
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Barrow Neurological Institute, Phoenix, Arizona 85013, United States
University of Southern California, Norris Cancer Center, Los Angeles, California 90033, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California 94704, United States
University of Colorado Hospital, Anschutz Cancer Pavilion, Denver, Colorado 80010, United States
Georgetown University Medical Center Hematology/Oncology, Washington, District of Columbia 20007, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States
Mayo Clinic, Jacksonville, Jacksonville, Florida 32224, United States
Emory Clinic, Department of Neurosurgery, Atlanta, Georgia 30322, United States
Straub Clinic and Hospital, Honolulu, Hawaii 96813, United States
Rush Cancer Institute, Chicago, Illinois 60612, United States
Loyola University Medical Center, Dept. of Hematology/Oncology, Maywood, Illinois 60153, United States
CancerCare Manitoba, Winnipeg, Manitoba R3E0V9, Canada
Beth Israel Deaconess Medical Center Dept. of Neurology, Boston, Massachusetts 02215, United States
Park Nicollet Institute, Oncology Research Program, Minneapolis, Minnesota 55416, United States
JFK Neuroscience Institute, Edison, New Jersey 08820, United States
Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina 27157, United States
Case Western Reserve University Hospital of Cleveland, Cleveland, Ohio 44106, United States
Toronto Sunnybrook Regional Cancer Center, Toronto, Ontario M4N3M5, Canada
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213, United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
University of Texas Health Science Center, San Antonio, Texas 78284, United States
University of Utah, Hunsman Cancer Institute, Salt lake City, Utah 84112, United States
Virginia Mason Medical Center, Seattle, Washington 98101, United States
Additional Information
Related publications: 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.
Starting date: April 2001
Ending date: November 2004
Last updated: February 27, 2007
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