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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
Not Enrolling
Both
Meningeal Neoplasms

Thank you

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 InstituteTampa, Florida  33612
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Virginia Mason Medical CenterSeattle, Washington  98111
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Rush Cancer InstituteChicago, Illinois  60612
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Barrow Neurological InstitutePhoenix, Arizona  85013
University of Southern California, Norris Cancer CenterLos Angeles, California  90033
University of Colorado Hospital, Anschutz Cancer PavilionDenver, Colorado  80010
Georgetown University Medical Center Hematology/OncologyWashington, District of Columbia  20007
Mayo Clinic, JacksonvilleJacksonville, Florida  32224
Emory Clinic, Department of NeurosurgeryAtlanta, Georgia  30322
Straub Clinic and HospitalHonolulu, Hawaii  96813
Loyola University Medical Center, Dept. of Hematology/OncologyMaywood, Illinois  60153
Beth Israel Deaconess Medical Center Dept. of NeurologyBoston, Massachusetts  02215
Park Nicollet Institute, Oncology Research ProgramMinneapolis, Minnesota  55416
JFK Neuroscience InstituteEdison, New Jersey  08820
Bowman Gray School of Medicine/Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina  27157
Case Western Reserve University Hospital of ClevelandCleveland, Ohio  44106
University of Texas Health Science CenterSan Antonio, Texas  78284
University of Utah, Hunsman Cancer InstituteSalt lake City, Utah  84112